Dermatology Times

Clinical Analysis for Todays Skincare Specialists

In This Issue

August 2014

VOL. 35, NO. 8

CLINICAL 18

Single-dose tablet
effective for labial herpes
August 2014

New delivery system of established

drug increases efficacy

COSMETIC 28

Incorporating lasers

Volume 35 No. 8

How to ensure youre choosing wisely

ONCOLOGY 50

August 2014

VOL. 35, NO. 8

Complement
or competitor?
Experts weigh in on the role for electronic surface
brachytherapy in the dermatologists office

Managing locally
advanced BCC

Clinical Analysis for Todays Skincare Specialists

Electronic surface brachytherapy uses a portable

machine (Xoft Axxent Electronic Brachytherapy
System; iCAD) about the size of a laser to generate
IMPORTANT SAFETY INFORMATION
BUSINESS
66
INDICATIONS: This product is indicated for use in the topicalprecise,
control ofaccurately targeted doses of radiation applied


Insurance exchange,
through an applicator placed directly on the skin.
Determining appropriate
treatment strategies

ACO pressures mounting

CONTRAINDICATIONS: This product is contraindicated in persons

Photos:with
Philip Werschler, M.D.


Dermatologists face increasing
d

pressure to prove their value
WARNINGS: Sulfonamides are known to cause Stevens-Johnson

88
 ^: 
THETAKEAWAY
also has been reported following the use of sodium sulfacetamide
       
/
KEEP
OUT impacting
OF THE REACH OF CHILDREN.
As a primary factor

Medication
adherence

success,
PRECAUTIONS: treatment
FOR EXTERNAL
USE Steven
ONLY. NOT FOR OPHTHALMIC
Feldman, M.D., discusses the
USE.
important
adherence
plays   
' E
role


in patient management


d
FOLLOW
US ONLINE:

 
     

   /        
         
 W       

      ^ 
Clinical
       
       
   W   
^
       
        
Jesitus
h       John

 | Senior Staff Correspondent
        
John Jesitus | Senior Staff Correspondent
      
Electronic surface brachytherapy allows derma
SUCCESSFULLY managing cutaneous drug

DermatologyTimes.com

Cutaneous drug
reaction diagnoses
require art, urgency

DermatologyTimes.com

tologists to offer patients another safe, effective

reactions
including
drug reacd
 requires
 
  
 
option
for nonmelanoma skin cancer (NMSC),










tions in the differential diagnosis of most

  
and
d
   


many
experts
say. And if the specialty doesnt
cutaneous
eruptions,
recognizing


seize
the opportunity, they add, it might lose some
severe reactions where treatment may

skin cancer treatments to radiation oncologists.
improve outcomes, an expert says.
ADVERSE REACTIONS: Z     
Diagnosing cutaneous drug reacThe appeal of electronic surface brachy    d  
tions
is almost 
an art, says
David R.
therapy to the dermatology community is that



Adams, M.D.,
sulfacetamide,
are Pharm.D.,
noteworthy:professor
instances of
of Stevens-Johnson
this is something performed in our offices

 
 

  
dermatology
at Penn
State
Hershey
that has a cure rate, as best we understand it,
to aMedical
syndromeCenter,
resembling
systemic lupus
erythematosus; in one case
Hershey,
Pennsylvathat approximates that of Mohs surgery, says
tZE/E'^
nia. Usually its based on the clinical
Wm. Philip Werschler, M.D., a dermatologist
WW/
appearance of the reaction
and evaluain Spokane, Washington, and assistant clinical
tion of the timing of medication adminprofessor of medicine/dermatology, University of
istration. This can vary, depending on
Washington School of Medicine, Seattle.
the type of reaction.
Copyright 2014 Mission
Pharmacal Company.
DRUG REACTIONS
see page 25
Electronic surface brachytherapy is also
All rights reserved.

AVA-14111

patient- and physician-friendly, he says. The iCAD

Xoft Axxent Electronic Brachytherapy System was
cleared by the Food and Drug Administration in
2009 for the treatment of NMSC. Typical treatment
protocol using the system includes two treatments
weekly for four weeks, versus 25 to 40 treatments
total (three to five treatments weekly) with traditional radiotherapy, says Dr. Werschler, who offers
electronic surface brachytherapy for NMSC in his
*
#
office.
Brand
Traditional radiotherapy alsoSodium
suffers
from an
Sulfacetamide
& Sulfur he says.
image problem with respect to NMSC,
Along with the inconvenience of visiting a cancer
center for months on end, Patients with skin
cancer dont see themselves as being sick. Theyre

*Source Healthcare Analytics PHAST Prescription data, accessed October 2013.

BRACHYTHERAPY see page 59

AVAR Cleansing Pads

(sodium sulfacetamide 9.5%, sulfur 5%)
Rx Only
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION: Each pad is coated with a
cleanser-based formulation. Each gram of solution
contains 95 mg of sodium sulfacetamide and 50
mg of colloidal sulfur in a vehicle consisting of:
benzyl alcohol, cetyl alcohol, fragrance, glyceryl
stearate (and) PEG-100 stearate, magnesium
aluminum silicate, phenoxyethanol, propylene
glycol, purified water, sodium lauryl sulfate,
sodium magnesium silicate, sodium thiosulfate,
stearyl alcohol and xanthan gum.
Sodium sulfacetamide is a sulfonamide with
antibacterial activity while sulfur acts as a
keratolytic agent. Sodium sulfacetamide is
C8H9N2NaO3SH2O with molecular weight of
254.24. Chemically, sodium sulfacetamide is
N-[(4-aminophenyl) sulfonyl]-acetamide,
monosodium salt, monohydrate. The structural
formula is:

The exact mode of action of sulfur in the treatment

of acne is unknown, but it has been reported that it
inhibits the growth of Propionibacterium acnes and
the formation of free fatty acids.
INDICATIONS: This product is indicated for use in
the topical control of acne vulgaris, acne rosacea
and seborrheic dermatitis.
CONTRAINDICATIONS: This product is contraindicated
in persons with known or suspected hypersensitivity
to any of the ingredients of the product. This product
is not to be used by patients with kidney disease.
WARNINGS: Sulfonamides are known to cause
Stevens-Johnson syndrome in hypersensitive
individuals. Stevens-Johnson syndrome also has
been reported following the use of sodium
sulfacetamide topically. Cases of drug-induced
systemic lupus erythematosus from topical
sulfacetamide also have been reported. In one of
these cases, there was a fatal outcome.
KEEP OUT OF THE REACH OF CHILDREN.
PRECAUTIONS: FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
General: Nonsusceptible organisms, including fungi,
may proliferate with the use of this preparation.

Sodium sulfacetamide is an odorless, white,

crystalline powder with a bitter taste. It is freely
soluble in water, sparingly soluble in alcohol,
while practically insoluble in benzene, in
chloroform and in ether.
CLINICAL PHARMACOLOGY: Sodium sulfacetamide
exerts a bacteriostatic effect against sulfonamide
sensitive Gram-positive and Gram-negative
microorganisms commonly isolated from secondary
cutaneous pyogenic infections. It acts by restricting
the synthesis of folic acid required by bacteria for
growth, by its competition with para-aminobenzoic
acid. There is no clinical data available on the
degree and rate of systemic absorption of this
product when applied to the skin or scalp. However,
significant absorption of sodium sulfacetamide
through the skin has been reported.
The following in vitro data is available but the clinical
significance is unknown. Organisms that show
susceptibility to sodium sulfacetamide are:
Streptococci, Staphylococci, E. coli, Klebsiella
pneumoniae, Pseudomonas pyocyanea, Salmonella
species, Proteus vulgaris, Nocardia and Actinomyces.

Although rare, sensitivity to sodium sulfacetamide

may occur. Therefore, caution and careful
supervision should be observed when prescribing
this drug for patients who may be prone to
hypersensitivity to topical sulfonamides. If the use
of this product produces signs of hypersensitivity
or other untoward reactions, discontinue use of the
preparation. Patients should be carefully observed
for possible local irritation or sensitization during
long-term therapy. Systemic toxic reactions such
as agranulocytosis, acute hemolytic anemia,
purpura hemorrhagica, drug fever, jaundice and
contact dermatitis indicate hypersensitivity to
sulfonamides. Particular caution should be
employed if areas of denuded or abraded skin are
involved. Systemic absorption of topical
sulfonamides is greater following application to
large, infected, abraded, denuded or severely
burned areas. Under these circumstances, any of
the adverse effects produced by the systemic
administration of these agents could potentially
occur, and appropriate observations and laboratory
determinations should be performed.

desquamation without irritation, but sodium

sulfacetamide and sulfur can cause reddening and
scaling of the epidermis. These side effects are
not unusual in the treatment of acne vulgaris, but
patients should be cautioned about the possibility.
Information for Patients: Patients should
discontinue the use of this product if the condition
becomes worse or if a rash develops in the area
being treated or elsewhere. The use of this
product also should be discontinued promptly and
the physician notified if any arthritis, fever or sores
in the mouth develop. Avoid contact with eyes, lips
and mucous membranes.
Drug Interactions: This product is incompatible
with silver preparations.
Carcinogenesis, Mutagenesis and Impairment
of Fertility: Long-term animal studies for
carcinogenic potential have not been performed on
this product to date. Studies on reproduction and
fertility also have not been performed.
Chromosomal nondisjunction has been reported in
the yeast, Saccharomyces cerevisiae, following
application of sodium sulfacetamide. The
significance of this finding to the topical use of
sodium sulfacetamide in the human is unknown.
Pregnancy: Category C. Animal reproduction
studies have not been conducted with this
product. It is also not known whether this product
can affect reproduction capacity or cause fetal
harm when administered to a pregnant woman.
This product should be used by a pregnant woman
only if clearly needed or when potential benefits
outweigh potential hazards to the fetus.
Nursing Mothers: It is not known whether this
drug is excreted in human milk. Because many
drugs are excreted in human milk, caution should
be exercised when this product is administered to
a nursing woman.
Pediatric Use: Safety and effectiveness in children
under the age of 12 years have not been established.
ADVERSE REACTIONS: Reports of irritation and
hypersensitivity to sodium sulfacetamide are
uncommon. The following adverse reactions,
reported after administration of sterile ophthalmic
sodium sulfacetamide, are noteworthy: instances of
Stevens-Johnson syndrome and instances of local
hypersensitivity which progressed to a syndrome
resembling systemic lupus erythematosus; in one

case a fatal outcome was reported (see WARNINGS).

OVERDOSAGE: The oral LD50 of sulfacetamide in
mice is 16.5 g/kg. In the event of overdosage,
emergency treatment should be started immediately.
Manifestations: Overdosage may cause nausea
and vomiting. Large oral overdosage may cause
hematuria, crystalluria and renal shutdown due to
the precipitation of sulfa crystals in the renal
tubules and the urinary tract. For treatment, contact
your local Poison Control Center or your doctor.
DOSAGE AND ADMINISTRATION: Wash affected
areas with this product once or twice daily or as
directed by a physician. Moisten skin and
cleansing pad with water. Work pad into full lather
and massage gently into skin for 10 to 20
seconds, rinse thoroughly and pat dry. Discard pad
in refuse container. If drying occurs, it may be
controlled by rinsing affected area sooner or using
product less frequently.
STORAGE: Store at 20C to 25C (68F to 77F),
excursions permitted between 15C and 30C
(between 59F and 86F). Brief exposure to
temperatures up to 40C (104F) may be tolerated
provided the mean kinetic temperature does not
exceed 25C (77F); however, such exposure
should be minimized.
NOTICE: Protect from freezing and excessive heat. The
product may tend to darken slightly on storage. Slight
discoloration does not impair the efficacy or safety of
the product. Keep dispensing container tightly closed.
Occasionally, a slight discoloration of fabric may
occur when an excessive amount of the product is
used and comes in contact with white fabrics. This
discoloration, however, presents no problem, as it
is readily removed by ordinary laundering without
bleaches.
HOW SUPPLIED: This product is supplied in the
following size(s):
30 count carton, NDC 0178-0640-30
60 count carton, NDC 0178-0640-60
To report a serious adverse event or obtain product
information, call 1-800-298-1087.
Manufactured for:
MISSION PHARMACAL COMPANY
San Antonio, TX 78230 1355

0640I.01
C01 Rev 007130

The object of this therapy is to achieve

AVA-14110

Dermatology Times

Clinical Analysis for Todays Skincare Specialists

In This Issue

August 2014

VOL. 35, NO. 8

CLINICAL 18

Single-dose tablet
effective for labial herpes
August 2014

New delivery system of established

drug increases efcacy

COSMETIC 28

Incorporating lasers

Volume 35 No. 8

How to ensure youre choosing wisely

ONCOLOGY 50

Managing locally
advanced BCC
Determining appropriate
treatment strategies

Clinical Analysis for Todays Skincare Specialists

BUSINESS 66

Insurance exchange,
ACO pressures mounting
Dermatologists face increasing
pressure to prove their value

August 2014

VOL. 35, NO. 8

Complement
or competitor?
Experts weigh in on the role for electronic surface
brachytherapy in the dermatologists office
Electronic surface brachytherapy uses a portable
machine (Xoft Axxent Electronic Brachytherapy
System; iCAD) about the size of a laser to generate
precise, accurately targeted doses of radiation applied
through an applicator placed directly on the skin.
Photos: Philip Werschler, M.D.

THE TAKEAWAY 88

Medication
adherence
As a primary factor impacting
treatment success, Steven
Feldman, M.D., discusses the
important role adherence plays
in patient management
FOLLOW US ONLINE:

DermatologyTimes.com
Clinical

Cutaneous drug
reaction diagnoses
require art, urgency
DermatologyTimes.com

John Jesitus | Senior Staff Correspondent

SUCCESSFULLY managing cutaneous drug

reactions requires including drug reactions in the differential diagnosis of most
cutaneous eruptions, and recognizing
severe reactions where treatment may
improve outcomes, an expert says.
Diagnosing cutaneous drug reactions is almost an art, says David R.
Adams, M.D., Pharm.D., professor of
dermatology at Penn State Hershey
Medical Center, Hershey, Pennsylvania. Usually its based on the clinical
appearance of the reaction and evaluation of the timing of medication administration. This can vary, depending on
the type of reaction.
DRUG REACTIONS see page 25

magenta
cyan
yellow
black

John Jesitus | Senior Staff Correspondent

Electronic surface brachytherapy allows dermatologists to offer patients another safe, effective
option for nonmelanoma skin cancer (NMSC),
many experts say. And if the specialty doesnt
seize the opportunity, they add, it might lose some
skin cancer treatments to radiation oncologists.
The appeal of electronic surface brachytherapy to the dermatology community is that
this is something performed in our offices
that has a cure rate, as best we understand it,
that approximates that of Mohs surgery, says
Wm. Philip Werschler, M.D., a dermatologist
in Spokane, Washington, and assistant clinical
professor of medicine/dermatology, University of
Washington School of Medicine, Seattle.
Electronic surface brachytherapy is also

patient- and physician-friendly, he says. The iCAD

Xoft Axxent Electronic Brachytherapy System was
cleared by the Food and Drug Administration in
2009 for the treatment of NMSC. Typical treatment
protocol using the system includes two treatments
weekly for four weeks, versus 25 to 40 treatments
total (three to five treatments weekly) with traditional radiotherapy, says Dr. Werschler, who offers
electronic surface brachytherapy for NMSC in his
office.
Traditional radiotherapy also suffers from an
image problem with respect to NMSC, he says.
Along with the inconvenience of visiting a cancer
center for months on end, Patients with skin
cancer dont see themselves as being sick. Theyre
BRACHYTHERAPY see page 59

ES474907_DT0814_CV1.pgs 07.29.2014 23:40

ADV

Others Promise.
Obagi Delivers.

Those who know, use Obagi

the #1 physician-dispensed skin care company 1
The brand most trusted by dermatologists and plastic surgeons1
Transformational systems and specialty products for all skin types

For more information call 1.800.636.7546 today.

www.obagi.com
Reference: 1. Professional Skin Care 2012: U.S. Market Analysis and Opportunities. Parsippany, NJ: Kline & Company, Inc.; 2013.
Except as otherwise indicated, all product names, slogans and other marks are trademarks of the Valeant family of companies. Distributed by OMP, Inc.
2014 Obagi Medical Products, Inc., a division of Valeant Pharmaceuticals North America LLC. DM/OBG/14/0035 04/14

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ES467154_DT0814_CV2_FP.pgs 07.18.2014 23:02

ADV

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ES474340_DT0814_003.pgs 07.29.2014 21:48

ADV

IN MEMORIAM

AUGUST 2014 DERMATOLOGYTIMES.COM

Susan R. Schell
July 25, 1956 - June 8, 2014

Dermatology Times editors accomplishments

speak volumes about character, quality of life

am taking some space this month to

pay tribute to a colleague and true
journalism professional. It is with a
heavy heart that I write to you about
the passing of Susan R. Schell. Susan
was the managing editor for Dermatology Times and its sister publication
Cosmetic Surgery Times for nearly a
decade.
She left abruptly in May 2012 after
being diagnosed with leukemia. She
fought a quiet but ver y strong and
deliberate battle, just as her personality
would lead you to believe she would.
Susan died Sunday, June 8 at only 57
years old. Too soon.

conferences and read publications like

this one to continue to learn and stay
up to date on how to best treat, manage
and care for your patients. And accomplishment is the result of your quest for
knowledge for the betterment of your
patients.
Susans quest resulted in a number
of contributions to her profession. She
won a number of awards for her work
within dermatology as well as for her
prior news coverage of city, state and
national education issues. She also
forged a path for women in newspaper
journalism when she joined the East
Liverpool-based Evening Review as the

She worked very hard to elevate the

publication and to package news in a
valuable and practical way, because she
understood that your dedication was to
your profession and your patients.
None of us is guaranteed a certain
number of days. While we cant control
the quantity of life years we receive, we
can certainly control the quality. We
can choose the contents of our lives
the experiences we have and the
achievements we strive for. Susan is a
true testament to a life well-lived.
She followed a path in the hope of
bettering lives through sharing information. She dedicated herself to the
ongoing study of those things that
were of great interest to her, much like
you all do every day. You chose a path
in medicine to better the lives of the
patients that seek your help. You attend

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newspapers first woman city editor,

something I learned only upon reading
her obituary. She was very humble in
her accomplishments; achievement
was merely the result of a way of being
for Susan.
She strived for excellence, accuracy
and, above all, honesty and fairness. In
her reporting days, she dug for the truth
and she presented the facts for others
to form their own judgments. In her
role as editor, she directed and molded
stories that aimed to enrich your knowledge base and to help you to best serve
your patients. She worked very hard to
elevate the publication and to package

news in a valuable and practical way,

because she understood that your dedication was to your profession and your
patients. And so her standards were
high for herself, for our writers and
for the staff. She stood by the Reporters
Creed and she never wavered in her
personal and professional ethics.
A student of life in every sense, Susan
was an avid reader and researcher. She
had a real passion for nutrition, natural
health practices and energy medicine.
She regularly studied these areas and
applied her knowledge to how she lived
her life.
Not many people know that Susan
had been diagnosed with progressive
multiple sclerosis that had, from all
accounts, appeared to have taken its
hold. This is something else I learned
more about as I talked with her family
after her passing. Her drive to learn
helped her to overcome the disease. Her
condition actually improved through
her perseverance to stay well.
Im sharing this with you so that you
may gain a better sense of the person
behind the name that you may have
interacted with during her time with
our publication. Susan was a smart and
dedicated woman with a restrained
but witty sense of humor. She followed
a path that was uniquely hers and she
shined. And isnt that what each of us
hopes for? To be satisfied that you were
true to your calling, you followed your
passion, and, in the end, you made a
difference.
Heather Onorati,
Content Channel Director,
Dermatology Times

ES474733_DT0814_004.pgs 07.29.2014 23:12

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ES473279_DT0814_005_FP.pgs 07.28.2014 20:19

ADV

EDITORIAL ADVISORY BOARD

AUGUST 2014 DERMATOLOGYTIMES.COM

insight & opinion from our advisory board leaders

Ronald G. Wheeland, M.D.
is a private practitioner
in Tucson, Ariz.

Evaluating the
realities of the
Affordable Care Act

here are no valid reasons, in my

opinion, that everyone should
not have access to high quality
healthcare. Sadly, due to corrupt
governments, geographic isolation, religious
and ethnic conflicts, poor economies, inadequate education, ineffective leadership
or a simple lack of will, much of the worlds
population has little or no access to healthcare. This is a gigantic problem with global
implications that has no simple solution.
If one chooses to focus attention only
on the industrialized countries of the world,
where most of these limitations to receiving
healthcare do not exist, we find the United
States is a very long way from the top in
providing high quality healthcare to all its
citizens. The reasons for this are numerous,
but all are ultimately unacceptable.
To try and give access to healthcare to
millions of uninsured Americans, Congress
and the president passed legislation that
led to the creation of the Affordable Care
Act (ACA). While it is still being implemented
and certain to continue evolving over
time, I believe it is fair to evaluate the early
successes and shortcomings of the ACA.
Number of people receiving care Despite
a less than officious start manifested by
extraordinary technical difficulties in getting
people signed up during the enrollment
period, it appears more Americans now
have health insurance coverage than before
ACA was enacted. This is an improvement,
but more than 13 percent of Americans still
remain without insurance. With a lot more
work still needing to be done to provide
healthcare coverage for these individuals, in
my arbitrary grading system, this category
would only receive a grade of incomplete.
Quality of care Merely having increased
access to healthcare doesnt necessarily
imply anything about the quality of that care
or the quality, training and number of physi-

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cians available to provide it. In fact, there

are disturbing reports of a huge looming
problem for both patients and specialty
physicians alike. This comes in the form of
a concerted effort by both the government
and some insurance companies, especially
the Medicare Advantage Plans, to reduce
the cost of treating patients by limiting
access to certain specialties, including
cardiology, nephrology and dermatology.
This is being accomplished by
narrowing the scope of the provider
networks and delisting physicians
without providing any explanation or reason.
In a broadcast fax to its members dated
June 23, 2014, the American College of
Mohs Surgeons released a letter stating
that to date, there are 20 states in which
either Humana or United Healthcare have
terminated physicians to create a narrower
network of physicians.
Furthermore, it seems those delisted
physicians were never accused of having
provided low quality care or had bad
outcomes. Rather, the actions appear to
be based entirely on reducing costs. If
increasing access to healthcare comes
at the cost of not being able to see certain
specialists, I believe this creates a twotiered system of healthcare, something Ive
always personally found reprehensible.
Individuals who can afford it will
purchase a more costly but higher quality
plan and maintain their access to physicians
of their choosing, including specialists. Individuals of lower economic means with less
expensive healthcare plans will likely lose
out on the option of seeing specialists in a
timely fashion.
When National Health Insurance was
adopted in England years ago, long waiting
periods developed for patients with certain
chronic diseases or disorders. As a result,
those with the necessary financial means

purchased their own private health insurance so they could be seen more rapidly by
the physician or specialist of their choosing.
This is the type of two-tiered system
Id like not to see in the United States. If
delisting of physicians to narrow the scope
of the provider network continues, my grade
for this component of ACA would be a D.
Higher deductibles In order to avoid
the tax penalty of $95 or 1 percent of an
individuals total taxable income for not
having enrolled in a health insurance plan
under ACA, some patients opted for a lower
cost plan with a high deductible. Many of
these patients failed to realize this and were
shocked to learn that when an unexpected
injury or illness occurs, they are responsible
for perhaps a sizeable portion of their care.
In some cases, the deductible may range
from $3,000 to $5,000. While this problem
may have been driven by the terms of the
ACA (since uninsured people had to get
insurance or pay a penalty), it should not be
blamed on this program since it truly was
one of those unintended consequences of
this legislation. The grade for this section
would therefore be non-credit or no grade.
Increased bureaucracy If you thought
HIPAA (Health Insurance Portability and
Accountability Act) and EHR (electronic
health records) were difficult and expensive
to implement, wait until you have to decide
which ACO (accountable care organization)
to become affiliated with and how to prove
that your practice provides efficient, effective, high-quality care at appropriate cost.
It seems inevitable with the push toward
value-based incentives that more effort will
be required to prove to your ACO the value
of a patient seeing you for dermatologic
care rather than someone else. If all those
werent enough new bureaucratic hurdles to
clear, wait for the creation and implementation of the new IPAB (Independent Payment
Advisory Board) that will determine how to
reduce Medicare costs without impacting
quality of care. My grade for increased
bureaucracy under ACA would be a D.
Providing healthcare of high quality
at a reasonable cost is not only incredibly difficult but also extremely complex.
Having partially accomplished the goal of
increasing the number of Americans with
health insurance coverage, it is time to take
substantial, thoughtful corrective action to
eliminate the errors described above. Otherwise, these goals will never be met and our
patients will continue to suffer the consequences. DT

Ronald G. Wheeland, M.D.

ES467126_DT0814_006.pgs 07.18.2014 20:21

ADV

Skin is as important to us as it
is to you. So at Celgene, were
bringing our scientific expertise
andinnovative thinking to dermatology.
Its our commitment to help you help
your patients.

2014 Celgene Corporation 01/14 USII-CELG130017b

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ES467135_DT0814_007_FP.pgs 07.18.2014 23:01

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NEWS EAGLE
LEGAL

UPDATE

AUGUST 2014 DERMATOLOGYTIMES.COM

David Goldberg, M.D., J.D.,

is director of Skin Laser &
Surgery Specialists of New York
and New Jersey; director of laser
research, Mount Sinai School of
Medicine; and adjunct professor
of law, Fordham Law School.

Teledermatology
fraught with
liability issues

r. Cali, a practicing dermatologist in California, has spent the

last several years looking for
new revenues sources. He has
a very active interactive website and associated blog. Because of this he receives
hundreds of questions from potential
patients all over the country.
Four years ago, before he began to
charge for email consults, he received
a photo from Kentucky of a classic blue
nevus. He told the patient the lesion was
nothing to worry about. It turned out he
was wrong. The patient had a rare malignant blue nevus and died from metastatic
malignant melanoma 18 months later.

Telemedicine
consulting may not
be covered by your
malpractice insurer.
Ultimately the deceased patients
estate sues for negligence, wrongful
death and practicing telemedicine without a license in Kentucky.
Dr. Cali is horrified and seeks legal
advice. Should he be worried?
Telemedicine is a term that covers
any use of electronic communication
technology to convey medical information. It can be as basic as seeking a
consultation or as advanced as robotic
surgery. Teleradiologists and telepathologists use electronic communication to
send radiographs and specimen images

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for diagnostic or consultation purposes.

Teledermatology can be practiced in
the role of a consultant or as a seeker of
consultation. However, this practice is
fraught with liability issues.

stands and obtain coverage in any state

with patients affected by your consulting
if you do not have that protection. (ii)
Does your carrier cover you for telemedicine practice? Telemedicine consulting
may not be covered by your malpractice insurer and you may need to obtain
surplus lines coverage.

Are you exceeding

the license granted
by your own
state? If so, you
can be subject to
disciplinary action.

Licensure

Negligence liability

(i) Are you exceeding the license granted

by your own state? If so, you can be
subject to disciplinary action in your
own state if you use your license inappropriately as a predicate to practice
telemedicine. So you must determine if
your state permits you to act as a telemedicine. (ii) Are you engaging in the
unlicensed practice of medicine in other
states? There is no national consensus
on what states demand from physicians
located outside their borders and are
practicing telemedicine within any one
state. Some states demand full licensure, some offer restricted licenses for
telemedicine, and some offer licensing
by endorsement under reciprocity
agreements with neighboring states.
Despite the wide range of options,
there is a common thread to keep in mind:
if there is a regular, ongoing practice of
telemedicine in the state (as opposed to
an occasional consultation) the state will
want some degree of licensure. A physician who lacks such licensure can be
subject to prosecution for the unlicensed
practice of medicine.

(i) Can a medical malpractice action

be brought in the setting of telemedicine? Yes. (ii) Where can the action be
brought? The issue of forum shopping
comes into play if the doctor provided
the telemedicine service in a state
different from where the patient lives.
Most jurisdictions will permit a resident
to bring a lawsuit where the patient
received care or where the defendant
physicians office is located.
Telemedicine obviously expands the
scope of venue exposure. The plaintiff can
bring the telemedicine consultant into a
court in his state. A state may also require
venue. For example, Montana and North
Carolina both require that any medical
malpractice claims by their residents
that are based on telemedicine must be
brought within their state. A physician who
practices in a state with a short statute of
limitations should not assume that time
limit will apply if he is sued for telemedicine
consult. Different states also take different
approaches to the standard of care.
Some use a national standard and some
use a local one. The consulting telemedicine physician should therefore become
acquainted with the standards used in the
states they extend their practice to.
In the end, Dr. Cali should be
concerned. The fact that he did
not charge the now-deceased
patient will be no defense. DT

Insurance coverage
(i) Most malpractice policies specifically
exclude coverage for unlicensed activities. Some states require insurers to cover
work that extends beyond state borders
and some do not. Know where your state

ES467125_DT0814_008.pgs 07.18.2014 20:21

ADV

Barrier Protection
for the Ages

RxOnly

ELETONE CREAM

NOW AVAILABLE IN

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Contains two100-gram tubes of Eletone Cream

The TwinPack offers a supply of 2 tubes as an
added convenience and for greater coverage of
affected areas during the seasons when atopic
dermatitis tends to flare most. With one prescription,
patients can receive twice as much therapy for
the same pharmacy co-pay as with the single tube.

ELETONE CREAM
Nonsteroidal Atopic Dermatitis Therapy

PRODUCT DESCRIPTION:

Eletone Cream is a non-steroidal, lipid-rich,

fragrance free emulsion formulated with Hydrolipid Technology for the
management and relief of burning, itching, and redness associated with various
types of dermatoses. There are no restrictions on age or duration of use and the
product has a low potential for irritation.

INDICATIONS FOR USE:

Eletone Cream is indicated for the management and

relief of burning, itching, and redness associated with various types of dermatoses,
including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis
(post-radiation treatment).

CONTRAINDICATIONS: THIS PRODUCT SHOULD NOT BE USED DURING THE

PERIOD OF TIME WHEN RADIATION TREATMENT IS OCCURRING BECAUSE OF THE
INCREASED RISK OF SKIN TOXICITY WHEN RADIATING THROUGH PETROLATUM AND
OIL. Eletone Cream is contraindicated in patients with a known hypersensitivity
to any of the components of the formulation.

PRECAUTIONS: Eletone Cream is for external use only. Eletone Cream

does not contain a sunscreen and should always be used in conjunction
with a sunscreen in sun exposed areas.

INSTRUCTIONS FOR USE:

Apply liberally to the affected areas three

times daily or as needed. If skin is broken, cover Eletone Cream with a
dressing of choice.

INGREDIENTS: Eletone Cream contains petrolatum, purified water,

mineral oil, cetostearyl alcohol, ceteth-20, citric acid, sodium citrate,
propylparaben, and butylparaben.
HOW SUPPLIED:

Eletone Cream is available in a 100 gram tube

NHRIC 0178-0368-01.
Store at 25C (77F); excursions permitted to 15-30C (59-86F)
[see USP Controlled Room Temperature].

CAUTION:

Rx only. Federal law restricts this device

to sale by or on the order of a physician.
Copyright 2014 Mission Pharmacal Company. All rights reserved.

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ES473267_DT0814_009_FP.pgs 07.28.2014 20:18

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ADVANCES

10

AUGUST 2014 DERMATOLOGYTIMES.COM

PMMA in collagen effective

for clearing acne scars
Journal of the American Academy of Dermatology
July 2014

http://bit.ly/PMMAclearsacnescars

POLYMETHYLMETHACRYLATE
(PMMA) microspheres in collagen
are effective for treating atrophic acne
scars, results of a recent study suggest.
Investigators from Suneva Medical
gave 147 patients w ith at least four
moderate-to-severe rolling atrophic
acne scars eit her A rteFill (PMM Acollagen, Suneva) or saline injections.
The patients received up to two treatment sessions and were followed up
for six months, according to the study.
Investigators determined efficacy with
a validated rating scale for each scar.

Sixty-four percent of patients treated

with ArteFill demonstrated success,
compared to 33 percent of the control
subjects (P=0.0005). There were no
significant differences in safety or efficacy
between genders, darker skin types or older
age groups, researchers noted. Adverse
events were generally mild and reversible.
PM M A-col lagen demonst rates
substantial effectiveness in the treatment
of atrophic acne scars of the face while
maintaining an excellent safety profile,
study authors concluded. Further followup should be undertaken to demonstrate
longer-term benefit and safety.
The Food and Drug Administration
approved ArteFill in 2006 for the correction of nasolabial folds. DT

Arthritis drug spurs hair

regrowth in alopecia patient
Journal of Investigative Dermatology
June 2014
www.nature.com/jid/journal/vaop/naam/pdf/jid2014260a.pdf

THE RHEUMATOID ARTHRITIS

drug tofacitinib citrate allowed a
patient with alopecia universalis to
grow a full head of hair, a Yale University
dermatologist says.
The 25-year-old male patient was
referred to the department of dermatology at Yale School of Medicine for
treatment of psoriasis. The patient had
also been diagnosed with but never
been treated for alopecia universalis,
leaving him hairless everywhere but
in the psoriasis plaques on his head,
according to a news release. Brett A. King,
M.D., assistant professor of dermatology
at Yales School of Medicine, thought
it possible to treat both diseases with
tofacitinib citrate, which the Food and
Drug Administration has approved for
the treatment of rheumatoid arthritis.
The drug has been used successfully for
treating psoriasis in humans and in trials
has reversed alopecia areata in mice.

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The patient was given 10 mg daily for

two months, after which his psoriasis
showed some improvement. In addition, the man grew scalp and facial
hair for the first time in seven years.
After three more months of 15 mg daily
treatments, the patient had completely
regrown scalp hair as well as eyebrows,
eyelashes, armpit and other hair all
of which he lacked before the treatments started.
This is a huge step forward in the
treatment of patients with this condition, Dr. King said in the statement.
While its one case, we anticipated the
successful treatment of this man based
on our current understanding of the
disease and the drug. We believe the
same results will be duplicated in other
patients, and we plan to try.
Tofacit inib appears to spur hair
reg row t h i n a lopec ia u n iver sa l i s
patients by blocking immune-system
at t ac k s on h a i r fol l ic le s t h at a re
prompted by the disease. Dr. King and
his colleagues are proposing a clinical
trial to test a tofacitinib-based cream for
treating alopecia areata. DT

FDA grants
orphan drug
status for
congenital
ichthyosis
treatment

THE FOOD AND DRUG Administration has granted orphan drug designation to Galdermas trifarotene molecule
for the treatment of congenital ichthyosis.
As a result, Galderma officials say the
company plans to implement a clinical
development plan to explore new treatment options for other rare skin diseases
such as cutaneous T-cell lymphoma and
Gorlin syndrome.
The or pha n dr ug desig nat ion is
reserved for drugs and biologics that
are intended for the effective treatment,
diagnosis or prevention of rare disorders
that affect fewer than 200,000 people in
the United States or that affect more than
200,000 people but are not expected to
generate enough revenue to cover development and marketing costs.
Given the burden of congenital ichthyosis and the lack of effective and easy-touse treatments, this is a condition which
is very difficult to live with, Galderma
President and CEO Humberto C. Antunes
said in a news release. Galdermas objective is therefore not only to provide an efficient and safe medical solution to alleviate
the symptoms of the disease, but also to
improve patients quality of life.
The trifarotene molecule is a selective agonist of the gamma retinoic
acid receptor (RAR-gamma), which is
currently in clinical development for use
in more common dermatological conditions, according to the company. The
drugs retinoid functionality and keratolytic properties make it a potentially viable
treatment for lamellar ichthyosis.
Galderma has initiated the program
for investigating the treatment of lamellar
ichthyosis with trifarotene and is currently
working in collaboration with regulators
to implement a clinical development plan.
The estimated domestic prevalence of
lamellar ichthyosis is in the range of one
per 150,000 persons.DT

ES468579_DT0814_010.pgs 07.23.2014 04:31

ADV

A BREAKTHROUGH
SPOT TREATMENT FOR
COLD SORE OUTBREAKS

www.

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.com

ES467134_DT0814_011_FP.pgs 07.18.2014 23:01

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ADVANCES

12

AUGUST 2014 DERMATOLOGYTIMES.COM

FDA approves new

drug for skin infections

THE FOOD AND DRUG Administration has approved Sivextro (tedizolid

phosphate, Cubist Pharmaceuticals) for
the treatment of acute skin infections.
Sivextro an intravenous and oral drug
that is for adult patients with acute bacterial skin and skin structure infections
(ABSSSI) caused by certain bacteria,
including Staphylococcus aureus, certain
Streptococcus species and Enterococcus
faecalis, according to a news release.
The drugs efficacy and safety were
examined in two clinical trials of 1,315
patients with ABSSSI. Patients were
randomly assigned to receive Sivextro or
the antibacterial drug linezolid.
These studies demonstrated that
Sivextro 200 mg administered once daily
for six days was statistically noninferior
to 600 mg of linezolid taken twice a day
for 10 days, the company stated in a
news release.
Sivextro is administered once daily
and provides a six-day course of therapy.
It is an oxazolidinone w ith in vitro
activity against susceptible Gram-posi-

tive pathogens such as methicillin-resistant Staphylococcus aureus (MRSA),

according to the company.
The Sivextro application was designated as a qualified infectious disease
product (QIDP) due to its treatment of
serious and life-threatening infections,
and thus received from the FDA an
expedited review. The designation allows
Sivextro to qualify for an additional five
years of marketing exclusivity on top of
some of the exclusivity periods already
given by the Food, Drug and Cosmetic
Act, according to the FDA.
Sivextro provides physicians with
flexibility to transition patients from I.V.
to oral treatment as required, Michael
Bonney, Cubist chief executive officer,
stated in the news release. The oral
option provides opportunity for outpatient care, which could reduce the
need for costly hospitalization.
In May, the FDA approved another
drug, Dalvance (dalbavancin, Durata
Therapeutics), also for the treatment
of ABSSSI. DT

FDA grants expanded

use for Lymphoseek

LYMPHOSEEK is now approved

by the Food and Drug Administration to help clinicians determine
whether squamous cell carcinoma
has spread to a pat ients head and
neck region.
Ly mpho s e e k (t e c h ne t iu m 9 9 m
t i l m a n o c e p t i n j e c t i o n , Na v i d e a
Biopharmaceuticals) was approved in
2013 for use in identifying lymph nodes
closest to primary tumors in patients
with melanoma or breast cancer. The
newest FDA approval allows clinicians
to use Lymphoseek to guide sentinel
lymph node biopsy in patients who
have squamous cell carcinoma of the
oral cavity. It is the only FDA-approved
rad iopha r maceut ic a l appl ic at ion

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for sentinel ly mph node detection,

according to a news release.
Lymphoseek w ill be immediately available with the existing reimbursement codes for this expanded
p o p u l a t i o n o f c a n c e r p a t i e n t s ,
Michael Goldberg, M.D., Nav ideas
interim chief executive officer, said in
the statement.
The expanded approval came after
a prospective phase 3 study demonstrated that Lymphoseek had a statistically significant ability to correctly
ident i f y pat ient s w it h pat holog ypositive ly mph nodes compared to
multiple level lymph node dissection
and pathology assessment, according
to the company. DT

FDA clears
Kerydin topical
solution for
onychomycosis
of the toenails

THE FOOD AND DRUG ADMINISTRATION has approved tavaborole

(Kerydin, Anacor Pharmaceuticals)
topical solution 5 percent, which is the
first oxaborole antifungal approved for
the topical treatment of onychomycosis
caused by Trichophyton rubrum or Trichophyton mentagrophytes. Nail debridement
is not necessary, according to Anacor.
Due to its topical application, tavaborole has low systemic absorption and
has not demonstrated systemic side
effects. The FDA determined the efficacy
and safety of tavaborole based on two
multicenter, double-blind, randomized
trials involving 1,194 patients. The trials
compared the drug with topical vehicles
carrying an active dermatological ingredient.
Tavaborole or vehicle was applied
once daily for 48 weeks in patients with
20 to 60 percent clinical involvement of
the target toenail, without dermatophytomas or lunula (matrix) involvement.
Assessments were made at 52 weeks
after 48 weeks of treatment. A complete
cure defined as a completely clear nail
(0 percent clinical involvement), plus
mycologic cure, consisting of a negative
KOH test and a negative culture was
observed in 6.5 percent of patients using
the product in trial 1 and 9.1 percent of
those in trial 2 compared with 0.5 and
1.5 percent, respectively, of patients
applying the vehicle.
Seconda r y end poi nt s i ncluded
complete or almost complete cure
(le s s t h a n or e qu a l to 10 perc ent
affected target toenail area involved
plus mycological cure). A total of 15.3
and 17.9 percent of patients treated
with tavaborole achieved this endpoint,
compared to 1.5 and 3.9 percent of
patients treated with vehicle in the first
and second trials, respectively. DT

ES468580_DT0814_012.pgs 07.23.2014 04:31

ADV

Cloderm Cream for

dry, cracked, and
inamed skin

CLODERM CREAM AND ITS AUTHORIZED GENERIC

MAY EXPAND PATIENT ACCESS BY DELIVERING:
P Enhanced formulary access
P Fewer insurance challenges
P Reduced pharmacy callbacks
Cloderm Cream demonstrated better
skin hydration and moisturization than both
Locoid Lipocream (hydrocortisone butyrate, 0.1%)
and Locoid Lotion (hydrocortisone butyrate, 0.1%).1,2

Same formulation
Same manufacturer
Learn more at www.clodermcream.com

Indication and Important Safety Information

Cloderm Cream and Clocortolone pivalate Cream, 0.1% are indicated
for the relief of the inammatory and pruritic manifestations of
corticosteroid-responsive dermatoses. The most common adverse
events with Cloderm Cream and Clocortolone pivalate Cream, 0.1%
include burning, itching, irritation, dryness, and folliculitis. Cloderm
Cream and Clocortolone pivalate Cream, 0.1% are contraindicated in
patients who are hypersensitive to any of the ingredients of these
products. As with all topical corticosteroids, systemic absorption
can produce reversible HPA-axis suppression.
Please see Brief Summary of prescribing information below.

Not a cookie-cutter
topical steroid

Locoid Lipocream and Locoid Lotion are registered trademarks of Astellas Pharma Europe B.V. licensed to Onset Dermatologics
References: 1. Data on le. Study #CDC1303. Bridgewater, NJ: Promius Pharma, LLC; 2013.
2. Data on le. Study #CDC1304. Bridgewater, NJ: Promius Pharma, LLC; 2013.
Cloderm is a trademark of Coria Laboratories, Ltd. 2014 Promius, Pharma, LLC. All rights reserved. CDM-0414-106

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ES473269_DT0814_013_FP.pgs 07.28.2014 20:18

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RxOnly

5. Parents of pediatric patients should be advised not to use tight-tting diapers or plastic pants on
a child being treated in the diaper area, as these garments may constitute occlusive dressings.
Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression:
Urinary free cortisol test
ACTH stimulation test

FOR TOPICAL DERMATOLOGIC USE ONLY

NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.
WARNING: KEEP OUT OF REACH OF CHILDREN

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been
performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

DESCRIPTION: Cloderm Cream 0.1% contains the medium potency topical corticosteroid,
clocortolone pivalate, in a specially formulated water-washable emollient cream base consisting of
puried water, white petrolatum, mineral oil, stearyl alcohol, polyoxyl 40 stearate, carbomer 934P,
edetate disodium, sodium hydroxide, with methylparaben and propylparaben as preservatives.

Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when

administered systemically at relatively low dosage levels. The more potent corticosteroids have
been shown to be teratogenic after dermal application in laboratory animals. There are no adequate
and well-controlled studies in pregnant women on teratogenic effects from topically applied
corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the
potential benet justies the potential risk to the fetus. Drugs of this class should not be used
extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Chemically, clocortolone pivalate is

9-chloro-6-uoro-11,
21-dihydroxy-16 methylpregna-1,
4-diene-3, 20-dione 21-pivalate.
Its structure is as follows:

CLINICAL PHARMACOLOGY:
Topical corticosteroids share anti-inammatory, antipruritic and vasoconstrictive actions.
The mechanism of anti-inammatory activity of the topical corticosteroids is unclear. Various
laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies
and/or clinical efcacies of the topical corticosteroids. There is some evidence to suggest that a
recognizable correlation exists between vasoconstrictor potency and therapeutic efcacy in man.
Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined
by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive
dressings.
Topical corticosteroids can be absorbed from normal intact skin. Inammation and/or other disease
processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase
the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable
therapeutic adjunct for treatment of resistant dermatoses.
(See DOSAGE AND ADMINISTRATION).
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic
pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma
proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then
excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted
into the bile.
INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inammatory
and pruritic manifestations of corticosteroid-responsive dermatoses.
CONTRAINDICATIONS: Topical corticosteroids are contraindicated in those patients with a history
of hypersensitivity to any of the components of the preparation.
PRECAUTIONS: General: Systemic absorption of topical corticosteroids has produced reversible
hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushings syndrome,
hyperglycemia, and glucosuria in some patients.
Conditions which augment systemic absorption include the application of the more potent steroids,
use over large surface areas, prolonged use, and the addition of occlusive dressings.
Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface
area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis
suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is
noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or
to substitute a less potent steroid.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of the
drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental
systemic corticosteroids.
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more
susceptible to systemic toxicity.
(See PRECAUTIONS-Pediatric Use).
If irritation develops, topical corticosteroids should be discontinued and appropriate therapy
instituted.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative
results.

Nursing Mothers: It is not known whether topical administration of corticosteroids could result
in sufcient systemic absorption to produce detectable quantities in breast milk. Systemically
administered corticosteroids are secreted into breast milk in quantities not likely to have deleterious
effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are
administered to a nursing woman.
Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroidinduced HPA axis suppression and Cushings syndrome than mature patients because of a larger
skin surface area body weight ratio.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushings syndrome, and intracranial
hypertension have been reported in children receiving topical corticosteroids. Manifestations
of adrenal suppression in children include linear growth retardation, delayed weight gain, low
plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial
hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Administration of topical corticosteroids to children should be limited to the least amount
compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with
the growth and development of children.
ADVERSE REACTIONS:
The following local adverse reactions are reported infrequently with topical corticosteroids, but
may occur more frequently with the use of occlusive dressings. These reactions are listed in an
approximate decreasing order of occurrence:
Burning, Itching, Irritation, Dryness, Folliculitis, Hypertrichosis, Acneiform eruptions,
Hypopigmentation, Perioral dermatitis, Allergic contact dermatitis, Maceration of the skin,
Secondary infection, Skin atrophy, Striae, Miliaria.
OVERDOSAGE:
Topically applied corticosteroids can be absorbed in sufcient amounts to produce systemic effects
(see PRECAUTIONS).
DOSAGE AND ADMINISTRATION:
Apply Cloderm (clocortolone pivalate) Cream 0.1% sparingly to the
affected areas three times a day and rub in gently.
Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.
If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
HOW SUPPLIED:
Cloderm (clocortolone pivalate) Cream 0.1% is supplied in 30 gram and 75 gram pump bottles, 45
gram and 90 gram tubes.
30 gram pump bottle
75 gram pump bottle
45 gram tube
90 gram tube

NDC-67857-804-30
NDC-67857-804-51
NDC-67857-804-45
NDC-67857-804-90

STORAGE:
Store Cloderm Cream between 15 and 30 C (59 and 86 F).
Avoid freezing.
Distributed by:

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial

agent should be instituted. If a favorable response does not occur promptly, the corticosteroid
should be discontinued until the infection has been adequately controlled.
Information for the Patient: Patients using topical corticosteroids should receive the following
information and instructions:
1. This medication is to be used as directed by the physician. It is for external use only. Avoid
contact with the eyes.
2. Patients should be advised not to use this medication for any disorder other than for which it was
prescribed.

www.promiuspharma.com
Promius Pharma, LLC
200 Somerset Corporate Blvd., Floor 7, Bridgewater, NJ 08807
Cloderm is a trademark of Coria Laboratories, Ltd.
Manufactured by:
DPT LABORATORIES, LTD.
San Antonio, Texas 78215

3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be
occlusive unless directed by the physician.
4. Patients should report any signs of local adverse reactions especially under occlusive dressing.

black

Issued 0711

004158

ES473280_DT0814_014_FP.pgs 07.28.2014 20:19

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ADVANCES

AUGUST 2014 DERMATOLOGYTIMES.COM

Secukinumab effective
for treating plaque psoriasis
New England Journal of Medicine
July 2014

http://bit.ly/secukinumab

SECUK INUM A B (NOVA RT IS)

is a n ef fect ive t reat ment for
moderate-to-severe plaque psoriasis,
according to the results of two large
phase 3 clinical trials.
Secukinumab is a laboratory-engineered antibody that targets interleukin17A, a pro-inflammatory protein linked
to psoriasis.
In one trial, doctors randomly administered the injectable to two-thirds of the
738 psoriasis patients involved. They
received a weekly dose of either 300 mg
or 150 mg for five weeks, then every four
weeks thereafter. The remaining third
received a placebo.
Improvements of 75 percent on the
Psoriasis Area and Severity Index (PASI
75) were seen at three months in 81.6
percent of the 300 mg patients, and in
71.6 percent of the 150 mg group. Only 4.5
percent of those randomized to placebo
demonstrated that kind of improvement.
In the second study, doctors administered eit her 300 mg or 150 mg of
secukinumab to half of a pool of 1,306

psoriasis patients, as in the first trial.

Another quarter received etanercept
(Enbrel, Amgen), one of the top treatments for psoriasis. The remaining
quarter received a placebo. PASI 75
responses at three months were reported
for 77.1 percent of the 300 mg group, 67
percent of the 150 mg patients, 44 percent
of the etanercept group and 4.9 percent
of the placebo patients.
Within 12 weeks, 80 percent of patients
who received 300 mg of secukinumab
experienced a 75 percent improvement in
their psoriasis symptoms, compared with
one of every 20 patients receiving placebo.
About 59 percent of patients receiving the
higher dose of secukinumab reported a
90 percent improvement in symptoms,
and nearly 30 percent said their psoriasis
cleared completely.
This is great news for psoriasis
patients, co-author Mark Lebwohl, M.D.,
chairman of the department of dermatology at Mount Sinais Icahn School of
Medicine in New York, tells Dermatology
Times. Secukinumab achieves levels of
clearing not reported in the past even
in patients who failed other biologics and
systemic therapies. It is a breakthrough in
the treatment of psoriasis. DT

Duration of antibiotic use

for acne decreasing slowly
Journal of the American Academy of Dermatology
July 2014

http://bit.ly/acneantibioticsslow

PH Y SICI A NS a re pre s c r ibi ng

ant ibiot ics for acne for shorter
durations, but almost one-fifth of antibiotic therapies for acne still exceed
six months, according to results of a
recent study.
For the retrospective cohort study,
researchers with Penn State Milton
S. Hershey Medical Center, Hershey,
Pennsylvania, reviewed data from the
MarketScan Commercial Claims and
Encounters database to examine the
duration of antibiotic therapy among
31,6 3 4 c ou r s e s pr e s c r ib e d . Mo s t
courses (93 percent) lasted for less than

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nine months. Mean course duration

was 129 days, according to the study.
Nea rly 58 percent of t reat ment
courses did not include concomitant
topical retinoid therapy. The mean
du r at ion (95 p erc ent c on f idenc e
inter val) w it h and w it hout topical
retinoid use was 133 days (131.5-134.7)
and 127 days (125.4-127.9), respectively. The mean excess direct cost of
antibiotic treatment for more than six
months was $580.99 per person.
St udy aut hors noted t hat wh i le
t he du r at ion of a nt i biot ic u s e i s
decreasi ng compa red to prev ious
data, 5,547 (17.3 percent) courses
exceeded six months, highlighting
an opportunit y for reduced antibiotic use. DT

15

Melanoma
combination
therapy shows
promising
results

GENENTECH HAS ANNOUNCED

t hat its phase 3 coBR IM st udy
eva luat ing t he safet y and ef f icac y
o f R o c h e s i n v e s t i g a t i o n a l d r u g
cobi met i n ib i n combi nat ion w it h
Zelboraf (vemurafenib) has met its
primary endpoint.
The study tested the combination in
495 patients with BRAF V600 advanced
or metastatic melanoma.
According to a Genentech news
release, cobimetinib is designed to
block the activ it y of MEK, one of a
series of cellular proteins that make
up a sig na ling pat hway t hat helps
regulate cell division and survival.
Cobi met i n ib bi nd s to M E K w h i le
Z e l b or a f b i nd s t o mu t a nt BR A F,
another protein on the pathway, to
interrupt abnormal signaling that can
cause tumors to grow.
T he st ud y demon st r ate d, i n a
randomized fashion, that the investigational MEK inhibitor cobimetinib,
used in combinat ion w it h Roches
BR A F i n h ibitor Z elb or a f, help e d
patients w ith previously untreated
BR A F V600 mutat ion-posit ive
advanced melanoma live significantly
longer w it hout t heir disease worsening, compared to Zelboraf alone,
Omid Hamid, M.D., coBRIM investigator and chief of research/immunooncolog y at T he A ngeles Cl i n ic &
Research Institute in Los A ngeles,
tells Dermatology Times. Advances
in the combination of targeted agents
i n mela noma hold t he prom ise of
improved survival.
Dr. Ha m id say s adver se e vent s
were consistent with those observed
in a previous study of the combination, adding that full results will be
presented at an upcoming meeting.
Genentech plans to submit the data
to the Food and Drug Administration
for potential approval. DT

ES468581_DT0814_015.pgs 07.23.2014 04:31

ADV

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936-1080

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2014 Novartis

5/14

XDP-1301059

ES467168_DT0814_016_FP.pgs 07.18.2014 23:03

ADV

IM TIRED OF BEING STARED AT. BUT WORSE,

I DONT EVEN WANT TO SEE MYSELF.
Many patients with moderate to severe psoriasis (PsO)
have trouble expressing how theyre doing. You
probably have patients in your practice who still suffer
from embarrassment, poor self-image, and social isolation
but arent talking to you about it.1-4

But with just 1 revealing question, you can uncover the

dissatisfaction your patients may have trouble expressing
and help make a real difference in managing their PsO.

MAKE A CONNECTION. MAKE A DIFFERENCE.

Find out how you can help at PsOmuchmore.com
References: 1. Data on le. Kantar Health 2013. Novartis Pharmaceuticals Corp; 2014. 2. Gupta MA, Gupta AK, Watteel GN. Perceived deprivation
of social touch in psoriasis is associated with greater psychologic morbidity: an index of the stigma experience in dermatologic disorders. Cutis.
1998;61(6):339-342. 3. Schmid-Ott G, Jaeger B, Kuensebeck HW, Ott R, Lamprecht F. Dimensions of stigmatization in patients with psoriasis
in a Questionnaire on Experience with Skin Complaints. Dermatology. 1996;193(4):304-310. 4. Armstrong AW, Schupp C, Wu J, Bebo B. Quality
of life and work productivity impairment among psoriasis patients: ndings from the National Psoriasis Foundation survey data 2003-2011.
PLoS One. 2012;7(12):e52935.

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ES467165_DT0814_017_FP.pgs 07.18.2014 23:03

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18

CLINICAL DERMATOLOGY

AUGUST 2014 DERMATOLOGYTIMES.COM

PROCESS OF ACNE
22 Insights
indicate new
mechanisms by which
bacteria induce lesions

Single-dose tablet
efective for labial herpes
Louise Gagnon | Staff Correspondent

QUICK READ

Houston A new delivery system

A new form of acyclovir, an

established form of treatment for
herpes labialis that brings larger
clinical beneft to patients, has
been approved by the FDA and
is scheduled to be commercially
available this year.

of an old drug designed to treat herpes

labialis resulted in fewer recurrences
of next herpes episodes, shorter
durations of episodes, and increased
incidence of blocked episodes.
We found that a drug (acyclovir)
that has been around for 30 years
was quite safe and effective in a new
route, says Stephen Tyring, M.D.,
Ph.D., principal investigator of a phase
3 double-blind, placebo-controlled
trial on Sitavig (50 mg acyclovir,
BioAlliance Pharma), a mucoadhesive
buccal tablet that uses a proprietary
technology that effectively delivers a
single low dose of acyclovir to treat
labial herpes. The reduction of subsequent (herpes) outbreaks is thought
to be but not known to be due to the
reduction of viral load.

Quotable
One of our challenges
moving forward is to
try to assess the relative
importance of the
various cytokines
involved in acne.
Diane Thiboutot, M.D.
Hershey, Pa.

On mechanisms of acne
See story, page 22

The key is milk

protein concentrate
in the formulation,
which facilitates the
tablet to adhere to
the gum.
Pierre Attali, M.D., M.Sc.
Paris

The Food and Drug Administration

approved Sitavig in 2013, and with a
commercial launch scheduled for this
year, it will be available for patients
in the United States.
Attacking the herpes simplex virus
(HSV), the most widely spread virus in
the herpes family of viruses, the drug met
the primary endpoint of shortening an
outbreak if an outbreak did occur when
it was applied during the prodrome, says
Dr. Tyring, a clinical professor of dermatology at the University of Texas Health
Science Center, Houston.
REDUCING OUTBREAKS

While the drug has optimal efficacy

when applied during the prodromal
phase, it did also reduce the number
of full-blown outbreaks when the
drug was applied subsequent to the
prodromal phase, he says.
HERPES LABIALIS see page 21

DTExtra
Content related to dermatology and dermatologic
conditions is widely available on YouTube, but
identifying sources for some of the content remains
a challenge, according to results of a recent study.
The study, conducted by University of Colorado
Cancer Center, Aurora, Colo., examined the type of
content related to dermatology found on YouTube.
Under the search term dermatology, 45 percent of
the content was educational, while 20 percent was
clinical demonstrations by dermatologists. Of the
total number of videos, 35 percent were uploaded
by or included an M.D./D.O./Ph.D. in dermatology
or another specialty or field, researchers found.
READ MORE: DERMATOLOGYTIMES.COM/YOUTUBEVIDEOS

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ES467452_DT0814_018.pgs 07.21.2014 20:16

ADV

ONE TOUGH SPRAY

A super-potent spray for moderate to severe plaque psoriasis

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BASELINE LEG

AFTER 4 WEEKS OF TREATMENT

Erythematous, scaling plaques on anterior left leg.

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Topicort Topical Spray is a topical corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.
Important Safety Information
t


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is not recommended.
1. Data on le, Taro Pharmaceuticals U.S.A., Inc.

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See brief summary of Prescribing Information on reverse side.

2014 Taro Pharmaceuticals U.S.A., Inc.
TaroPharma and Topicort are registered trademarks of Taro Pharmaceuticals U.S.A., Inc.

AD100-0036

June 2014

ES465596_DT0814_TARO1_FP.pgs 07.15.2014 20:41

ADV

TOPICORT (desoximetasone) Topical Spray, 0.25%

3Y
0OMZ
BRIEF SUMMARY
1 INDICATIONS AND USAGE
Topicort Topical Spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age
or older.
4 CONTRAINDICATIONS
None
5 WARNINGS AND PRECAUTIONS
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QBUDI

testing.
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5PQJDBM
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IBT
CFFO

adequately treated.
5.5 Flammable Contents
Topicort
5PQJDBM
4QSBZ
JT
BNNBCMF
LFFQ
BXBZ
GSPN
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PS
BNF

ADVERSE REACTIONS
6.1 Clinical Trials Experience
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8 USE IN SPECIFIC POPULATIONS

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frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
10 OVERDOSAGE
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17 PATIENT COUNSELING INFORMATION
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Table 1. Number (%) of Subjects with Adverse Reactions Occurring in 1%
Topicort Topical Spray,

CJE
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/



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PG
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Application site dryness







Application site irritation







Application site pruritus







black

ES465597_DT0814_TARO2_FP.pgs 07.15.2014 20:41

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CLINICAL DERMATOLOGY

AUGUST 2014 DERMATOLOGYTIMES.COM

21

HERPES LABIALIS:
New delivery system for old drug appears safe, efective from page 18
If it cant prevent the outbreak,
it can shorten the duration of the
outbreak, Dr. Tyring says. There are
longer delays between outbreaks, and
when a person has an outbreak, the
outbreak is less severe. The greatest
benefit, however, was applied during
the prodrome.

In the case of the

topical use of
the medication,
patients need to
constantly reapply
it. With this type of
application, they
simply put it in the
right place and it
stays there.
Stephen Tyring, M.D., Ph.D.
Houston

The phase 3 investigation involving

775 patients with recurrent herpes
labialis revealed that the use of the
drug decreases the risk to experience
a recurrence in nine-month follow-up
by 22.7 percent, and the next recurrence of herpes episode was delayed by
a mean of 105 days in patients whose
herpes lesions recurred. In addition,
there was a statistically significant
difference in the median duration
of herpes episodes, p=0.003, that
favored the novel delivery of acyclovir.
Furthermore, the incidence of blocked
herpes episodes rose by 24.2 percent
with this form of acyclovir.
The tablet uses Lauriad technology
so that a tablet adheres to the gum,
above the incisor tooth on the side

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of the lip that is infected with a cold

sore, providing sustained release local
exposure of acyclovir in oral mucosa,
says Pierre Attali, M.D., M.Sc., chief
operat ing of f icer, St rateg y and
Medical Affairs, BioAlliance Pharma,
Paris, the company that developed
the technology.
The key is milk protein concentrate in the formulation, which facilitates the tablet to adhere to the gum,
Dr. Attali says. This milk protein
concentrate also makes it have a
slower release.
M i l k protei n concent rate is
commonly used as a food additive
and found in many dairy products,
he says.
DELIVERY METHOD

In an oral formulation, acyclovir is

not as bioavailable and even in a
topical formulation applied directly
to the site of the cold sore, according
to Dr. Attali.
The drug is released by the tablet for
12 to 15 hours, which covers the period
where the virus is replicating, Dr.
Attali says. If you look at the concentrations (of the drug) in saliva and
mucosa, they are very high during that
period. The use of this delivery system
means that the lesion can abort. There
are symptoms for one or two days, and
then the lesion disappears.
Indeed, ac yclov i r select ively
inhibits HSV viral DNA replication,
but systemic concentrations are
reduced, delayed, and transient in
the deep layers of mucosa and skin,
thus poorly targeting the mucosal
reservoir of HSV-1.
The amount of milk protein
concentrate in the formulation is
extremely low, so even patients with
lactose intolerance can safely use this
formulation. Younger patients can
take it as well, Dr. Tyring says.
Apart from a significant advantage
in terms of bioavailabilit y, this

formulation requires one application

and eliminates the challenge of
compliance that has existed with the
oral formulation as well as the topical
formulation of acyclovir, he says.

There are longer

delays between
outbreaks, and
when a person has
an outbreak, the
outbreak is less
severe.
Stephen Tyring, M.D., Ph.D.
Houston

There have been obstacles to

overcome to ensure the optimal use
of acyclovir and optimal healing, Dr.
Tyring says. Compliance was always
an issue when it was used five times
a days in the oral form. We began
recommending that patients use it
three times a days and double the
dose. In the case of the topical use
of the medication, patients need to
constantly reapply it. With this type of
application, they simply put it in the
right place and it stays there.
In terms of side effect profile, there
have been some rare instances, less
than 1 percent, of application site
irritation. The incidence of headache
that has been reported with systemic
acyclovir therapy has been 10 percent,
and the incidence is much lower with
this delivery system. DT
Disclosures: Dr. Tyring reports that the clinical studies
were funded by BioAlliance Pharma SA, the developer
of Sitavig. Sitavig is manufactured by Farmea and is
marketed by Innocutis in North America. Dr. Attali is an
employee of BioAlliance Pharma.

ES467457_DT0814_021.pgs 07.21.2014 20:16

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22

CLINICAL

DERMATOLOGY

AUGUST 2014 DERMATOLOGYTIMES.COM

Researchers reconsider
acne development process
Ilya Petrou, M.D. | Senior Staff Correspondent

QUICK READ

Hershey, Pa. There may be

Current advances in the

science of innate immune
defense are helping to further
elucidate the role of P. acnes,
sebocytes and keratinocytes
in the development of acne.

different mechanisms by which

Propionibacterium acnes (P. acnes)
induce acne vulgaris lesions, recent
data indicates. This insight is fueling
a re-evaluation of the development
process of this common dermatologic condition.
The pathogenesis of acne is multifactorial and includes follicular hyperkeratinization, P. acnes proliferation,
sebum production and inflammation.
Although P. acnes was long considered
to further inflame the skin following
the establishment of acne lesions, new
research in this field indicates that
certain strains of the P. acnes bacteria
may have a more direct role in the
genesis of acne lesions.
New insights in the innate immune
responses in acne and about the role of
various cytokines have broadened our
base in the understanding of the pathogenesis of the disease, and may lead
to the development of more effective
and targeted acne treatments in the
future, says Diane M. Thiboutot, M.D.,
professor of dermatology, vice-chair
for research for dermatology, director
of clinical and transitional science
research education, Penn State Hershey
Dermatology, Hershey, Pennsylvania.
ACNE PATHOGENESIS

Previous research on the pathogenesis

of acne found that CD4+ lymphocytes
and interleukin-1 (IL-1) activity were
increased in uninvolved areas of
acne-prone skin prior to the hyperproliferative changes in the follicle,
suggesting that inflammation may
precede hyperkeratinization in microcomedone formation (Jeremy A HT,
Holland DB, Roberts SG, et al. J Invest
Dermatol. 2003;121(1):20-27).
Another previous study looking
at the potential involvement of IL-1
in comedogenesis used human
hair follicles incubated with IL-1
alpha in vitro and found that IL-1
induced hyperkeratinization within

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black

the follicles, very similar to what is

seen in comedone formation (Guy R,
Green MR, Kealey T. J Invest Dermatol.
1996;106(1):176-182).
According to Dr. Thiboutot, more
recent studies performed in the elucidation of the pathogenesis of acne have
further investigated the role of IL-1 in
comedogenesis, with special focus on
the role of inflammasomes.
The inflammasome is a structure
consisting of a series of proteins that
work together within the cytoplasm
and very similar to toll-like receptors,
their task is to recognize foreign
pathogen-derived factors as well as
other molecules that signal cellular
danger, Dr. Thiboutot says.
PRODUCTION OF ACTIVE IL-1 BETA

According to Dr. Thiboutot, the

inflammasome is basically comprised
of a nod-like receptor protein,
caspase-1 and a linker protein.
When the pathogen-derived factor
(or danger signal) interacts with
t he inf lammasome, it activates
caspase-1, which in turn results in
the production of active interleukin-1
beta, a cytokine that is very active in
initiating inflammation.
One recent in vivo study isolated
neutrophils from blood donors and
found that P. acnes was capable of
strongly activating the inflammasome
of human peripheral neutrophils,
resulting in the production of active
interleukin-1 beta (Sahdo B, Srndahl
E, Elgh F, Sderquist B. APMIS.
2012;121(7):652-653).
Another study performed by Qin
and colleagues found that P. acnes can
activate inflammasomes in human
monocytes via the nod-like receptor
protein NLRP3 (Qin M, Pirouz A, Kim

M-H, et al. J Invest Dermatol. 2013

Oct 24), further supporting a role
for the inflammasome activation as
being important in the pathogenesis
of acne lesions. These findings were
soon after corroborated by Kistowska
et al in a parallel study in which
researchers also found that the P.
acnes bacteria can activate inflammasomes via the NLRP3 protein,
leading to the production of active
capsase-1.
The Kistowska group took their
findings a step further and suggested
a mechanism of action, suggested that
P. acnes needed to be phagocytized by
the cells in order to activate the inflammasome. This is process is associated
with the damage to lysosomes and the
generation of reactive oxygen species,
Dr. Thiboutot says.
Looking forward, Dr. Thiboutot says
the next step would be to examine
the mechanisms by which P. acnes
activates the innate immune response
within the unique microenvironments
that arise during acne lesion development and to examine the respective
roles of IL-1 alpha and IL-1 beta in
this process.
These new findings point to one of
the many potential mechanisms by
which P. acnes induces inflammation
in acne, according to Dr. Thiboutot.
They further raise the question,
however, about where in the skin,
how, and at what time in the pathogenesis of acne is P. acnes having its
proinflammatory effect.
We are learning a lot more about
innate immune responses in acne,
about the role of various cytokines,
Dr. Thiboutot says, and one of our
challenges moving forward is to try to
assess the relative importance of the
various cytokines involved in acne,
with the thought towards potential new
treatments that may address those that
seem to be having the largest effect in
inducing inflammation. DT
Disclosures: Dr. Thiboutot reports no relevant
financial interests.

ES470661_DT0814_022.pgs 07.25.2014 00:12

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CLINICAL DERMATOLOGY

AUGUST 2014 DERMATOLOGYTIMES.COM

25

DRUG REACTIONS:

Recognizing symptoms quickly is crucial to managing severe reactions from page 1

Although biopsy and lab tests can
help, he says, The gold standard in
diagnosing drug reactions is rechallenge. But we rarely ever do this, and
clearly not intentionally in severe
reactions.
RARE BUT SEVERE REACTIONS

A mong severe cuta neous d r ug

reactions, he says, toxic epidermal
necrolysis (TEN) manifests as erythroderma and painful desquamation
of the skin. Similar symptoms characterize Stevens-Johnson syndrome, Dr.
Adams says, although it affects 10
percent or less of the body surface
area (BSA), including the epidermis
a nd muc os a . Ste ven s-Joh n son
syndrome (SJS)/TEN overlap impacts
10 to 30 percent BSA, and TEN affects
more than 30 percent BSA, he says.

Any time we use

Tolu balsam to
help tape or sterile
strips adhere, there
is potential for (a)
reaction.
David R. Adams, M.D., Pharm.D.
Hershey, Pennsylvania

Mortality increases with increasing

skin involvement, and with comorbidities such as HIV. TEN probably
has a combination metabolic and
immunologic pathogenesis. The key
here is that if the patients skin hurts,
theres a very short window to make
the diagnosis and begin treatment.
TEN quickly progresses over several
days, and these patients are at high
risk for systemic complications.
Along with discontinuing the
possible associated drugs, he says,
treating TEN requires referring the
patient to a burn unit.
Supportive care by the intensivist
is important; avoid adhesives on the
skin, a common nursing problem,
Dr. Adams says. Ophthalmology
needs to be involved to help manage

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QUICK READ
Handling severe cutaneous
drug reactions requires quickly
recognizing symptoms and,
where applicable, initiating
treatment, an expert says.
ocular manifestations, which can
lead to blindness.
Unfortunately, he adds, the rarity
of TEN makes it difficult to find
strong studies that can help guide
treatment.

every 12 hours for several days, then

transitioning to oral prednisone
tapering over several weeks to
months, depending upon response,
he says.
Nephrogenic systemic fibrosis
(prev iously ca lled nephrogenic
fibrosing dermopathy) a reaction
to gadolinium-enhanced MRI in
patients with advanced kidney disease
presents with very indurated skin
that can make it difficult for patients
to move their fingers or other extrem-

A 75-year-old male patient with

DRESS syndrome associated
with allopurinol. The patient
during hospitalization (left); and
two months after treatment
with systemic corticosteroids
and discontinuation of
allopurinol.
(Photos: David R. Adams, M.D., Pharm.D.)

Depending on where you trained

and your evaluation of current literature, some physicians use corticosteroids; some use IVIG or even
cyclosporine. Some dont use any
medication other than supportive
care. The important point is that after
a couple days, none of these drugs
are likely to have any impact because
skin necrosis has already occurred,
Dr. Adams says.
IDENTIFYING DRESS SYNDROME

Patients experiencing drug reaction

w ith eosinophilia and systemic
symptoms (DRESS syndrome) always
have a fever and some type of rash,
often erythroderma, and varying
degress of organ dysfunction, he says.
Other symptoms can include facial
edema and difficulty swallowing, he
adds. Several dozen agents, including
anticonvulsants, allopurinol and
sulfonamides, have been associated
with DRESS, Dr. Adams says.
Systemic steroids often halt the
process rather quickly, but you must
give enough: methylprednisolone IV
given at least 1 mg/kg body weight

ities, Dr. Adams says. Other signs

include hyperpigmented, hardened
plaques. Although a flurry of cases
occurred when this MRI contrast agent
was first marketed in 1997, he says,
newer radiology screening guidelines
have reduced the use of gadolinium
in the high-risk population with
renal impairment. Because no treatments have been shown to consistently reverse the condition, he says,
prevention is paramount.
Other drug reactions include acute
generalized exanthematous pustulosis (AGEP). In one case, a resident
was called to an ER consult regarding
a patient diagnosed with a potential
groin infection. Closer examination
revealed a symmetrical pattern of
small studded pustules in the groin
area. AGEP also can present as
lakes of pus formed by coalescing
plaques, Dr. Adams says.
These patients also have fever, and
an elevated white blood cell count.
But this can be tricky to diagnose,
because patients do not require prior
exposure to the medication it can
DRUG REACTIONS see page 26

ES474859_DT0814_025.pgs 07.29.2014 23:28

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26

CLINICAL

DERMATOLOGY

AUGUST 2014
2013 DERMATOLOGYTIMES.COM

voice of the dermatologist

Laser technology is so sophisticated now that

if you dont have lasers in your practice youre
not going to be treating a lot of conditions as
effectively.
Bruce Katz, M.D.
See story, page 28

DRUG REACTIONS:

Recognizing symptoms quickly is crucial to managing severe reactions from page 25

be the first time that they receive the
drug, he says. Usually within a day,
they start developing small pustules,
either in the skin folds or on the face,
and then the reaction progresses.
Regarding treatment, he says,
steroids can quell more serious cases.
PALPABLE PURPURA

Regarding palpable purpura, approximately 10 percent of cases occurring

in hospitalized patients are associated
with drugs, Dr. Adams says.
Its probably a type 3 immune
complex reaction. Antibiotics are at
the top of the list of culprit drugs,
he says.
The generalized presentation of
monomorphic symmetrical papules
can signal systemic drug-associated
acne, he says. It is almost always a
reaction to steroids, he adds.
Somewhat simi la rly, he says,
epidermal growth factor receptor
(EGFR) inhibitors can cause a follicular
eruption that shares features of acne
and dermatitis.
You can treat it like acne, but avoid
irritants. Sometimes topical corticosteroids are needed for the dermatitis
component, he says.
SYSTEMIC MEDICATION REACTIONS

Additionally, Dr. Adams says patients

c om mon l y e x per ienc e ad ver s e
reactions to various systemic medications (antihypertensives, hormones,
anticholinergics and others) administered by an applied patch, which
can cause er ythematous patches
within the applied contact surface or

magenta
cyan
yellow
black

may extend beyond the dimensions

of the original patch. If the reaction
occurs beyond the patch border,
some medication patch manufacturers recommend avoiding t he
systemic form of the drug to avoid a
potential severe systemic reaction. All
medication patches approved by the
Food and Drug Administration can
cause such a reaction, he states.

TEN quickly
progresses over
several days, and
these patients
are at high risk
for systemic
complications.
David R. Adams, M.D., Pharm.D.
Hershey, Pennsylvania

Its either allergic or irritant

contact dermatitis. Rarely do these
patients get seriously ill from it, Dr.
Adams says.
In one case that turned out to be
allergic contact dermatitis, he says, a
hospitalized patient had an epidermal
catheter line taped from his back to his
shoulder and the entire length of underlying skin painted with compound
tincture of benzoin to improve tape
adhesion. The patient later developed
an intense pruritic reaction running

the entire length of the catheter. The

adhesive contained Tolu balsam, which
Dr. Adams says is similar to and
can cross-react with balsam of Peru
(Myroxylon pereirae), an allergen often
tested in patch test panels.
Any time we use Tolu balsam to
help tape or sterile strips adhere, there
is potential for this kind of reaction,
he says.
Conversely, acral erythrodysesthesia
is probably related to a drug being
excreted through the sweat glands
and causing a local toxic reaction.
These patients usually complain of
a burning feeling of the hands and/
or feet, Dr. Adams says. After the
medication is discontinued, They
usually heal satisfactorily. It is usually
treated with local cold compresses.
Some reports have suggested topical
or oral vitamin B6, he adds, But Im
not sold on that.
Highly pruritic flat-topped papules
can represent lichen planus (LP)-like
drug reaction, Dr. Adams says. In
several cases, Performing a biopsy
helped us make the diagnosis. The key
is, most often traditional LP affects the
extremities, whereas drug-associated
LP tends to impact the trunk.
What makes this reaction difficult
to diagnose is that it may not happen
for months after the drug exposure,
he adds.
And when you stop the drug, it
may take months to go away, Dr.
Adams says. DT
Disclosures: Dr. Adams reports no relevant financial interests.

ES474860_DT0814_026.pgs 07.29.2014 23:28

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POWERED BY SCIENCE.
PROVEN BY DERMATOLOGISTS.
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AVEENO Skin Relief Moisture Cream

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30

40

50

60

70

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Base: Respondents who purchased (BRAND).
AVEENO n=149; Brand A, n=130; Brand B, n=34

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Moisture Repair Cream when compared to a leading ceramide cream.

(n=35, data on le)

TE

* Signicant improvement (p<0.05) with the AVEENO Skin Relief

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magenta
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yellow
black

ES467167_DT0814_027_FP.pgs 07.18.2014 23:03

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28

COSMETIC DERMATOLOGY

AUGUST 2014 DERMATOLOGYTIMES.COM

FACIAL REJUVENATION
34 Filler
options expand, with new
products aimed at correcting
midface volume loss

TRUE BEAUTY
36 EMPHASIZING
Self-esteem gets a boost after
cosmetic procedures, which
can lead to increased confidence

PART 1

How, why to start a laser practice

Lisette Hilton | Staff Correspondent

QUICK READ

Laser and light device treat-

Before offering laser services at

dermatology practices, clinicians
should do their homework to
ensure theyre spending their
money wisely.

ments are infiltrating cosmetic and

medical dermatology, causing many
in the specialty to consider starting
or grow ing laser practices. W hile
the decision to go into the laser side
of dermatolog y works out well for
many, it can be a costly mistake for
those who dont do their homework,
experts warn.
It was 1990 when
T i n a S . A l s t er,
M.D., started her
laser practice.
Dr. A lster says
she k new of no
ot her laser pract ice in t he world
at t he t i me. She
Dr. Alster
called it the Wash-

Quotable
Te (self-tanner) color
can be lightened by
applying the product to
moist skin or mixing a
small amount of water
with the product ... prior
to application.
Zoe Diana Draelos, M.D.
Durham, N.C.

On how to adjust
self-tanner colors
See story, page 33

magenta
cyan
yellow
black

ington Institute of Dermatologic Laser

Surgery, even though she only had one
laser.
That was a pulsed dye laser that
we used to treat port wine stains and
hypertrophic scars, says Dr. Alster,
who still directs the laser practice in
Washington, D.C.
Since then, Dr. Alsters practice
and laser technology applications in
cosmetic and medical dermatology
have flourished.
Ive pretty much added at least
one laser a year since I opened my
practice, Dr. Alster says.

Bruce Katz, M.D., opened the Juva

Skin and Laser Center in downtown
Manhattan, New York, in 1998. Since
then, the practice has grown to more
than 50 lasers.
Laser technology is so sophisticated now that if you dont have lasers
in your practice youre not going to be
treating a lot of conditions as effectively. We know these devices are very
effective at what they do, Dr. Katz says.
GROWING ONES PRACTICE

Another dermatologist and pioneer

in t he world of lasers: Michael H.
Gold, M.D., medical director of Gold
Sk i n Ca re Center a nd Ten nessee
Clinical Research Center, Nashville,
Tennessee, says the laser practice he
started some 23 years ago features
more than 40 devices today.
LASER PRACTICE see page 42

DTExtra
Val Lambros, M.D., Newport Beach, Calif., said in
his presentation at the annual Vegas Cosmetic
Surgery meeting that although he uses fat in every
facelift he performs and has been using it for
more than 20 years, this natural filler can cause
problems in inexperienced hands. Dr. Lambros
emphasized that fat is unpredictable. A rookie
mistake might be to overgraft fat into the face
to smooth away wrinkles, but if the fat grows
over time, it can make the face unnaturally big,
masking the natural contours. Thus, the wrinkles
may be gone, but patients tend not to be happy
when they no longer look like themselves, he said.
READ MORE: DERMATOLOGYTIMES.COM/FATINJECTION

ES467243_DT0814_028.pgs 07.19.2014 01:49

ADV

Epiduo (adapalene and benzoyl peroxide)

Gel 0.1%/2.5% can help your
patients look forward to clearer skin
Early results and the power to help prevent
breakouts1-4
The ONLY antibiotic-free fixed-dose combination
Efficacy and tolerability proven in patients
9 years of age and older1,5*

TREAT ACNE FROM A DIFFERENT POINT OF VIEW.

PRESCRIBE EPIDUO GEL.

Important Safety Information

Indication: EPIDUO Gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Adverse
Events: In controlled clinical studies, the most commonly reported adverse events (1%) in patients treated with EPIDUO Gel
were dry skin, contact dermatitis, application site burning, application site irritation and skin irritation Warnings/Precautions:
Patients taking EPIDUO Gel should avoid exposure to sunlight and sunlamps and wear sunscreen whensun exposure cannot be
avoided. Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of EPIDUO Gel
and may necessitate discontinuation.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

*A phase 3, randomized, multicenter, double-blind, active- and vehicle-controlled, parallel-group study evaluating the efficacy and safety
of adapalene 0.1%BPO 2.5% fixed-dose combination gel relative to adapalene 0.1% monotherapy, BPO 2.5% monotherapy, and gel
vehicle in a large population for the treatment of acne vulgaris (N=1670).

A multicenter, randomized, vehicle-controlled, double-blind study evaluating the efficacy and safety of adapalene 0.1%BPO 2.5%
fixed-dose combination gel in subjects 9 to 11 years of age with acne vulgaris (N=285).

Please see brief summary of full Prescribing Information on next page.

IMPORTANT INFORMATION ABOUT

EPIDUO GEL

(adapalene and benzoyl peroxide) Gel, 0.1% / 2.5%

BRIEF SUMMARY

WHAT ARE THE MOST COMMON SIDE EFFECTS OF EPIDUO GEL?

This summary contains important information about EPIDUO (EP-E-Do-Oh)

gel. It is not meant to take the place of your doctors instructions. Read this
information carefully before you start using EPIDUO gel. Ask your doctor or
pharmacist if you do not understand any of this information or if you want
to know more about EPIDUO gel. For full Prescribing Information and Patient
Information please see the package insert.
WHAT IS EPIDUO GEL?
EPIDUO gel is a prescription medicine for skin use only (topical) used to treat
acne vulgaris in people 9 years of age or older. Acne vulgaris is a condition
in which the skin has blackheads, whiteheads, and pimples.

The most commonly reported side effects when using EPIDUO gel include
erythema, scaling, dryness, application site irritation, stinging and burning.
Depending upon the severity of these side effects, patients should be instructed
to use a moisturizer, reduce the frequency of the application of EPIDUO gel,
or discontinue use.
Tell your doctor right away if these side effects continue for longer than
4 weeks or get worse, you may have to stop using EPIDUO gel. Tell your doctor
if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of EPIDUO gel. For more
information, ask your doctor or pharmacist.

WHO IS EPIDUO GEL FOR?

EPIDUO gel is for use in people 9 years of age and older. It is not known if
EPIDUO gel is safe and effective for children younger than 9 years old.

You are encouraged to report negative side effects of prescription drugs to

the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also
contact GALDERMA LABORATORIES, L.P. at 1-866-735-4137.

Do not use EPIDUO gel for a condition for which it was not prescribed. Do not
give EPIDUO gel to other people, even if they have the same symptoms you
have. It may harm them.

HOW SHOULD I USE EPIDUO GEL?

Use EPIDUO gel exactly as your doctor tells you to use it. EPIDUO gel is for
skin use only. Do not use EPIDUO gel in or on your mouth, eyes, or vagina.
Apply EPIDUO gel 1 time a day.
Do not use more EPIDUO gel than you need to cover the treatment area.
Using too much EPIDUO gel or using it more than 1 time a day may increase
your chance of skin irritation.

WHAT SHOULD I TELL MY DOCTOR BEFORE USING EPIDUO GEL?

Before you use EPIDUO gel, tell your doctor if you:
have other skin problems, including cuts or sunburn.
have any other medical conditions.
are pregnant or planning to become pregnant. It is not known if EPIDUO gel
can harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if EPIDUO gel
passes into your breast milk and if it can harm your baby. Talk to your
doctor about the best way to feed your baby if you use EPIDUO gel.
Tell your doctor about all of the medicines you take, including prescription
and non-prescription medicines, vitamins, and herbal supplements.
Especially tell your doctor if you use any other medicine for acne. Using
EPIDUO gel with topical medicines that contain sulfur, resorcinol or salicylic
acid may cause skin irritation.
Know the medicines you take. Keep a list of them to show your doctor and
pharmacist when you get a new medicine.
WHAT SHOULD I AVOID WHILE USING EPIDUO GEL?
You should avoid spending time in sunlight or artificial sunlight, such as
tanning beds or sunlamps. EPIDUO gel can make your skin sensitive to sun
and the light from tanning beds and sunlamps. You should wear sunscreen
and wear a hat and clothes that cover the areas treated with EPIDUO gel if
you have to be in the sunlight.
You should avoid weather extremes such as wind and cold as this may
cause irritation to your skin.
You should avoid applying EPIDUO gel to cuts, abrasions and sunburned skin.
You should avoid skin products that may dry or irritate your skin such as
harsh soaps, astringents, cosmetics that have strong skin drying effects
and products containing high levels of alcohol.
You should avoid the use of waxing as a hair removal method on skin
treated with EPIDUO gel.
EPIDUO gel may bleach your clothes or hair. Allow EPIDUO gel to dry
completely before dressing to prevent bleaching of your clothes.

APPLYING EPIDUO GEL:

Wash the area where the gel will be applied with a mild cleanser and
pat dry.
EPIDUO gel comes in a tube and a pump. If you have been prescribed the:
Tube: Squeeze a small amount (about the size of a pea) of EPIDUO gel
onto your fingertips and spread a thin layer over the affected area.
Pump: Depress the pump to dispense a small amount (about the size of
a pea) of EPIDUO gel and spread a thin layer over the affected area.
WHERE SHOULD I GO FOR MORE INFORMATION ABOUT EPIDUO GEL?
Talk to your doctor or pharmacist
Go to www.epiduo.com or call 1-866-735-4137

GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA

Revised: February 2013

References: 1. Gollnick HPM, Draelos Z, Glenn MJ, et al; AdapaleneBPO Study Group. Adapalenebenzoyl peroxide, a unique fixed-dose combination topical gel for the treatment of
acne vulgaris: a transatlantic, randomized, double-blind, controlled study in 1670 patients. Br J Dermatol. 2009;161(5):1180-1189. 2. Czernielewski J, Michel S, Bouclier M, Baker M,
Hensby C. Adapalene biochemistry and the evolution of a new topical retinoid for treatment of acne. J Eur Acad Dermatol Venereol. 2001;15(suppl 3):5-12. 3. Tenaud I, Khammari A,
Drno B. In vitro modulation of TLR-2, CD1d and IL-10 by adapalene on normal human skin and acne inflammatory lesions. Exp Dermatol. 2007;16:500-506. 4. Thiboutot D, Gollnick H,
Bettoli V, et al; Global Alliance to Improve Outcomes in Acne. New insights into the management of acne: an update from the Global Alliance to Improve Outcomes in Acne group. J Am
Acad Dermatol. 2009;60(5)(suppl):S1-S50. 5. Eichenfield LF, Draelos Z, Lucky AW, et al. Preadolescent moderate acne vulgaris: a randomized trial of the efficacy and safety of topical
adapalene-benzoyl peroxides. J Drugs Dermatol. 2013;12(6):611-618.

Galderma and Epiduo are registered trademarks.

2014 Galderma Laboratories, L.P.
Galderma Laboratories, L.P.
14501 N. Freeway
Fort Worth, TX 76177
EPID-114C Printed in USA 01/14

www.epiduo.com/hcp

COSMETIC

AUGUST 2014 DERMATOLOGYTIMES.COM

DERMATOLOGY

33

CAN INFLAMMATION REDUCTION

LEAD TO SLIMMER SKIN?

Zoe Diana Draelos, M.D., is a
Dermatology Times editorial
adviser and consulting professor
of dermatology, Duke University
School of Medicine, Durham, N.C.
Questions may be submitted via
email to zdraelos@
northstate.net

COSMETIC
CONUNDRUMS

Q:
A:

What are slimming

creams?

Patients will bring to me on a

weekly basis tubes of slimming
cream for evaluation. The question
from the concerned consumer is
always the same: Is it wise use of
my money to purchase this product
again and what exactly does a slimming cream do? The honest truth
is that I am not sure what benefit a
slimming cream delivers.
What is slimming? This is truly
a cosmetic concept. Some might
think that slimming implies weight
loss and thinner people are considered slimmer, but nowhere on the
packaging does it discuss body
weight. Others might think that
slimmer indicates a reduction in
body measurement. Again, there is
no mention of inches.
I think slimming means smoother,
softer skin. Most of these products
are based on moisturizers with some
botanical additives. One formulation I examined contained a variety
of botanical anti-inflammatories
including Ginkgo biloba, mallow

magenta
cyan
yellow
black

extract (Malva sylvestris), and hares

ear (Bupleurum falcatum).
Perhaps a reduction in inflammation can lead to slimmer skin.
The trick is to create a cream for a
consumer perceived need that does
not have a medical definition. This
then means that the product is a
cosmetic and can deliver whatever
the consumer wants the product to
deliver. Ambiguity is good from a
regulatory standpoint.

The pH level of
the skin and the
formulation can
also change the
color of the DHAinduced skin stain.

Q:
A:

How can the color of selftanning creams be adjusted?

I recommend self-tanning
creams for my patients who want
some color, but they tell me the end
result is too dark or too orange.
Self-tanning creams are being
recommended by dermatologists
more frequently as patients are told
to use them to achieve browner
skin without sun exposure. All selftanning creams contain a threecarbon sugar that appears as a white,
crystalline hygroscopic powder
known as dihydroxyacetone (DHA).
DHA is formed when glycerol
is fermented by Gluconobacter
oxydans. It interacts with amino
acids, peptides and proteins to form
chromophobes known as melanoi-

dins. Melanoidins structurally have

some similarities to skin melanin,
but are not photoprotective.
The depth of color is created by
the amount of DHA applied and the
amount of protein present in the
skin. In areas where the stratum
corneum is thicker, such as the
palms, soles, elbows, and knees,
the brown color appears darker. In
areas where the stratum corneum
is thinner, such as the face, the
resultant brown color is lighter.
This is why skin exfoliation prior to
applying the self tanner can cause a
lighter brown stain.
The pH level of the skin and the
formulation can also change the
color of the DHA-induced skin
stain. If the skin or the formulation is alkaline, the DHA color
will be more orange. Conversely,
if the skin or the formulation is
acidic, the DHA color will be more
natural in appearance. The optimal
pH for the best color development is 5-6. For this reason, the
self-tanner should be applied
to freshly washed skin to avoid
uncontrollable color development.
The amount of water in the
formulation can also affect the
DHA color. If too much water is
present, the DHA color will be
lighter. This may be desirable for
those who think the color is too
dark. The color of the self-tanner
can be lightened by applying the
product to moist skin or mixing
a small amount of water with the
product in the palm of the hand
prior to application.
Conversely, there are those who
want a darker self-tanning color.
It has been noted that propylene
glycol and sorbitol increase the
tanning intensity. These are some
easy-to-relate suggestions that can
be shared with patients. DT

ES467458_DT0814_033.pgs 07.21.2014 20:16

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34

COSMETIC

DERMATOLOGY

AUGUST 2014 DERMATOLOGYTIMES.COM

Growing array of fllers expands

options for facial rejuvenation
Cheryl Guttman Krader | Staff Correspondent

QUICK READ

Wailea, Hawaii Injectable

The latest addition to the

armamentarium of injectable
fllers is Juvderm Voluma, the
frst product with an indication for
correcting age-related midface
volume loss. Several other new
products are under investigation.

fillers are used in a variety of ways to

improve the appearance of the aging
face. However, because not all fillers are
alike, it is important for dermatologic
surgeons to understand the features
and benefits of each product in order to
optimize its clinical use, says W. Philip
Werschler, M.D.
R e c e n t l y, t h e
a r ma menta r ium
of injectable fillers
was expanded by
the Food and Drug
Administrations
approval of a novel
hy a lu r on ic ac id
(H A) gel product
W. Philip Werschler, M.D.
t hat holds t he
distinction of being the first filler indicated for correcting age-related midface
volume loss (Juvderm Voluma XC
20 mg/mL, Allergan). Dr. Werschler
discussed this new filler option and
other developments at the MauiDerm
2014 meeting.
Manufactured w ith proprietar y
crosslinking technology (Vycross), the
new HA filler gel from Allergan flows
easily and yet has increased stiffness,
firmness and durability compared with
other products in the HA category.
Vycross tech nolog y produces
a hig h ly crosslin ked gel t hat has
enhanced longevity and lifting capacity,
which opens up new opportunities
for midface volumization, says Dr.
Werschler, who practices in Spokane,
Washington, and is associate clinical
professor of medicine/dermatology,
University of Washington, Seattle.
TRIAL RESULTS

The pivotal clinical trial leading to

approval of the new filler was conducted
at 15 sites in North America. It included
235 patients who were treated to correct
midface volume deficit and 47 untreated
controls. Eligible patients had moderate,
significant or severe midface volume
deficit as assessed using a six-point validated rating scale.
Patients in the treatment group
received injections into one, two or
three subregion treatment areas (zygo-

magenta
cyan
yellow
black

maticomolar, anteromedial cheek and

submalar) and could receive a touch-up
one month later to optimize the results.
Median injection volume was 6.6 mL
(range 1.1 mL to 13.9 mL). Follow-up
visits were scheduled quarterly through
24 months.
Effectiveness was evaluated by
two blinded investigators, and the
primary endpoint was assessed at 6
months. According to the protocol,
the product was considered clinically effective if at least 70 percent
of pat ients were responders (i.e.,
achieved a 1-point improvement
from baseline in the midface volume
deficit scale); the primary endpoint
was met as the responder rate at six
months was 85.6 percent.

The new HA filler

gel from Allergan
flows easily and
yet has increased
stiffness, firmness
and durability.
D u rat ion of ef fec t iveness w a s
analyzed using Kaplan-Meier statistics, and the data on maintenance of
correction showed patients rated their
outcomes better than the investigators at all follow-up time points. Based
on the patient ratings, the estimated
probability of maintaining correction was 95 percent at six months, 80
percent at 12 months, and 54 percent
at 24 months. According to the investigators ratings, the estimated probability of maintaining correction at
six, 12 and 24 months was 77, 64 and
46 percent, respectively.

These data indicate that improvement

may persist for up to two years in about
half of patients, Dr. Werschler says.
However, keep in mind that filler
duration claims are a slippery slope,
and I would encourage you never to
give patients estimates using absolute
numbers. Rather, suggest a range of
time that leans toward the conservative side, he says.
MORE HA PRODUCTS

Belotero Balance Dermal Filler (Merz

Aesthetics), the HA filler using a proprietary cohesive polydensified matrix
(CPM) technology, was also reintroduced recently. A main feature of this
product is that it has less homogenous
bulk. Therefore, it causes less monochromatic refraction of ambient light.
Based on this property, we can
Belotero Balance superficially in patients
with Fitzpatrick skin types 1 and 2,
and be relatively assured that these
fair-skinned individuals will not have a
bluish discoloration (Rayleigh effect),
Dr. Werschler says.
He also called dermatologists attention to another recently approved HA
filler that is indicated for use as an
intranasal splint (Expression, Enhancement Medical), but is being heavily
marketed in the aesthetics community.
It is produced using a nonpathogenic
bacteria, Bacillus subtilis, in a waterbased process that is touted for eliminating the risk of residual toxins and the
need for organic solvents.
Looking ahead, Dr. Werschler notes
that Allergan is conducting clinical trials
with two other new HA formulations
made with Vycross technology (Volbella
and Volift). In addition, the recent acquisition of Anteis by Merz may result in
more products in the Belotero family
becoming available in the United States.
New products may also be forthcoming
from Alphaeon, which has become a
new player in the filler market. Alphaeon
acquired the U.S. licensing rights for the
HA filler and skincare line of Teoxane
Laboratories, and it has several fillers and
a neurotoxin in development, as well. DT
Disclosures: Dr. Werschler is a consultant, advisory
board member, investigator, and or/speaker for multiple
companies marketing filler products.

ES467238_DT0814_034.pgs 07.19.2014 01:48

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ES467201_DT0814_035_FP.pgs 07.18.2014 23:06

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36

COSMETIC

DERMATOLOGY

AUGUST 2014 DERMATOLOGYTIMES.COM

True beauty lies in intangibles

John Jesitus | Senior Staff Correspondent

L as Vegas For a l l ou r societys emphasis on physical beauty,

nothing is sexier than self-esteem.
This was the theme of Subliminally
Exposed, a performance given by
Steven Daya n, M.D., a nd Va ler ie
Monroe, beauty director of O, The
O p r a h M a g a z i n e , a t C o s m e t i c
Surgery Forum, held here.
T h e p e r f o r ma nce i nter m i ngled scient if ic
data w it h Dr.
Dayans observat ion s r e g a r d i n g
t h e i m p or t a nc e
of physical
attractiveness in
Dr. Dayan
contemporar y
societ y a nd Ms. Monroes ref lections on how such inf luences have
impacted her life.
Much resea rch suppor t s t he
obser vat ion t hat physica l at t ractiveness confers advantages, from
the bedroom and boardroom to the
ability to get out of parking tickets,
Dr. Dayan says. While men compete
based on resources and status, he
add s, women of ten e x pre s s t h i s
dynamic by competing via physical
beauty. For example, Who Wore It
Best sections a common theme in
fashion magazines targeting women
ask readers to judge which celebrity looks better in a certain outfit.
However, he says, such sections never
appear in mens magazines.
MAKING COMPARISONS

Ms. Monroe says she began comparing

her appearance to that of other women
early in life. Her mother was a living
Barbie doll, she explained, a ravenhaired, statuesque model with unrealistic proportions.
Li ke t he dol l, she adds, Ms.
Monroes mother had an extensive

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QUICK READ
Self-esteem gets a boost after
cosmetic procedures, which
may also lead to an increase in
confdence.
wa rd robe i nclud i ng match i ng
mother-daughter outfits.
I remember thinking about the
t wo of us d ressed a l i ke one, a
full-blown goddess, larger-than-life,
the other, a sk inny, freck le-based
tadpole, an anonymous, unfinished
pencil sketch. As far as my appearance was concerned, I was undefined, except in relation to another
woman, Ms. Monroe says.
It s e a s y t o f a l l s hor t i n s uc h
c ompa r i s on s, s ay s D r. Day a n, a
plast ic su rgeon who pract ices i n
Chicago. A neuropsychiatr y study
re ve a le d t h at s ubt le a nd ba rel y
perceptible alterations in a face can
completely alter another persons
perception of that face (Walker M,
Vetter T. J Vis. 2009;9(11):12).

We can make the

perfect face. But
many other things
go into it most
importantly, nothing
is more attractive
than self-esteem.
Steven Dayan, M.D.
Chicago

Additionally, he says, attempting

to guess the age of attractive people
based on facial photos causes the
brains pleasure centers to spike.
But i f I a s k you to judge how
beautiful a person is, your pleasure

centers are no longer rewarded at that

same level, Dr. Dayan says. Only
when it happens subconsciously do
you experience the full pleasure of
something beautiful. This was the
aha moment for me: I realized that
if you have to think about beaut y,
youre no longer rewarded by it.
SUBTLE CHANGES

This truism largely explains the value

of subtlety in cosmetic surgery, Dr.
Dayan says. In short, results arent
perceived as beautiful if people can
tell a patient has had work done.
To see if treatment of the forehead
with abobotulinumtoxinA allowed
patients to make a better first impress ion , D r. Da y a n a nd c ol le a g ue s
c onduc t e d a s t ud y i nv ol v i ng 4 0
p a t i e n t s w h o s e p o s t-t r e a t m e n t
photos were evaluated by unknowing
observers (Dayan SH, Lieberman ED,
Thakkar NN, et al. Dermatol Surg.
2008;34(Suppl 1):S40-S47).
U lt i mately, he
says, I cou ld nt
see a dif ference.
And I have a
trained eye.
Dr. Dayan
s a y s , ho w e v e r,
his young daughters immediately
Ms. Monroe
cou ld tel l wh ich
of two patient photos looked more
attractive.
Then when I put the photos in
contrast, I could see that the difference wasnt about wrinkles. Its not
that were removing wrinkles we
are widening the eyes, making them
look further apart and more infantile.
We are all attracted to wide, infantile
eyes because they appear safe and
nonthreatening, he says. So if we
can take someone who has narrow
eyes, whose appearance scares us,
and widen their eyes using neuroTRUE BEAUTY see page 39

ES467456_DT0814_036.pgs 07.21.2014 20:16

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Except as otherwise indicated, all product names, slogans, and other marks are trademarks of the Valeant family of companies.
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NEW
STRENGTH!

Introducing
RETIN-A MICRO

(tretinoin) Gel microsphere,

Exclusively available in a 50g pump

Except as otherwise indicated, all product names, slogans, and other marks are trademarks of the Valeant family of companies.
2014 Valeant Pharmaceuticals North America LLC. DM/RAM/14/0003 06/14 Printed in USA.

AUGUST 2014 DERMATOLOGYTIMES.COM

COSMETIC DERMATOLOGY

39

TRUE BEAUTY:
Boost of self-esteem after cosmetic procedures can lead to increased confdence from page 36
modulators, fillers or whatever measures we have, we instantly make them
appear more friendly and attractive.
Conversely, aging extracts a toll. In
this regard, Ms. Monroe recounts her
experience greeting patrons at the
door of a friends art exhibit.

If you have
benefited from the
currency of your
looks, when that
currency loses its
value, you can feel
pretty bankrupt.
Valerie Monroe
Beauty director, O, The Oprah Magazine

Hi there, I would say with warmth

and what I thought was a touch of
modest charm. Time and again, from
the men, I got a limp, dismissive, Hi
in response. It wasnt the Whistlers or
the Chagalls that were diverting the art
lovers attention it was my friends
lovely assistant, Ms. Monroe says.
The assistant wasnt flashy or glamorous, Ms. Monroe says. But she had
t he smoot h, milk y, 20-somet hing
complexion, and the sweet, expectant,
wide-eyed look of youth. Thirty years
ago, I might have been her.
But now, Ms. Monroe says, Im 63,
and I look it. Almost every morning, I
discover another small reminder that
Im growing older an age spot, a
new wrinkle. And I discovered at that
art fair that if you have benefited from
the currency of your looks, when that
currency loses its value, you can feel
pretty bankrupt.
T he lack of apprec iat ive ma le
glances reminded her, somewhat
rudely, that shes no longer fertile, Ms.
Monroe says.
That means, in a Darwinian sense at
least, that Im over. The thing is, though

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my production line has shut down, the

factory is still very much open. And I
believe theres more work to be done
before it closes for good, she says.
FINDING SATISFACTION

The late psychologist Erik Erikson

suggested t hat t here a re ma ny
ways to express a concept he called
generativity the need to produce
something that contributes to the
betterment of society, which not only
helps others, but also makes us feel
more content as we get older, Ms.
Monroe says.
That will be my focus, as I march,
largely invisible, into my future. But
I can tell you this: Even if you dont
see me, you will know that I am here,
she says.
Dr. Dayan adds, As we mature,
we grow more satisfied with who we
are. However, we still care about our
appearance whether its makeup,
or brushing your hair or putting on
nail polish or a new outfit, wanting
to feel beautiful is natural at all ages.
After cosmetic treatments, he says,
Our self-esteem rises, regardless of
the treatment. And theres evidence
t hat cosmet ic t reat ment f rom
makeup to hair care to clothing to
aest het ic t reat ments (Daya n SH,
Arkins JP, Patel AB, Gal TJ. Dermatol
Surg. 2010;36(Suppl 4):2088-2097)
improves our mood.
Therefore, Dr. Dayan says, The
goa l of aest het ic med icine is not
necessarily to be beautiful, but to feel
beautiful. People who feel beautiful
have better posture they stand
taller. They are more extroverted and
likable. People who feel beautiful
look beautiful. They smile more,
which elevates their mood through
biofeedback.
With current aesthetic technology
and a mathematical understanding
of the ideal intercanthal distance, Dr.
Dayan says, We can make the perfect
face. But many other things go into it
most importantly, nothing is more
attractive than self-esteem.
A n a necdote f rom Ms. Mon roe
illustrates this point.

As Im walking down a crowded

city street, a gorgeous young creature
sleek and glossy as a black cat
crosses my path. Youll never look
like that again, says my comparing
mind. The woman and I stop at a
curb. Her beauty imbues her with a
mild haughtiness. In her regal way,
she turns her head in my direction,
and I catch her eye. You, I say, are
simply magnificent. The haughtiness va n ishes i nsta nt ly. Sl ig ht ly
taken aback, the woman smiles and
says Thank you.
M s . Mon ro e repl ie d, It s my
pleasure to tell you. Because I not
only remember how happy I have
felt as the recipient of an authentic
complement, but now I c a n a lso
enjoy the additional gratification in
being able to give one. After years of
passively accepting a definition of
beauty other than my own, of striving
to be a noticeable object, Ive now
taken on an active role, too: appreciator of all things beautiful.

Only when
it happens
subconsciously
do you experience
the full pleasure
of something
beautiful.
Steven Dayan, M.D.
Chicago

As an appreciator, Ms. Monroe

says, Im setting my own standards.
Shall I compare thee to a summers
day? No. I wont compa re you or
myself to anything. Because a thing
of beaut y needs no comparison
only an eye to behold it. DT
Disclosures: Ms. Monroes comments originated
as articles in O, The Oprah Magazine. Dr. Dayan
reports no relevant financial interests.

ES467453_DT0814_039.pgs 07.21.2014 20:16

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40

COSMETIC

DERMATOLOGY

AUGUST 2014 DERMATOLOGYTIMES.COM

Subcutaneous bumps a bacterial

consequence of fllers
Lisette Hilton | Staff Correspondent

QUICK READ

Copenhagen, Denmark Fillers

Clinicians can minimize adverse

events from fller injections
by heeding high standards of
hygiene and in some cases
prophylactic antibiotics,
researchers explain.

injected to enhance beauty have an ugly

side effect, which is tricky at best to
prevent and treat, according to a study
published recently.
I n t h e s t u d y,
published online
Feb. 18 in Pathogens and Disease,
researchers at
the Universit y of
Copenhagen used
a mouse model to
learn more about
Dr. Bjarnsholt
how and why subcutaneous lumps sometimes form at the
injection site, immediately or even years
after injections with popular filler products. These bumps can be hard to treat
and many physicians treat them incorrectly, leading to lesions that do not heal,
says senior author Thomas Bjarnsholt,
D.Med.Sc., Ph.D., professor, department
of international health, immunology and
microbiology at the university.

by Mor ten A l hede, Ph.D., for t he

study. Fortunately, many of the filler
producers have now become aware of
the risk of bacteria and recognize that
the gel can act as a bacterial incubator.

Infected tissue filler seven days after injection

in mice. The filler was contaminated with only
10 bacteria resulting in more than 10 million
bacteria after seven days.
EXAMINING ADVERSE EVENTS

Adverse reactions to tissue fillers can be seen

as swellings or nodules. The patient seen here
is shown after four days of steroid treatment
(Photos: Thomas Bjarnsholt, D.Med.Sc., Ph.D.)

The study confirms what previous

resea rchers have fou nd, t hat t he
u n s i g ht l y bu mp s a r e c au s e d b y
bacteria injected in connection with
the cosmetic procedure.
Because a lot of cosmetic practitioners refuse to accept that side effects
from filler procedures are caused by
bacteria, claiming that such problems
are caused by allergic reactions, the
usual procedure has been to treat with
steroids. Steroids interfere (with) and
inhibit the immune response, enabling
the bacteria to multiply even further,
says Dr. Bjarnsholt, who was assisted

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T he resea rchers st ud ied t h ree

d i f ferent gels: a polyac r yla m ide
hydrogel permanent filler (Aquamid,
Cont u r a I nter nat iona l); a sem ipermanent calcium hydroxylapatite
filler (Radiesse, Merz Aesthetics); and
a temporar y hyaluronic acid filler
(Restylane, Medicis). They cultured
Pseudomonas aeruginosa, Staphylococcus epidermidis and Propionibacterium acnes in all three gels.
I n gene r a l , t he f r e quenc y of
adverse events is highest with the
permanent fillers and less with the
temporary ones, Dr. Bjarnsholt says.
That fits with our data showing that
the temporary fillers had the least
sustainment of bacteria. However,
one should note that the temporary
fillers need to be injected very often
and, therefore, the risk of adverse
events increases.
They mimicked the injection of
tissue fillers in mice by injecting the
fillers under the skin, at the neck.

We injected both contaminated

f i l lers a nd clea n f i l lers, but w it h
contaminated needles. As few as 10
bacteria were enough to give the same
adverse events as observed in humans.
We could not detect any adverse events
without bacteria, he says.
GOOD NEWS, BAD NEWS

When they looked at how best to treat

the infection, researchers found good
and bad news. The bad news: Once the
bacteria had settled into biofilms within
the gels, even successive treatments
with high concentrations of antibiotics
didnt help. They were able, however, to
prevent bacteria from forming on the
biofilms with prophylactic antibiotics.
They injected antibiotics with the fillers
during the cosmetic treatments.
Dermatologists can apply the
knowledge to practice with vigilance,
Dr. Bjarnsholt says.
The data suggest
that bacteria comes
from the skin and
that these bacteria
Dr. Alhede
are impossible to
avoid completely even with good
hygiene. A very high standard of hygiene
is of utmost importance, though, to
minimize such adverse events. Use of
makeup prior to injections is very risky
in terms of infections since bacteria have
a nice habitat in makeup, according to
the author.
To prevent such infections, t he
authors recommend a strict aseptic
injection technique, thorough skin
decontamination and proper antibiotic prophylaxis.
That care has to be taken no matter
what you inject, Dr. Bjarnsholt says.
There is a risk every time you inject (a)
foreign material.
Researchers estimate bacterial infections occur every one in 100 to one in
1,000 treatments, depending on the type
of filler, according to a news release on
the study. DT
Disclosures: Dr. Bjarnsholt reports no relevant
financial interests.

ES468014_DT0814_040.pgs 07.22.2014 03:28

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ES467183_DT0814_041_FP.pgs 07.18.2014 23:04

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42

COSMETIC

DERMATOLOGY
DERMATOLOGY

AUGUST 2014
2013 DERMATOLOGYTIMES.COM

voice of the dermatologist

Community outreach efforts ... often lead

to intangible, long-lasting and positive
effects for your practice perception.
Melanie Palm, M.D.
See story, page 69

LASER PRACTICE:
Ensure your practice spends its money wisely before jumping into laser services from page 28
I star ted in t he laser business
through a chance meeting with the
head of the then ESC Medical who
asked me if I would be interested in
tr ying to remove hair with pulsed
light. That was a novel concept many
yea rs ago. From t here I bega n
work i ng w it h m a ny of t he te c hnologies that we have on the market
today, Dr. Gold says. Lasers and
light sources were a way to introduce my sk ills and my practice to
the people in middle Tennessee, and
this was very helpful in growing my
clinical practice.
But t h i ngs have got ten more
c ompl ic at e d s i nc e t he pione er s
in dermatolog y started their laser
practices.
Finding the financial wherewithal
to start a laser practice with one laser
in 1990 was hard enough, says Dr.
Alster, clinical professor of dermatolog y at Georgetow n Un iversit y
Hospital, Washington, D.C. Today,
laser and other device options are
vast and the costs associated with
ow ning or leasing the technolog y
can financially strain dermatology
practices.
Sta r t i ng a laser prac t ice ta kes
pla n n i ng a nd requ i res der matologists dont try to cut the wrong
corners, Dr. Katz says.
There are specific technologies
for specific conditions. The problem
people get into is they buy one or two
devices and try to use those for things
they really arent indicated for. That

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ends up backfiring on them because

theyre using the laser inappropriately, Dr. Katz says.

Laser technology
is so sophisticated
now that if you
dont have lasers
in your practice
youre not going to
be treating a lot
of conditions as
effectively.
Bruce Katz, M.D.
New York

TEST THE WATERS

look at the need in their communities, ask ing whether theres room
for a laser practice, says Elizabeth
L. Tanzi, M.D., clinical professor of
dermatology at George Washington
Un i v e r s i t y Me d ic a l C e n t e r a n d
co-director of the Washington Institute of Dermatologic Laser Surgery.
(Having a) really good, solid business plan before engaging in any sort
of investment is a wise thing to do,
Dr. Tanzi says.
Dermatologists should look at the
communities in which t hey practice or plan to practice to see what
technologies are already available,
according to Dr. Gold. Depending on
the supply and demand, a dermatologist might want to open laser practices similar to those in the communit y, but often, the goal is more to
differentiate themselves from whats
already available at other dermatologists offices, he says.
TAP EXISTING PATIENTS

W het her a der matolog ist shou ld

open a laser pract ice is based on
sound business principles. Is there
a need? A nd ca n
a der m at olo g i s t
accommodate the
need for less than
what it costs to
start and run the
laser business?
Dermatologists
just get t i ng i nto
Dr. Tanzi
pr ac t ic e s hou ld

Existing dermatology patients are a

built-in supply chain for laser practices. Determining that need should
be a first-line approach for experienced dermatologists who want to get
into the laser business, says Dr. Katz,
who directs the cosmetic surgery and
laser clinic at Mount Sinai Medical
Center, New York. This exercise also
helps der matolog ist s deter m i ne
which lasers they should get to meet
the needs of their patients.
LASER PRACTICE see page 49

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AUGUST 2014 DERMATOLOGYTIMES.COM

COSMETIC DERMATOLOGY

49

voice from the industry

A fun way to increase engagement with

Facebook fans is by bringing live video
events to your page.
Patricia Redsicker
See story, page 71

LASER PRACTICE:
Ensure your practice spends its money wisely before jumping into laser services from page 42
First, define the practice, Dr. Katz
says. Does the dermatologist have
a practice full of older, fair-skinned
patients, with a lot of sun damage
in Florida, for example? Or is it an
urban practice catering to younger
people of all ethnicities, who might
be more interested in having toned,
fit looking bodies than in facial rejuvenation? Still other dermatologists
might focus on patients in the inner
city, who want their tattoos removed.

Starting a laser
practice takes
planning
and requires
dermatologists
dont try to cut the
wrong corners.
You h a v e t o t h i n k a b ou t t he
demographics of your patient base to
determine what kind of laser is going
to be used most frequently, he says.
Medical dermatologists might ask
themselves a different set of questions, according to Dr. Tanzi.
D o y ou f r e q ue nt l y r e f e r t o a
surgeon? Do you see a lot of scars in
your office from skin cancer surgery?
Do you want to be able to treat those
patients? Are you seeing children?
Dr. Tanzi says.

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Terrence Keaney, M.D., assistant

clinical professor in dermatology and
urology at George
Washington
Universit y and a
dermatologist who
practices with Dr.
Alster, says lasers
were a must-have
when he sta r ted
a mens cosmetic
Dr. Keaney
center within the
Washington Institute of Dermatologic
Laser Surgery. Men are more accepting
of lasers than they are of other cosmetic
procedures, he says.
What Im finding with male patients
is injectables still have a little of that
taboo. Men are more comfortable
with the treatment of rosacea, or the
treatment of a pre-existing scar or a
birthmark, and that often leads into
other procedures, like injectables, Dr.
Keaney says.
LASERS NOT FOR EVERYONE

While lasers are popular and might

be a smart business move for many
de r m at olo g i s t s , l a s e r pr ac t ic e s
arent for everyone, experts say. The
equipment can put a damper on your
bottom line if it isnt used. And some
dermatologists simply dont have the
patient base to justify a laser practice.
I dont t hink its necessar y for
someone w ho is doi ng ped iat r ic
dermatology. They might need a laser
for port wine stains but dont need it
for anything else, Dr. Katz says. Or
someone who is just doing clinical
dermatology might not need a laser

at all. It depends on your practice and

patient population.
Money is big issue for many dermatologists who might otherwise start
or expand their laser practices.

Maintenance
costs of lasers can
be upwards of
$8,000 to $10,000
a year per laser.
Elizabeth Tanzi, M.D.
Washington, D.C.

Not only are (lasers) expensive to

purchase, but theyre also expensive
to maintain, Dr. Tanzi says. Maintenance costs of lasers can be upwards
of $8,000 to $10,000 a year per laser.
So, these are all things to consider
before investing in lasers.
Jessic a J. K ra nt, M.D., M.P.H.,
who practices on 5th Avenue in New
York City and is an assistant clinical
professor of dermatolog y at SUNY
Downstate Medical Center, says she has
lasers at her solo practice and would like
to have more.
But I simply cannot afford them,
she says. DT
Disclosures: Dr. Alster reports financial interests
in Cynosure, Home Skinovations, Palomar and
Syneron. Dr. Tanzi is on the medical advisory
board for Zeltiq, Miramar and Clarisonic. Dr.
Keaney reports no relevant financial interests.

ES467244_DT0814_049.pgs 07.19.2014 01:49

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50

CUTANEOUS ONCOLOGY

AUGUST 2014 DERMATOLOGYTIMES.COM

DERMATOPATHOLOGY REPORTS
64 Margin
comments in nevi
histology reports impact
re-excision rates

Te role of the dermatologist

in diagnosing, managing
advanced basal cell carcinoma
Snehal P. Amin, M.D., F.A.C.M.S. | Contributing Author
Lavanya Krishnan, M.D., M.S. | Contributing Author

Advanced basal cell carcinoma

is a term whose frequency of usage has
increased recently, in part, due to the
introduction of the Hedgehog pathway
inhibitor, vismodegib. Advanced basal
cell carcinoma (aBCC) is comprised of
two subtypes of BCC associated with
significant morbidity and mortality,
locally advanced BCC (laBCC) and
metastatic BCC (metBCC).
A lt hough basa l cell carcinoma
(BCC) is the most common malignancy in the world, the incidence
rate of metBCC is exceedingly low,
between 0.0029-0.55 percent.1 On the
other hand, locally advanced basal cell
carcinoma is more common (about 1
percent) and may result in destruction

Quotable
It looks like most
practicing dermatologists
have come to some good
conclusions regarding
when to re-excise the
lesion, and which types
of lesions (in terms of
their atypia) to re-excise.
Richard L. Spielvogel, M.D.
Newtown Square, Pa.

On re-excision rates
See story, page 64

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of underlying appendages, nerves,

muscle, bone and cartilage. Given the
high incidence of BCC in general, even
a low recurrence rate of 1 to 3 percent
following surgery could lead to significant numbers of complicated and
recurrent BCCs, some of which may
eventually become advanced BCC.
Some estimates suggest that more
than 3,000 deaths may be associated
with advanced BCC each year in the
United States. 2 Given that most of the
advanced BCC that the practicing
dermatologist will encounter are not
metastatic BCC, this article will focus
on the diagnosis and management of
laBCC by dermatologists.
DIAGNOSIS OF LABCC

There are no def init ive select ion

criteria for what type of BCC should

be designated as locally advanced;

that determination is generally made
by the treating physician. Some of the
clinical criteria for laBCC are listed in
Figure 1 (see page 62). These clinical
criteria include extensive or invasive
tumors, multiple recurrences, highrisk locations, and involvement of
vital structures. High tumor burden
may also be considered a criterion for
laBCC even though individual lesions
may not be severe.
It is important to note that not all
laBCC cases should be treated with
oral Hedgehog pathway inhibitors;
these systemic drugs are appropriate
only for laBCC cases t hat are not
candidates for surgery or radiation.
For example, multiple recurrences
a lone may ju st i f y a d iag nosis of
BCC see page 53

DTExtra
Hawaii Gov. Neil Abercrombie signed a bill that
prohibits minors under the age of 18 from indoor
tanning, according to a news release. The bill is
effective immediately. The risk for developing
melanoma increases by 59 percent in individuals
who have been exposed to UV radiation from
indoor tanning devices. ... Since 2.3 million
teens tan indoors in the United States annually,
restricting teens access to indoor tanning is
critical to preventing skin cancer, said Brett
M. Coldiron, M.D., F.A.A.D., American Academy
of Dermatology president, in a news release.
SOURCE: DERMATOLOGYTIMES.COM/HAWAIIBAN

ES468360_DT0814_050.pgs 07.22.2014 23:47

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Finacea (azelaic acid) Gel, 15% is indicated for topical treatment of

inammatory papules and pustules of mild to moderate rosacea.
Although some reduction of erythema which was present in patients
with papules and pustules of rosacea occurred in clinical studies,
efcacy for treatment of erythema in rosacea in the absence of
papules and pustules has not been evaluated.

Rosacea is with her

wherever she goes .
So is Finacea .

Its true. Rosacea is complex and its with her for life. Pivotal
clinical studies showed reduction of inammatory papules and
pustules of mild to moderate rosacea and some reduction of
associated erythema. Efcacy for treatment of erythema in rosacea
in the absence of papules and pustules has not been evaluated.
You have made Finacea the #1 Dermatologist-prescribed
topical rosacea brand.1

INDICATION & USAGE

Finacea (azelaic acid) Gel, 15% is indicated for topical treatment of inammatory papules and pustules of mild to moderate rosacea.
Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies,
efcacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.
IMPORTANT SAFETY INFORMATION
Skin irritation (e.g. pruritus, burning or stinging) may occur during use with Finacea, usually during the rst few weeks of treatment. If
sensitivity or severe irritation develops and persists during use with Finacea, discontinue use and institute appropriate therapy. There
have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with
dark complexion, monitor these patients for early signs of hypopigmentation.
Avoid contact with the eyes, mouth, and other mucous membranes. In case of eye exposure, wash eyes with large amounts of water.
Wash hands immediately following application of Finacea.
Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents. Avoid the use of occlusive dressings or wrappings.
In clinical trials with Finacea, the most common treatment-related adverse events (AEs) were: burning/stinging/tingling (29%),
pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). Contact dermatitis, edema and acne were observed at
frequencies of 1% or less.
Finacea is for topical use only. It is not for ophthalmic, oral or intravaginal use. Patients should be reassessed if no improvement is observed
upon completing 12 weeks of therapy.
Please see Brief Summary of full Prescribing Information on adjacent page.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
1. According to IMS NPATM (National Prescription Audit) July 2010-June 2014
2014 Bayer HealthCare Pharmaceuticals Inc. Bayer, the Bayer Cross, Finacea and the Finacea logo are registered trademarks of Bayer. All rights reserved. FIN-10-0001-14f | July 2014

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FINACEA
(azelaic acid) Gel, 15%

For Dermatologic Use OnlyNot for Ophthalmic, Oral, or Intravaginal Use

Rx only
BRIEF SUMMARY
CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
FINACEA Gel is indicated for topical treatment of the inflammatory papules and
pustules of mild to moderate rosacea. Although some reduction of erythema which
was present in patients with papules and pustules of rosacea occurred in clinical studies,
efficacy for treatment of erythema in rosacea in the absence of papules and pustules
has not been evaluated.
5 WARNINGS AND PRECAUTIONS
5.1 Skin Reactions
Skin irritation (i.e. pruritus, burning or stinging) may occur during use of FINACEA Gel,
usually during the first few weeks of treatment. If sensitivity or severe irritation develops
and persists, discontinue treatment and institute appropriate therapy.
There have been isolated reports of hypopigmentation after use of azelaic acid. Since
azelaic acid has not been well studied in patients with dark complexion, monitor these
patients for early signs of hypopigmentation.
5.2 Eye and Mucous Membranes Irritation
Avoid contact with the eyes, mouth and other mucous membranes. If FINACEA Gel
does come in contact with the eyes, wash the eyes with large amounts of water and
consult a physician if eye irritation persists [see Adverse Reactions (6.2)].

6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates
observed in the clinical trials of a drug cannot be directly compared to rates in the clinical
trials of another drug and may not reflect the rates observed in practice.
In two vehicle-controlled and one active-controlled U.S. clinical trials, treatment safety
was monitored in 788 subjects who used twice-daily FINACEA Gel for 12 weeks
(N=333) or 15 weeks (N=124), or the gel vehicle (N=331) for 12 weeks. In all three
trials, the most common treatment-related adverse events were:
burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and
erythema/irritation (4%). In the active-controlled trial, overall adverse reactions
(including burning, stinging/tingling, dryness/tightness/scaling, itching, and
erythema/irritation/redness) were 19.4% (24/124) for FINACEA Gel compared to 7.1%
(9/127) for the active comparator gel at 15 weeks.
Table 1: Adverse Events Occurring in 1% of Subjects in the Rosacea Trials by
Treatment Group and Maximum Intensity*
FINACEA Gel, 15%
Vehicle
N=457 (100%)
N=331 (100%)
Mild
Moderate Severe
Mild
Moderate Severe
n=99
n=61
n=27
n=46
n=30
n=5
(22%)
(13%)
(6%)
(14%)
(9%)
(2%)
Burning/
71 (16%) 42 (9%) 17 (4%) 8 (2%)
6 (2%)
2 (1%)
stinging/
tingling
Pruritus
29 (6%)
18 (4%)
5 (1%) 9 (3%)
6 (2%)
0 (0%)
Scaling/
21 (5%)
10 (2%)
5 (1%) 31 (9%) 14 (4%) 1 (<1%)
dry skin/
xerosis
Erythema/
6 (1%)
7 (2%)
2 (<1%) 8 (2%)
4 (1%)
2 (1%)
irritation
Contact
2 (<1%)
3 (1%)
0 (0%) 1 (<1%) 0 (0%)
0 (0%)
dermatitis
Edema
3 (1%)
2 (<1%)
0 (0%) 3 (1%)
0 (0%)
0 (0%)
Acne
3 (1%)
1 (<1%)
0 (0%) 1 (<1%) 0 (0%)
0 (0%)

7 DRUG INTERACTIONS
There have been no formal studies of the interaction of FINACEA Gel with other drugs.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Teratogenic Effects: Pregnancy Category B
There are no adequate and well-controlled studies in pregnant women. Therefore,
FINACEA Gel should be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus.
Dermal embryofetal developmental toxicology studies have not been performed with
azelaic acid, 15% gel. Oral embryofetal developmental studies were conducted with
azelaic acid in rats, rabbits, and cynomolgus monkeys. Azelaic acid was administered
during the period of organogenesis in all three animal species. Embryotoxicity was
observed in rats, rabbits, and monkeys at oral doses of azelaic acid that generated some
maternal toxicity. Embryotoxicity was observed in rats given 2500 mg/kg/day [162
times the maximum recommended human dose (MRHD) based on body surface area
(BSA)], rabbits given 150 or 500 mg/kg/day (19 or 65 times the MRHD based on BSA)
and cynomolgus monkeys given 500 mg/kg/day (65 times the MRHD based on BSA)
azelaic acid. No teratogenic effects were observed in the oral embryofetal developmental
studies conducted in rats, rabbits and cynomolgus monkeys.
An oral peri- and post-natal developmental study was conducted in rats. Azelaic acid
was administered from gestational day 15 through day 21 postpartum up to a dose
level of 2500 mg/kg/day. Embryotoxicity was observed in rats at an oral dose of 2500
mg/kg/day (162 times the MRHD based on BSA) that generated some maternal toxicity.
In addition, slight disturbances in the post-natal development of fetuses was noted in
rats at oral doses that generated some maternal toxicity (500 and 2500 mg/kg/day; 32
and 162 times the MRHD based on BSA). No effects on sexual maturation of the fetuses
were noted in this study.
8.3 Nursing Mothers
It is not known whether azelaic acid is excreted in human milk; however, in vitro studies
using equilibrium dialysis were conducted to assess the potential for human milk
partitioning. The studies demonstrated that, at an azelaic acid concentration of 25
g/mL, the milk/plasma distribution coefficient was 0.7 and the milk/buffer distribution
was 1.0. These data indicate that passage of drug into maternal milk may occur. Since
less than 4% of a topically applied dose of 20% azelaic acid cream is systemically
absorbed, the uptake of azelaic acid into maternal milk is not expected to cause a
significant change from baseline azelaic acid levels in the milk. Nevertheless, a decision
should be made to discontinue nursing or to discontinue the drug, taking into account
the importance of the drug to the mother.
8.4 Pediatric Use
Safety and effectiveness of FINACEA Gel in pediatric patients have not been established.
8.5 Geriatric Use
Clinical studies of FINACEA Gel did not include sufficient numbers of subjects aged 65
and over to determine whether they respond differently from younger subjects.
17 PATIENT COUNSELING INFORMATION
Inform patients using FINACEA Gel of the following information and instructions:
Use only as directed by your physician.
For external use only.
Before applying FINACEA Gel, cleanse affected area(s) with a very mild soap or a
soapless cleansing lotion and pat dry with a soft towel.
Avoid use of alcoholic cleansers, tinctures and astringents, abrasives and peeling
agents.
Avoid contact with the eyes, mouth and other mucous membranes. If FINACEA Gel
does come in contact with the eyes, wash the eyes with large amounts of water and
consult your physician if eye irritation persists.
Wash hands immediately following application of FINACEA Gel.
Cosmetics may be applied after the application of FINACEA Gel has dried.
Avoid the use of occlusive dressings or wrappings.
Skin irritation (e.g., pruritus, burning, or stinging) may occur during use of FINACEA
Gel, usually during the first few weeks of treatment. If irritation is excessive or persists,
discontinue use and consult your physician.
Report abnormal changes in skin color to your physician.
To help manage rosacea, avoid any triggers that may provoke erythema, flushing, and
blushing. These triggers can include spicy and thermally hot food and drinks such as
hot coffee, tea, or alcoholic beverages.

* Subjects may have >1 cutaneous adverse event; thus, the sum of the frequencies
of preferred terms may exceed the number of subjects with at least 1 cutaneous
adverse event.
In patients using azelaic acid formulations, the following adverse events have been
reported: worsening of asthma, vitiligo, depigmentation, small depigmented spots,
hypertrichosis, reddening (signs of keratosis pilaris) and exacerbation of recurrent 2014, Bayer HealthCare Pharmaceuticals Inc. All rights reserved.
herpes labialis.
Local Tolerability Studies
Manufactured for:
FINACEA Gel and its vehicle caused irritant reactions at the application site in human
dermal safety studies. FINACEA Gel caused significantly more irritation than its vehicle in
a cumulative irritation study. Some improvement in irritation was demonstrated over the
course of the clinical trials, but this improvement might be attributed to subject dropouts.
No phototoxicity or photoallergenicity were reported in human dermal safety studies.
Bayer Healthcare Pharmaceuticals Inc.
Whippany, NJ 07981
6.2 Post-Marketing Experience
The following adverse reactions have been identified post approval of FINACEA Gel.
Manufactured in Italy
Because these reactions are reported voluntarily from a population of uncertain size, it
is not always possible to reliably estimate the frequency or establish a causal
relationship to drug exposure:
Eyes: iridocyclitis upon accidental exposure of the eyes to FINACEA Gel
6706806BS2

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CUTANEOUS ONCOLOGY

AUGUST 2014 DERMATOLOGYTIMES.COM

53

BCC:
Determining appropriate treatment strategies for locally advanced disease from page 50

A patient with multiple BCCs bordering central

SCC (previous irradiation). After treatment with
cetuximab and vismodegib, BCC had a clinical
response and SCC was stable.

A patient with nodular BCC (neglected

disease) on the chest, treated with vismodegib
and then surgery. There was histological
clearance on surgical pathology.

(Photo: Timothy Mattison, M.D.)

(Photo: Snehal P. Amin, M.D., F.A.C.M.S.)

This patients morpheaform BCC (recurrent,

multiple) of the right medial canthus, right ala
and right cheek were treated with vismodegib.
Partial response was observed and surgery
was planned.
(Photo: Snehal P. Amin, M.D., F.A.C.M.S.)

laBCC but not for treatment with oral

vismodegib.
The clinical images are a representative range of laBCC cases that
t he aut hors have encou ntered in
private practice and the treatment
c hoic e s f or e ac h . Mo s t of t he s e
cases of laBCC tend to develop in
three types of patients. A majority
of patients with laBCC have a long
histor y of incomplete t reat ments
resulting in persistent and discont inuous t umors t hat a re un li kely
to be cured by surgery alone. Some

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patients have histologically aggressive or indeterminate tumors that are

very difficult to cure as in the case of
morpheaform BCC. A few patients
have severe disease exacerbated by
neglect or limited access to medical
care.
Regardless of the factors leading to
laBCC, many patients with difficult
BCC tumors have been misinformed
that they have very limited treatment
options.
TREATMENT FOR LABCC

Published studies involving laBCC

a re l i m ited. Recent pha se 1 a nd
2 st ud ies i nvolv i ng v ismodeg ib,
however, have g reat ly ex pa nded
our understanding of the treatment
options for severe cases of laBCC. 3,4
A s h ig h l ig hted by t he t reat ment
choices for the cases listed above,
most patients with laBCC need an
individualized treatment plan with
realist ic t herapeut ic goals; many
patients undergo multiple treatments
and do not achieve histological clearance or tolerate therapy.
In addition to the size, location
and histology of the BCC, additional
c on s ide r at ion s i n c ho o s i n g t he
best treatment include the curative

This patients morpheaform BCC of the right

cheek was observed only; the patient and
family declined treatment.
(Photo: Snehal P. Amin, M.D., F.A.C.M.S.)

potential of surgery, previous therapies, tolerance of side effects, risk of

deformity, potential loss of function,
patients life expectancy and cost.
Mohs micrographic surgery, even
on recurrent and complex tumors,
offers the best chance for cure and
is the first choice of treatment for
locally advanced BCC.5 Before definitive treatment selection is made, it is
important to obtain consultations
from surgical specialties regarding
the possibility for curative resection.
If outpatient surgery with an experienced Mohs surgeon is not possible,
additional consultations with head
and neck surgeons, surgical oncologists and academic tumor boards are
essential before classifying a patient
as an inappropriate candidate for
surgery.
R ad iat ion t herapy is a second
c hoic e for l a BCC a nd c a n of t en
provide excellent cosmetic results
w it h low recu r rence rates. 6 Most
r ad i at ion onc olo g y c ent er s c a n
accommodate patients with extensive or invasive disease in difficult
locations. Patients often raise logistical concerns, citing the frequency of
treatment sessions. Dermatologists
BCC see page 54

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54

CUTANEOUS

ONCOLOGY
DERMATOLOGY

AUGUST 2014
2013 DERMATOLOGYTIMES.COM

BCC:
Determining appropriate treatment strategies for locally advanced disease from page 53
must stress the expected benefits of
radiation treatment and the limited
number of treatment sessions when
counseling patients.
ORAL HEDGEHOG PATHWAY INHIBITORS

For l a BCC pat ient s w ho a re not

surgical or radiation therapy candidates, dermatologists must consider
oral Hedgehog pathway inhibitors.
Currently, the only Food and Drug
A d m i n i s t r at ion-a ppr o v e d d r u g
indicated for laBCC is vismodegib
(Erivedge, Genentech). Due to the
clinical heterogeneity and range of
severit y of laBCC, the decision to
start systemic therapy with vismodeg ib ca n be cha l leng i ng. T he
limited amount of published data
regarding the appropriate duration
of treatment, recurrence rates after
stopping drug, combination treatments with surgery or other drugs,
presurgical or postsurgical utility,
potential persistence of subclinical
tumor islands and acquired resistance contributes to the therapeutic
challenge.
The FDA-approved label recommends continuation of vismodegib
until disease progression or intolerable tox icit y. 4 Many prescribing
dermatologists advocate discontinuation of drug once histological clearance is achieved.7
Some dermatologists have
resorted to an off-label alternating
mont h ly t herapeut ic schedu le in
order to diminish side effects. A onemonth drug holiday has been a useful
strateg y to help patients deal with
severe side effects. Once the drug
is stopped, side effects based on the
mechanism of action of vismodegib
including alopecia improve quickly.
Based on the same mechanism of
action, the potential for regrow th
of tumor cells even in histologically
cleared areas still needs to be fully
evaluated.
VISMODEGIB SIDE EFFECTS

Even though dermatologists have a

long history of prescribing systemic
medications w ith significant side
effects (i.e., methotrexate, isotretinoin, biologics), the vismodegib side
effect profile requires special atten-

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TABLE: SUMMARY OF FDAAPPROVED RECOMMENDATIONS

FOR VISMODEGIB11
Indication: Adults with metBCC, or with
laBCC that has recurred following surgery
or who are not candidates for surgery, and
who are not candidates for radiation
Dosage: 150 mg once daily
Pharmacology: 99 percent plasma protein
bound, half-life of 12 days following
single dose, mostly hepatic elimination,
undergoes minimal metabolism

monitoring for recurrence after drug

therapy.
It is important to stress that once
laBCC treatment with vismodegib
is initiated, surgery or radiation are
not contraindicated. It is unclear,
however, if v ismodeg ib is appropriate as a strategy to reduce tumor
s i z e pr ior t o s u r ger y or t o t r e at
residual tumor after surger y. The
authors currently do not recommend
combining vismodegib therapy with
surgery unless the tumor margins are
very well defined clinically.

Precautions: Embryotoxic in female

patients or female partners of male
patients, contraindicated in breast-feeding
mothers, avoid blood donation, exposure
through semen possible
Laboratory testing: None required
Pregnancy testing: Within seven days
before frst dose
Contraception guideline: Continue after
last dose for seven months for females and
two months for males
Drug interactions: P-glycoprotein
inhibitors may increase drug levels leading
to greater adverse events
A patient with morpheaform BCC of the eyelid
and temple. He was treated with visomodegib
and then Aldara, demonstrating partial
response to the visomodegib and histological
clearance after Aldara.

Common side effects: muscle spasms,

alopecia, dysgeusia, weight loss and other
GI effects
Duration of therapy: Indefnitely in
genetic cancer syndromes; stop drug
if disease progression or unacceptable
toxicity; consider four-week drug holiday

(Photo: Snehal P. Amin, M.D., F.A.C.M.S.)

tion. In addition to the embryotoxic

nature of the drug, the three main
side effects to counsel patients about
are muscle spasms, a lopecia and
taste d ist u rba nces. Even t houg h
these side effects tend to be mostly
grades 1 and 2, the discontinuation
rate for patients while taking vismodegib was approximately 50 percent,
of wh ich 15 percent was d i rect ly
attributed to adverse effects.4
Additional prescribing information for vismodegib is presented in
the table above. Regular dermatology
visits are integral to helping patients
manage side effects while on drug and

Until information about rates and

histological patterns of recurrence
if any after stopping vismodegib
is published, partially excising histologically cleared skin does not seem
logical. In our personal experience,
although presurgical vismodegib does
not reduce the diameter of the eventual surgical defect, the debulking
and thinning effect of vismodegib on
large ulcerated tumors clearly makes
the surgery simpler with respect to
blood loss, delineation of tumor, and
examination with the Mohs histopathology method.
The debulking effect (i.e., partial
response) may a lso a l low for t he
treatment of thinned tumors with
topical chemotherapies or immuBCC see page 62

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Critical Concepts on the Science

of Sunscreens
This article is brought to you by

Published as a promotional supplement to

On April 3rd, 2014, photobiologist Dr. Curt Cole led an hour-long webinar on the science of
sunscreens for Dermatology Times subscribers. Below are excerpts from that dynamic discussion.
To view the entire Webinar and Q&A session, please visit http://dermatologytimes.com/
Neutrogenasunscreenwebinar.

was introduced to sunscreens

early in my career at Temple
University when I was
conducting skin cancer
research. There, I developed
a passion to figure out how we can
make sun protection better and
I worked at Johnson & Johnson
Consumer Products Company, Inc.,
for the next 27 years to do just that.
In December 2012, the FDA made
effective the FDA Sunscreen Final
Rule. I will take you through some of
the biggest changes in the Sunscreen
Final Rule and provide scientific
insights so you can help patients
achieve optimal photoprotection.
Many people assumed the change
in the Sunscreen Final Rule led to
dramatic changes in sunscreen
products. In fact, most of the
sunscreen formulas we have on the
market today are the same ones
we had a year or two ago. What has
really changed is the way they appear
on the shelf. The labeling has new
requirements and each product must
have a new drug facts box on the
back of the package. However, one of
the biggest impacts of the changes
to the Sunscreen Final Rule is on
the definition of broad spectrum.

DERMATOLOGY TIMES

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Not All Broad Spectrum

Sunscreens Are Created Equal
In the past, many sunscreens were
labeled as broad spectrum but
they were not uniform in the level
of protection they provided. The
Sunscreen Final Rule provides a
specific test that must be performed
in order for sunscreens to be
labeled broad spectrum. The test
evaluates the absorbent properties
of the sunscreen and how broad
the protection is, requiring broad
spectrum formulas to meet a
specific critical wavelength.
To determine the critical wavelength,
you add up the sunscreens absorbance
as you move across the UV spectrum
until you reach 90% of the area under
the curve. In order to be labeled broad
spectrum, the formula must meet at
least 370 nm as a critical wavelength.
While this test method now governs
the broad spectrum claim, it really
doesnt give details about how much
protection a sunscreen provides
at each wavelength across the UV
spectrum. It is only measuring the
breadth of the protectionit does not
tell you the amplitude or how high the
protection is on the absorbent scale.
Figure 1 demonstrates this concept
of unequal protection. The curves

represent the critical wavelength

profile of two hypothetical sunscreens,
formulas that could be on the market
today. Both products A and B provide
SPF 30, with exactly the same critical
wavelength, 377 nm. However, the UVA
protection provided by the two products
is very different. The one on the left has
a UVA protection factor of 17.5; the one
on the right only has a UVA protection
factor of 3. On shelf, these sunscreens
will look and be labeled exactly the
same, SPF 30 Broad Spectrum, yet the
protection that is provided, especially
in the UVA part of the spectrum, is
very different.
The key message here is not all
broad spectrum sunscreens are equal.
In order for dermatology professionals
to recommend optimal broad
spectrum sunscreens, you need to ask
sunscreen manufacturers about the
actual UVA protection in the product.

Action Spectrum Where Is

the Damage?
Although UVA rays are more prevalent
throughout the year, UVB is still
the most damaging part of the
spectrum. Figure 2 represents the
action spectrum for sunlight. The
chart shows the action spectrum for
three different types of skin damage:

A u g u s t 2014

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Critical Concepts on the Science of Sunscreens

Figure 1. All broad spectrum sunscreens are NOT equal

Compare the 2 hypothetical, broad spectrum, SPF 30 sunscreens shown above: both have the same critical
wavelength, yet the amplitude of UVA protection varies dramatically1
The term broad spectrum does not ensure high-amplitude UVA protection
1. Data on file. Neutrogena Corp.

erythema, or sunburn, squamous

cell carcinoma, and elastosis.
You can see that, regardless of
which type of damage you are looking
at, the action spectrums are highest
in the UVB part of the spectrum,
between 290 and 300 nm. They then
drop very precipitously as we look at
the longer UVA part of the spectrum.
So, one would think all damage
is happening in the UVB, but that is
not quite accurate because the sun
spectrum shows that UVB intensity
increases sharply in that same region,
between 290 and 300 nm, and then

shows a very high level of UVA damage

throughout the rest of the spectrum.
In order to identify which
parts of the spectrum are most
important to protect against,
you have to multiply the action
spectrum by the intensity of yearround sunlight at each wavelength
to chart a damage spectrum.
Figure 3 depicts that cross
multiplication and clearly shows the
majority of the damage is coming from
UVB. The message here is that UVB
causes the highest level of damage
coming from sunlight and UVA needs

to be protected proportionately. Many

photobiologists agree the optimal ratio
of protection of UVB to UVA is about
a 3:1 ratio, a guideline mandated by
most governmental authorities in
Europe, Latin America, and Australia
for making broad spectrum claims
in those parts of the world.

Do Patients Need High SPF

Sunscreens?
The FDA has asked for data on the
clinical relevance of SPF products
that are higher than 50 to better

Figure 2. Action spectra from sunlight are very similar and highest in the UVB
Ideal Sunscreen Should Address Damage Proportionately

1. ISO 17166/CIE S007/E. 2. de Gruijl FR, Van der Leun JC. Health Phys. 1994;67(4):319-325. 3. Kligman LH, Syre RM. Photochem Photobiol. 1991;53(2):237-242.

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Figure 3. Damage spectra show need for high UVB
protection and proportional UVA protection1-3
A ratio of SPF: UVA protection of 3:1 is optimal to assure
adequate protections in both regions of the UV spectrum

1. ISO 17166/CIE S007/E. 2. J&J Data on file. 3. Cole C. Photodermatol, Photoimmunol, Photomed.
2001;17(1):2-10.

understand the value to consumers.

Its well known that increasing SPF
offers incremental changes in the
amount of UV exposure screened.
Yet its a small but mighty difference.
Its not about how much energy is
screened the important factor is
what gets through to damage the skin.
I like to explain this with what I call
the bucket theory. Figure 4 shows
sunlight going through three different
filters, one that is filtering out 96.7 of

rays, one at 98, and one at 99; this

represents the incremental differences
between SPF 30, 50, and 100 formulas.
Look at the ratio of UV exposure that
gets through: 3.3%, 2%, and 1%.
As the buckets demonstrate, the
light passing the filter is accumulating
much more quickly with the SPF
30 compared to the SPF 50, and
it takes twice as long to fill up the
bucket for the SPF 100 compared to
the SPF 50. The amount of damage

Figure 4. The higher the SPF value, the longer the required
exposure time to reach the same level of sunburn damage1

1. Ou-Yang H, et al. Poster presented at: 68th Annual American Academy of Dermatology Meeting;
March 5-9, 2010; Miami, FL.

that occurs is directly proportional

to the amount that gets through and
not the amount that is screened.
So why do we need SPF 100? Its
not just about preventing the next
sunburn. You may not have received a
perceptible redness or erythema with
your SPF 100. More importantly, you
diminished the amount of radiation
reaching your skin, causing damage
that you cannot see. Erythema
is just an endpoint for biological
damage. At the same time, there
are a lot of other things happening
under the skin that you cannot see
that are building up over a lifetime.
One of them is photo aging. We
know that the damage to the dermal
matrix builds up over time. It does not
go away. The damage accumulates
every day until you have wrinkles and
pigmented spots in the skin. If you are
able to prevent more of the UV exposure
every day then you are going to be able
to maintain younger looking skin.
Now think about this in terms of
skin cancers. The amount of radiation
that reaches the skin may eventually
trigger a skin cancer response.
Eliminating or diminishing the amount
of UV exposure to the skineven by
the incremental difference between an
SPF 50 and an SPF 100can have a
dramatic effect on how much damage
is being caused day after day for skin
aging as well as for skin cancers.
High SPF sunscreens are also
important because studies show most
patients apply only one-quarter or
one-half of the amount of sunscreen
recommended by the FDA. High SPF
sunscreens offer a margin of safety
for patients that under apply. To
understand this better, we conducted
a study where we tested various
sunscreen SPFs at four different
application densities: one-quarter,
one-half, three-quarters, and the full
amount recommended. We found the
actual SPF was proportional to the
amount that is applied. If you start
with an SPF 100 product and you put
on half as much, you will receive an
SPF 50. If you only start out with an

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SPF 30 and put on one-quarter the
recommended amount, you are going
to end up with an SPF of only 8.1

Recommending Sunscreen to
Patients
According to a study reported in the
Journal of the American Medical
Association, dermatologists
recommend sunscreen at less than 2%
of office visits.2 If were ever going to
stop the rising epidemic of melanoma
in the United States, this needs to
change. Daily sunscreen protection
should be as routine a behavior for
patients as brushing their teeth.

Q&A
Heather Onorati (Editor,
Dermatology Times): Thank you, Dr.
Cole. Our first question: What is the
significance of the application amount
of 2 mg/cm2? We know that translates
into the recommended 1 ounce of
sunscreen for your body. But how
does this translate into guidelines for
other forms like sticks and sprays?
Dr. Cole: The 2 mg/cm2 is the
magic number that has been codified
in all of the SPF testing protocols that
have been used globally. When the
FDA first started SPF testing they knew
they needed to have a standardized
application dose; 2 mg was the

smallest amount that could be applied

to the skin to be able to repeatedly
give a nice uniform thickness. So all
SPF test methods around the globe
are using this standard dose.
How does that translate into use?
For a sunscreen lotion this translates
to 1 ounce for the entire body. If you
are going to use a sunscreen stick,
pass the stick over the skin at least
3 to 4 times. For spray sunscreens,
the clue is really to spray it on until
you see the skin glisten. That way
you know you have a good solid
dose. And then take your hand and
spread it very lightly on the skin.
Onorati: Our next question is about
tanning booths. Do they have the
same exposure of UVA and UVB rays?
Dr. Cole: The tanning parlors
actually started in the 1980s when
they were primarily UVB lamps. We
then learned that was causing skin
cancers so the emphasis went toward
using only UVA lamps. Now the fact
is that the UVA lamps contain a
small amount of UVB as well. You
are still getting a tremendous load
of the UVB rays from these tanning
lamps. So together, it is just a bad
scenario. People should just avoid
tanning beds all together because of
the increased risk for skin cancers.
Onorati: Where does the FDA
currently stand on sprays and
sunscreens above SPF 50?

Dr. Cole: Over the last 5 years

spray sunscreens have become the
most popular format for sunscreens
to be sold and used; over 50% of
sunscreens in the market are spray
products. As the FDA reviews data
on the safety and efficacy of spray
sunscreens, manufacturers can
continue to sell spray products.
The second part of that question
was around SPF higher than 50. Again,
the FDA has asked for additional
data to substantiate the clinical
relevance of SPFs above 50. Can
they be demonstrably shown to be
more effective and provide a benefit
compared with an SPF 50 product?
While that data is being reviewed, they
are permitting the manufacturers to
market their products above an SPF 50.
The last piece of the monograph
is to finalize ingredients and
combinations of ingredients allowed
to be used in sunscreen formulas.

References
1. Ou-Yang H, Stanfield J, Cole C, et al. High-SPF
sunscreens (SPF 70) may provide ultraviolet
protection above minimal recommended
levels by adequately compensating for lower
sunscreen user application amounts. J Am
Acad Dermatol. 2012;67(6):12201227.
2. Akamine KL, Gustafson CJ, Davis SA, et al.
Trends in sunscreen recommendation among US
physicians. JAMA Dermatol. 2014;150(1):5155.

Dr. Curtis Cole has been involved with photobiology for more than 35 years, participating in numerous
industry collaborative initiatives in sunscreen evaluation method development. He serves as a project
leader of two international standards organizations committees developing international sunscreen
test methods and is a member of the Photomedicine Society and American Society for Photobiology.
Dr. Cole is the former Vice President of Research and Development for Johnson and Johnson Consumer
Companies, Inc. During his 27-year tenure, he has been a key contributor to several sun product
launches and innovations. Dr. Cole has 13 issued US patents and has been featured in more than
30 publications including Forbes Magazine.
A promotional supplement supported by Neutrogena. Copyright 2014 and published by Advanstar Communications Inc. No portion of this publication may be reproduced or
transmitted in any form, by any means, without the prior written permission of Advanstar Communications Inc. The views and opinions expressed in this supplement do not
necessarily reflect the views and opinions of Advanstar Communications Inc. or Dermatology Times.

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59

BRACHYTHERAPY:
Electronic surface brachytherapy provides safe, efective option for treating NMSC from page 1
not losing hair or weight like patients
with lung cancer or breast cancer.
Therefore, although traditional radiotherapy is effective for NMSC, patient
acceptance proved problematic.
Traditional radiotherapy uses large
linear accelerators to
generate radiation,
so it requires a
lead-lined fault and
heav y shielding
for patients during
t reat ment, says
Dr. Baron
Jonathan Baron,
M.D., a dermatologist and Mohs
surgeon in private practice in Santa Ana,
California. He offers electronic surface
brachytherapy for NMSC.
GREATER CONVENIENCE

Electronic surface brachytherapy

uses a portable machine (Xoft Axxent
Electronic Brachytherapy System;
iCAD) about the size of a laser to
generate radiation that physicians
apply through an applicator placed
directly on the skin. Each treatment
takes about three minutes the same
amount of time as traditional radiotherapy, but with much less shielding
required, Dr. Werschler says.
With the new technology, We are
able to deliver precise, accurately
targeted doses with little if any
excess radiation delivered to the
surrounding skin, Dr. Baron says.
And because radiation oncologists
are truly the experts in utilizing
radiation to treat all forms of cancer,
we rely on them to come up with
the appropriate treatment regimen
for each patient. It truly is a collaboration between the dermatologist
and the radiation oncologist.
The dermatologist biopsies the
lesion and educates the patient about
treatment options, Dr. Werschler says.
If the patient chooses brachytherapy
or wishes to learn more about it, the
patient meets with a radiation oncologist, who ultimately oversees the
treatments, which are performed by a

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QUICK READ
For selected nonmelanoma
skin cancers, electronic
surface brachytherapy offers
advantages including a high
cure rate and a patient-friendly
regimen, proponents say. But
expert opinions are divided
as to its ultimate role in the
dermatologists ofce.
radiation therapist (using doses calculated by an off-site medical physicist)
in the dermatologists office, he says.
The procedure is noninvasive and
painless, and clinically proven to be
effective, says Ken Ferry, president
and CEO of iCAD. The mobile design
of the system allows dermatologists to
offer this unique treatment option to a
broader patient population and position
their practice as an innovative leader in
their community.
Most dermatology practices offering
this procedure have a radiation oncologist on-site two days weekly, performing
consultations and monitoring treatment,
according to Dr. Baron.
Patients have a comfort level with
that, because theyre familiar with your
office, and they know the staff and
how to get here. We used to have to
send these patients to the hospital for
treatment, he says.
FAST TREATMENTS

Because treatments are quick, the

radiation oncologist who visits his office
can do 10-plus treatments daily, Dr.
Werschler says.
Ten or more Mohs cases is a very
long, busy day for a dermatologist. And
the radiation oncologists can do this
every day, without fatigue. Thats not
the case in Mohs surgery, he says.
In radiation oncology offices and
integrated cancer centers, Dr. Werschler
says, electronic brachytherapy equipment
can run virtually 24-7.
Its a very different, and very
patient-friendly model, whereas I
do Mohs surgery one or two days
weekly, he says. If you cant come

in on those days, I probably cant treat

you without significantly rearranging
the clinic schedule.
The only downside to electronic
brachytherapy is that patients must
undergo usually eight to 10 treatments,
versus one for Mohs surgery, says Kavita
Mariwalla, M.D., a Mohs surgeon in West
Islip, New York who refers patients to a
nearby radiation oncologist for electronic
surface brachytherapy. Electronic brachytherapy also results in some crusting,
redness and irritation, which she says
resolve in a few days.
Electronic surface brachytherapy may
result in hypopigmentation and possibly
permanent hair loss in the treatment
area, Dr. Baron says, but older men
the prime demographic of NMSC
dont much mind the latter.
TUSSLING FOR TURF?

The fact that radiation oncologists

and integrated cancer centers are
marketing electronic surface brachytherapy for skin cancer treatment
raises a very interesting political,
economic and scope of practice issue
going forward, Dr. Werschler adds.
Der matolog ists
ne e d r ad i at ion
oncolog ists to
perform the
t reat ment, he
explains. However,
Radiation oncologists dont need a
dermatologist.
Dr. Werschler
A s a der matologist or Mohs surgeon evaluating
electronic surface brachytherapy, Dr.
Werschler asks, Do you embrace a
competing technology and incorporate
it into your practice as part of the
spectrum of comprehensive skin cancer
care offered in the dermatology office?
Or do you fight it, ignore it, delay it, even
demean it? Ive seen all that happening,
and heard it in personal conversations.
Whenever that happens, he says,
Im thinking to myself, Its not my
choice. Its my patients choice, after the
BRACHYTHERAPY see page 60

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BRACHYTHERAPY:
Electronic surface brachytherapy provides safe, efective option for treating NMSC from page 59
risks and benefits of the procedure are
fully explained.
Dermatologists who instead seek
to guard their NMSC turf one day
could find that most skin cancers are
being treated by radiation therapy
not in the dermatologists office, but
in the radiation oncologists office or
comprehensive cancer center, Dr.
Werschler says.
As a specialty, Organized dermatology needs to make a decision how
theyre going to approach this. You dont
want to be the guy whos still championing carburetor technology in the
world of electronic fuel injection.
According to an American Academy
of Dermatology (AAD) position paper
approved in late 2013, the academy
considers surgical treatment (e.g.,
excision, Mohs, destruction) the optimal
primary intervention for basal cell
carcinoma (BCC) and squamous cell
carcinoma (SCC). Moreover, the paper
raises the concern that the rapid growth
in utilization of temporary current
procedural terminology (CPT) codes
related to superficial radiation therapy
and electronic surface brachytherapy
may draw scrutiny from private payers,
federal agencies, including the Centers
for Medicare and Medicaid Services,
members of Congress, and federal
watchdogs.
Presently, the paper states, The
academy believes additional research
is needed on superficial radiation
therapy (SRT) and electronic surface
brachytherapy.
DERMS VERSUS RADIATION ONCOLOGISTS

Mark S. Nestor, M.D., Ph.D., says he

shares Dr. Werschlers concern about
dermatology losing NMSC treatments
to radiation oncology not necessarily
due to brachytherapy, but due to radiation
therapy in general. He is a voluntary
associate professor, department of dermatology and cutaneous surgery, University
of Miami Miller School of Medicine.
Dr. Nestor performs SRT for NMSC
in his office. He says he understands
radiation oncologists treating skin cancer
because cancer treatments are what
they do. However, Almost all radiation

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oncologists use electron beam therapy

to treat skin cancers, which has been
shown to be less effective and have more
side effects than SRT. Additionally, where
I have an issue is that there are some
in the dermatologic community who
look at radiation therapy as a conflict or
encroachment on Mohs surgery, which
is ridiculous.
Many of the dermatologists performing
SRT for skin cancers are Mohs surgeons,
he says.
Mohs is still utilized on certain
tumors; radiation therapy is utilized on
certain tumors, Dr. Nestor says. Theyre
both choices that patients should have.
Compared to electronic surface
brachytherapy, he says, SRT has much
more data and behind it at this point.
It was developed by dermatologists, and
it is being embraced more by dermatologists who, with proper training,
can perform
t he procedu re
without radiation
oncologists.
Ajay Bhatnagar,
M.D., author of the
longest study of
electronic surface
brachytherapy for
Dr. Bhatnagar
NMSC to date, says
electronic surface brachytherapy is a
new modality. We need more follow-up
to establish the long-term results. But
the current short-term results are highly
encouraging, and very comparable to
traditional brachytherapy.
Among 277 patients treated with
the new modality, no recurrences
have occurred during follow-up that
ranged from one to 51 months (mean:
13 months) post-treatment (Bhatnagar
A. AAD 72nd Annual Meeting. March
21-25, 2014. Denver). He is medical
director of 21st Century Oncology of
Arizona, practicing radiation oncology in
Scottsdale, and Casa Grande, Arizona;
and an adjunct assistant professor of
radiation oncology at the University of
Pittsburgh, Pennsylvania.
COEXISTING PEACEFULLY?

Going forward, most sources say, the

NMSC landscape is large enough to

accommodate electronic surface brachytherapy, Mohs surgery and other existing

treatment options. Dr. Bhatnagar says
that while researchers including himself
are currently establishing the role of
brachytherapy including electronic
brachytherapy as a viable option for
NMSC for a specific subset population,
The majority of NMSCs will be treated
by surgery, Mohs or otherwise.
Dermatologists who offer electronic
brachytherapy are not trying to replace
Mohs surgery, which will remain the
gold standard for most NMSC, Dr.
Baron says. Were just trying to have
another option for patients who may not
be candidates for Mohs surgery or who
have lesions in cosmetically sensitive or
anatomically challenging locations.
Dr. Mariwalla adds that with the
epidemic of skin cancer in the United
States, I dont believe that treating
all skin cancers with radiation will be
something patients want.
I dont believe radiation oncologists
are going to start treating only skin
cancers, Dr. Mariwalla says. They have
many other types of cancers to deal
with. For the number of skin cancers
out there, I dont believe electronic
surface brachytherapy is such a threat.
Skin cancer treatments make up
about 30 percent of Dr. Bhatnagars
practice, which he says is atypically
high for a radiation oncologist.
The bottom line is that in terms of
safety and efficacy for NMSC, Theres
never been a challenge to Mohs, Dr.
Werschler says. In my opinion, we now
have an alternative therapy. Whereas
traditionally patients with skin cancer
on the face, hands or legs or with
high risk of recurrence generally chose
Mohs surgery, now they have a credible
choice. So you explain the risks and
benefits of the procedure and let them
make their decision. DT
Disclosures: Dr. Bhatnagar is a consultant and principal investigator for iCAD and has received research
funding from the company. Dr. Nestor is a consultant
and advisory board member for Sensus Healthcare
and has received research grants from the company.
Drs. Baron, Werschler and Mariwalla use the Xoft
system but report no financial interests in iCAD.

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BCC:
Determining appropriate treatment strategies for locally advanced disease from page 54
Hedgehog pathway inhibitors, such
as sonidegib, are currently undergoing trials and could potentially
offer improved side effect profiles,
increased efficacy or even decreased
resistance potential. 8
Potent ia l hedgehog pat hway
inhibitors such as itraconazole and
arsenic trioxide may play an important role in treatment of vismodegib
resistant tumors.9 Additionally, topical
smoothened inhibitors under current
study may be useful in cases where oral
vismodegib is not tolerated.10
F u t u r e a r t ic l e s i n t h i s s e r i e s
regarding aBCC will review the current
state of research as well as the impact
and management of aBCC in elderly
patients.
T he int roduct ion of new t reatments for metBCC and laBCC was a
pivotal development in dermatology,
translating basic science in to clinical
practice. The focus on laBCC represents an important opportunity for
dermatologists to continue their role
as skin cancer experts. DT

Involves vital
structure
Multiple
recurrences

Extensive/
invasive
tumor

High risk
location

Locally
advanced
BCC

High tumor
burden
(Gorlins)

Surgical
candidate?

Consider Mohs or wide local excision

Curative resection likely?
Risk of deformity or loss of function?

Radiation
therapy
candidate?

Risk of signifcant morbidity?

Previous radiation therapy?
Consider surgery + radiation

Hedgehog
pathway
inhibitor
candidate?

Continue until disease progression

or intolerable toxicity

Disclosures: Dr. Krishnan reports no relevant financial interests. Dr. Amin has participated on the advisory board for Genentech and is a paid speaker.

Consider surgery + vismodegib

References:
Combination
chemotherapy
candidate?

Tumor board or medical oncology

i.e. cisplatin and cetuximab

1. von Domarus H, Stevens PJ. J Am Acad

Dermatol. 1984;10(6):1043-1060
2. Mohan SV, Chang ALS. Curr Dermatol Rep.
2014;3:40-45

Figure 1 demonstrates an algorithm for identifying and treating locally advanced basal cell carcinoma.

4. Sekulic A, Migden MR, Oro AE, et al. N Engl

J Med. 2012;366(23):2171-2179

(Source: Snehal P. Amin, M.D., F.A.C.M.S.)

nomodulators even if v ismodegib

does not clear the histological tumor.
LABCC AND ROLE OF THE DERMATOLOGIST

Most patients with laBCC have long

and complicated clinical courses
with visits to multiple dermatologists, surgeons and other specialists. When they do arrive in the next
dermatologists office, it is important
not to simply refer these patients to
another specialist.
We believe that the dermatologist
should play the central role in the
care of patients w ith laBCC. Even
though most general dermatologists
will not be performing a wide local

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3. Chang ALS, Soloman JA, Hainsworth JD, et

al. J Am Acad Dermatol. 2014;70(1):60-69

excision or Mohs surger y in t heir

office for these laBCC patients, all
dermatologists, by the very nature
of their diverse training and practice, understand both medical and
surgical options as well as radiation
therapy.
In addition, dermatologists are
best posit ioned to cl i n ica l ly a nd
histopathologically monitor patients
with laBCC regardless of their treatment course with regular skin exams
and full thickness skin biopsies.
I n t he ne x t fe w yea r s, se ver a l
new topical and systemic agents as
well as novel imaging techniques
w i l l become ava i lable. New ora l

5. Chren MM, Linos E, Torres JS, et al. J Invest

Dermatol. 2013;133:1188-1196
6. Avril MF, Auperin A, Margulis A, et al. Br J
Cancer. 1997;76(1):100-106
7. Ibrahim SF. The Dermatologist.
2014;22(3):32-34
8. Petrou I. DermatologyTimes. http://dermatologytimes.modernmedicine.com/dermatology-times/news/smoothened-inhibitors-provide-new-options-bcc-treatment. Accessed
June 26, 2014.
9. Kim J, Aftab BT, Tang JY, et al. Cancer Cell.
2013;23(1):23-34
10. Skvara H, Kalthoff F, Meingassner JG, et al.
J Invest Dermatol. 2011;131(8):1735-1744
11. Lyseng-Williamson KA, Keating GM. Am J
Clin Dermatol. 2013;14(1):61-64

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Margin comments in nevi histology

reports impact re-excision rates
Ilya Petrou, M.D. | Senior Staff Correspondent

Panama City, Panama Histological reports on atypical or dysplastic

nevi that include margin comments
appear to have a significant impact on
how the clinician will proceed regarding
the potential re-excision of lesions,
according to a recent literature review.
The literature has begun in a more
scientific way to back up what we have
already been doing in practice for the last
15 to 20 years regarding dysplastic nevi.
It appears that dermatologists have been
intuitively treating and managing these
potentially dangerous lesions correctly,
underscoring the safe medicine practiced by clinicians, says Richard L.
Spielvogel, M.D., Dermpath Diagnostics,
Newtown Square, Pa.
In a recent study, researchers investigated the value of margin comments
used in dermatopathology reports on
dysplastic nevi and how they can influence re-excision rates. The retrospective
study included 584 histopathologically
dysplastic nevi, of which 302 had margin
comments in the histology report and
282 did not. Results showed that re-excision was performed at a significantly
higher rate in those patients who had a
report without margin comments (51.8
percent) compared to patients where
margin comments were included in the
report (39.4 percent).
According to the study, the difference
was observed among those nevi that
were diagnosed as mildly to moderately
dysplastic, but not for severely dysplastic
nevi. Apart from the direct impact of
potentially reducing the rates of re-excisions, the authors concluded that use of
margin comments can also help reduce
healthcare costs and morbidity (Comfere
NI, Chakraborty R, Peters MS. J Am Acad
Dermatol. 2013;69(5):687-692).
RE-EXCISION DECISION

Another study looked at the long-term

outcomes of patients with histologically dysplastic nevi that approached a
microscopic specimen border (within
0.2 mm) but were not re-excised. It
questioned whether or not there was an
increased risk for the lesions to further
develop into a melanoma (Hocker TL,

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QUICK READ

DIAGNOSTIC DIFFERENCES

A recent literature review

indicates that histological reports
on dysplastic nevi that include
margin comments infuence the
rates of re-excision, underscoring
the value of margin comments
in dermatopathology reports.
Alikhan A, Comfere NI, Peters MS. J Am
Acad Dermatol. 2013;68(4):545-551).
The retrospective study included a
total of 115 patients who were followedup for an average of 17.4 years. Of the
115 nevi included in the study, 66, 42
and seven nevi had mild, moderate and
severe dysplasia, respectively. Results
showed that none of the patients developed metastatic melanoma or melanoma
at the site where the dysplastic nevus was
originally removed, despite the fact it
closely approached a margin.
Both of these studies indicate that
clinicians do not necessarily have to
routinely re-excise dysplastic nevi that
were incompletely or narrowly removed,
particularly those nevi with only very
mild or moderate atypia. However, those
nevi exhibiting severe atypia should be
re-excised, Dr. Spielvogel says.
The excision and/or re-excision of
severely dysplastic nevi is still recommended Dr. Spielvogel said, because of
the possibility that they could further
develop into a melanoma. Moreover,
severely atypical lesions cannot be reliably distinguished from melanoma in all
instances, and they should be removed
just to be on the safe side. In practice, Dr.
Spielvogel said that some dermatologists
may prefer to also re-excise moderately
dysplastic nevi that have been incompletely or narrowly removed however,
that would be an individual decision.
Regardless of the pathology report,
if a lesion looks severely unusual or
atypical on clinical presentation, it
should be completely removed with a
clear margin, Dr. Spielvogel says. It is
important to remember that pathology
consists of both a gross, which only the
dermatologist sees, and a pathologic,
which only the pathologist sees. If either
one appears severely atypical, that could
be an overriding factor and the lesion in
question should be completely removed.

I n a not her re t r o s p e c t i v e s t ud y,
researchers evaluated the effect of
surgical excision performed after the
biopsy-diagnosis of dysplastic nevi, in
terms of the final diagnosis, melanoma
prevention and melanoma detection
(Reddy KK, Farber MJ, Bhawan J, et al.
JAMA Dermatol. 2013;149(8):928-934).
Of the 580 dysplastic nevi included in
the study, 196 had a positive biopsy
margin increasing with grade of atypia;
127 of the 196 lesions (65 percent) were
re-excised, performed more often as the
grade of atypia increased.
Data showed that two of the 127
re-excised lesions received a different
diagnosis, changing from biopsydiagnosed moderately to severely
dysplastic nevus to melanoma in situ.
The researchers also found that of the
216 melanomas included in the study, in
situ and superficial spreading subtypes
were more of ten associated w it h
histopathologically dysplastic nevi (20
percent and 18 percent, respectively),
most of them having a moderate-tosevere grade of atypia.
The excision of biopsy-diagnosed
mildly or moderately dysplastic nevi
will not likely result in a clinically
sig n i f ica nt cha nge i n d iag nosis,
Dr. Spielvogel say s, a nd t he r isk
of transformation of these lesions
t o me l a nom a app e a r s v er y lo w.
However, as moderately-to-severely
and severely dysplastic nevi are more
often associated with melanoma, their
timely excision may be prove to be
beneficial for the detection or prevention of melanoma.
There has been a lot of controversy on atypical or dysplastic nevi
regarding their appropriate treatment
and management. I think that despite
the lack of literature in the past, it
looks like most practicing dermatologists have come to some good conclusions regarding when to re-excise the
lesion, and which types of lesions (in
terms of their atypia) to re-excise, as
reflected in these recent studies, Dr.
Spielvogel says. DT
Disclosures: Dr. Spielvogel reports no relevant
financial interests.

ES468523_DT0814_064.pgs 07.23.2014 04:29

ADV

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sawresults within 1 hour; N=28.

Study results for once-daily application of Neotensil in a 2-week pilot study; N=25.
References: 1.Data on fle, Living Proof, Inc. 2.Draelos ZD, Investigator. Strateris 16-hour durability study, DCS-105-13. Data on fle, Living Proof, Inc.
3.Kauvar A, Kilmer S, Ross EV, et al. A pilot study of a novel non-invasive topical under-eye contouring technology. Poster presented at: 71st Annual
Meeting of the American Academy of Dermatology; March 1-5, 2013; Miami, FL.
Neotensil and Living Proof are trademarks of Living Proof, Inc. used under license.
Except as otherwise indicated, all other product names, slogans and other marks are trademarks of the Valeant family of companies.
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2014 Obagi Medical Products, Inc., a division of Valeant Pharmaceuticals North America LLC. DM/NEO/14/0008c 03/14

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ES467143_DT0814_065_FP.pgs 07.18.2014 23:01

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66

BUSINESS OF DERMATOLOGY

AUGUST 2014 DERMATOLOGYTIMES.COM

OUTREACH EFFORTS
69 Strengthen
your role in the
population you serve by
connecting with the community

FAN ENGAGEMENT
71 BOOST
Increase interaction on Facebook
by hosting video events and
offering contests, giveaways

ACO, health insurance

exchange pressures mounting
John Jesitus | Senior Staff Correspondent

QUICK READ

National report As healthcare

Dermatologists must remain

engaged, informed and proactive
in documenting the value
that their services provide
to managers of insurance
exchanges and accountable care
organizations, experts say.

reform advances, experts say, dermatologists face mounting pressure to prove

their mettle to insurance exchanges and
accountable care organizations (ACOs).
Jack Resneck
Jr., M.D., defines
a healthcare
exchange as a tool,
usually a website,
that individuals or
small businesses
(which the Affordable Care Act/ACA
Dr. Resneck
defines as having
fewer than 50 employees) use to choose
a healthcare plan. Dr. Resneck is associate professor and vice chairman of
dermatology, Philip R. Lee Institute
for Health Policy Studies, University
of California, San Francisco, School
of Medicine, and a member of the
American Academy of Dermatology
(AAD) board of directors.

Quotable
If you have a particular
condition that you dont
want shared, providers
are going to look at their
policies and see what
they can accommodate.
Mary Griskewicz
Health Information
Management Systems Society

On data exchange
and patient consent
See story, page 78

Although only some dermatologists currently participate in healthcare exchange plans, he says, Whats
happening in the exchange plans
will be spreading to other commercial insurance products, not at the
gover n ment s behest, but due to
insurers desires.
As of mid-April, 8 million Americans
have signed up for state and federally run
private insurance exchanges, published
accounts say. Generally, Dr. Resneck
adds, most Americans chose the lower
premium Bronze or Silver level plans,
which cover the same services as Gold
plans but include higher deductibles
and copays.

But while these higher deductible

plans may be right for many patients,
they dont always realize what they
are buying, he says. They sometimes
think they have first-dollar healthcare
insurance. Then they come to your
office, have a visit or biopsy, and have
to pay 100 percent of your negotiated
rates with their insurer until they hit
that high deductible. Whos going to
be the first to absorb that frustration
after they get that bill? Often its you
and your office staff.
NARROW NETWORKS

Other exchange elements proving

troublesome for dermatologists include
narrow networks and their ramifications, Dr. Resneck says.
For starters, he explains, few dermatologists have joined exchanges at the
sharply discounted payment rates
offered by insurers. Therefore, some
insurers are using contractual all products clauses to boost their networks.
PRESSURE MOUNTING see page 76

DTExtra
Despite the proliferation of physician ratings
websites in recent years, more Americans still rely
on information from friends and family members
when choosing a doctor, according to a new survey.
The study found that among those (23 percent) who
have gotten information comparing healthcare
providers quality in the past year, two-thirds got
it from friends or family. Other survey findings: 48
percent said it is either very easy or moderately
easy to find trustworthy information about the
quality of care provided by local doctors; 47 percent
said they are extremely confident they could
find information to help in selecting a specialist.
READ MORE: MEDICALECONOMICS.COM/QUALITYDOCTORS

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ES474088_DT0814_066.pgs 07.29.2014 04:30

ADV

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Proven EFFICACY
in step with

Skin restoration
Only ECOZA FOAM combines the
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Kills fungi that cause interdigital
tinea pedis1
Unique foam delivery system helps
protect and restore skin2-4
Convenient once-daily dosing1
Nongreasy foam penetrates quickly,
dries rapidly5
Alcohol-free1
INDICATIONS AND USAGE
Ecoza (econazole nitrate) topical foam, 1%, is indicated
for the treatment of interdigital tinea pedis caused by
Trichophyton rubrum, Trichophyton mentagrophytes,
and Epidermophyton floccosum in patients 12 years of
age and older.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
Flammability: Ecoza topical foam is flammable. Avoid
heat, flame, and smoking during and immediately following
application. Contents under pressure.
ADVERSE REACTIONS
Clinical Trials Experience: During clinical trials with Ecoza
topical foam, the most common adverse reactions were
application site reactions which occurred in less than 1%
of subjects in both the Ecoza and vehicle arms.
DRUG INTERACTIONS
Warfarin: Concomitant administration of econazole and
warfarin has resulted in enhancement of anticoagulant effect.
Most cases reported product application with use under
occlusion, genital application, or application to a large body

surface area which may increase the systemic absorption of

econazole nitrate. Monitoring of International Normalized Ratio
(INR) and/or prothrombin time may be indicated especially for
patients who apply econazole to large body surface areas, in
the genital area, or under occlusion.
Please see Brief Summary of full Prescribing
Information on adjacent page.
References: 1. Ecoza [prescribing information]. Jamison, PA: Quinnova
Pharmaceuticals, LLC; 2013. 2. Ghadially R, Silvander M. Penetration study
results using proderm technology foam. Poster presented at: 7th Annual
Caribbean Dermatology Symposium; January 15-19, 2008;
St. Thomas, US Virgin Islands. 3. Fowler JF Jr. Efficacy of a skin-protective
foam in the treatment of chronic hand dermatitis. Am J Contact Dermat.
2000;11(3):165-169. 4. Man M-Q, Feingold KR, Thornfeldt CR, Elias PM.
Optimization of physiological lipid mixtures for barrier repair. J Invest Dermatol.
1996;106(5):1096-1101. 5. Kircik LH, Bikowski JB. The science of topical foam
formulations. Pract Dermatol. 2012;9(1):S1-S16.

NEW

(econazole nitrate)
topical foam, 1%
www.EcozaFoam.com
2014 QUINNOVA Pharmaceuticals, LLC.

Jamison, PA 18929

(877) 660-6263

All rights reserved.

KILL FUNGUS. RESTORE SKIN.

01/14

ECO013B

www.QUINNOVA.com

AUGUST 2014 DERMATOLOGYTIMES.COM

BUSINESS OF DERMATOLOGY

69

Melanie D. Palm, M.D.,

is director of Art of
Skin MD in Solana
Beach, Calif.

Celebrate the community

while strengthening your practice
When was the last time you got really
excited about dermatology? I mean,
in your bones, core-shaking, vitalityrestoring, conquer the universe type
of elation. If the answer is Well, I cant
remember the last time. or worse yet,
Maybe never? then perhaps it is time
to throw a party.
No, no, its not what you think. Im
talking about a derm-centric celebration where you choose the cause. In
the process you will find it renews
your motivation for this career in
medicine, gives back to the community, and galvanizes a collective effort
amongst your staff in the process. Best
yet, it can be fun!

your associates enjoy and practice

during your clinic day. A re you a
Mohs su rgeon w it h f i nely t u ned
surgical expertise? Are you a laser
surgeon with the ability to treat scars
or tattoos? Are you a medical dermatologist with a passion to educate the
public on changing moles or sk in
cancer? Or are you perhaps a pediatric dermatologist with a desire to
educate parents on their childrens
skin condition? All of these are examples of duties we perform on a daily
basis that could easily be converted
to an altruistic means of serving the
citizens of your town or city.

Media opportunities
raise awareness
for the cause and
solidify you and
your practice as
the epicenter of
expertise.

My advice is to start small and let it

grow organically. I started four years
ago during the month of May. I was
interested in raising awareness about
skin cancer prevention and detection in a sunny coastal community
that often yielded actinic keratoses in
20-year-olds and basal cell carcinomas
in 30-year-olds. The first year had very
humble beginnings: Four skin cancer
screenings at local gyms and athletic
apparel shops.
The following year was skin cancer
screenings at a local spa followed
by a silent auction and happy hour,
with proceeds benefiting skin cancer
research. The last two years efforts
and realization of this community
event now termed SolSearch have
g row n ex ponent ia l ly. This yea rs
event was replete with a skin cancer
s c r e e n i n g e v e nt i n v ol v i n g f ou r
dermatologists and a party with 200
guests, a live band, locally sponsored
organic food and drinks, and over
$15,000 i n proceeds towa rd sk i n
cancer research.
Doing good feels good. Doing good
is interesting and also gets noticed.

START SMALL, BUILD UP

Yes, we are all ever pressed for

time. Providing precious time and
resources may seem incong ruent
with a healthy bottom line for the
p r a c t ic e . Ho w e v e r, c om mu n i t y
out reach ef for ts st reng t hen your
role i n t he popu lat ion you ser ve
and often lead to intangible, longlasting, and positive effects for your
practice perception.
Getting started with community
out reach related to your pract ice
does not need to start off as a swanky
soiree. Ta ke stock of what you or

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T he med ia of ten t a kes not ic e of

work well done by physicians. Media
oppor t u n it ies whet her rad io, T V
or print is an excellent way to raise
awareness for the cause and solidify
you and the practice as the epicenter
of expertise.

Community
outreach efforts
strengthen
your role in the
population you serve.
If you feel as though party planning is not in your future, there are
many other opportunities to lend
your ex per t ise for a cause. Loca l
dermatologic societies and national
dermatologic organizations often
organize sk in cancer or pediatric
events that make your time investment m i n i ma l a nd you r posit ive
attitude return high.
Want to do something more unique
and sustainable within your practice?
Then ident if y unmet communit y
needs a nd you r u n ique sk i l l set.
Next, see where these two intersect
and voil your idea for community
outreach is born.
Chambers of commerce and local
charity groups are an excellent place
to star t. If your idea is unique, it
may be suppor ted by communit y
grants through local and national
der matolog ic orga n i z at ions. My
adv ice is to follow your interests,
support the outcome and watch it
grow. The fruits will be well worth
your effort. DT

ES474921_DT0814_069.pgs 07.29.2014 23:46

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70

BUSINESS

OF DERMATOLOGY

AUGUST 2014 DERMATOLOGYTIMES.COM

Tim Sawyer is president

and co-founder of Crystal
Clear Digital Marketing

Novel technology system allows clinicians

to increase connectivity with patients
As a medical professional in the
field of dermatology your time is valuable. So the million-dollar question
is: Beyond providing quality care for
your patients and relying on voluntary
referral sources, how you can maximize the potential of your practice?
And by maximize, I am speaking in
terms of patient satisfaction and practice revenue. Fortunately, there is an
emerging technology ecosystem that
offers dermatologists and aesthetic
prac t it ioners t he oppor t u n it y to
strengthen patient connectivity (satisfaction) while improving the financial
performance of the practice.
What does this have to do with your
practice? Everything. Consider this:
41 p e r c e nt of p a t ie nt s w ou ld
consider switching their doctor
each year for a doctor with better
technolog y (website, communication, scheduling, etc.). Fifteen
percent actually switch;
87 percent of U.S. adults use the
Internet (January 2014 survey. Pew
Research);
90 percent of U.S. adults own a cell
phone;
58 percent of U.S. adults own a smartphone (January 2014 survey);
72 percent of Internet users say they
looked online for health information
within the past year;
77 percent of online health seekers
began their last session at a search
engine such as Google, Bing or Yahoo.
In many cases these patients are
looking to be more actively engaged
in their health, wellness and aesthetic
plans. This poses a tremendous opportunity for creative patient focused
practices to engage their patients more
effectively and efficiently, increase
calendar density and enhance overall
patient satisfaction.
DIGITAL COMMUNICATION PLAN

Modern medical practices will need

to implement well-executed digital

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communication plans focused on

sending the right message at the right
time in the way the patient wants to
receive it with the ultimate goal of
improving wellness, satisfaction and
practice stability.
Its all about understanding the
current technology ecosystem and the
application to your practice.
The ecosystem applies to each step
in the patient engagement cycle. And
one affects the other, from the time a
new patient searches for you on Google
or Facebook, to the check-in process
including the paperwork, to the office
visit, post-visit, treatment and beyond.
Online visibility is an important part
of the ecosystem. It not only affects a
new patients ability to find you, but also
reflects your brand, your place in the
community, your accomplishments,
first impression and a place for existing
patients to share their experience.
Online visibility includes search such
as Google, Yahoo, Bing, Yelp, directories,
social media outlets, etc. All roads lead
to your site (or at least they should). This
is your virtual medical office, likely the
No. 1 medium for a first impression.
CRUCIAL QUESTIONS

When was the last time you reviewed

your website? Does it accurately reflect
to the world your years of education,
training and expertise? Are there welldesigned video elements, a current
blog? W ho is responsible for t his
powerful branding/marketing tool and
who is responsible to keep it current?
Are you using a patient management
tool as a way to track and automate
communication with your patients via
text, email and voice? This communication could be related to a specific
condition such as rosacea or as a way
to promote aesthetic services to your
traditional dermatology patients.
The new technology ecosystem for
modern dermatology practices should
include the following:

Mobile responsive Web technology

that allows your practices website
to be viewed on any device;
P rofe s sion a l on-page c ontent
providing the reader with practical
information written in a way that
does not require a medical background to understand;
A frequent ly updated blog
promoting the practice as well as
important treatments and procedures offered;
A strong professional social media
presence to humanize the practice
and increase connectivit y w ith
future, present and past patients;
A patient management tool beyond
the traditional EHR/EMR to automate effective communication with
future, present and past patients;
Software and methodology to track
performance across all marketing
mediums.
Successful utilization of this technology ecosystem begins with the fundamental understanding that deficiency
in any part of the system will result in a
diminished capacity of the entire system.
In other words, one part affects another.
In a 24/7 connected world emerging
technology ecosystems can help you:
Connect with patients (new, existing
and previous);
Strengthen your connection (add
value to them and your practice);
Stay connected longer and increase
referral potential (through increased
satisfaction and wellness).
As medical professionals look for
sustainable ways to maintain their practices beyond quality care and voluntary
referrals, the Internet offers an incredible
opportunity to find, serve and keep more
satisfied patients profitably.
Innovation has always been an
impor ta nt pa r t of t he hea lt hca re
landscape. Connectivity, loyalty and
motivation are all important factors
in sustaining patient populations and
practice stability. DT

ES468374_DT0814_070.pgs 07.22.2014 23:56

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AUGUST 2014 DERMATOLOGYTIMES.COM

BUSINESS OF DERMATOLOGY

71

Patricia Redsicker is a healthcare

content marketing consultant
and principal at Wordview
Editing in Baltimore

Engage your patients on Facebook

Do you want fresh ideas to quickly
ramp up Facebook engagement and
participation from your fans?
Here are a few ways to create better
engagement on your page:
Post news articles, stories
and current events
Facebook gives more visibility to interesting news articles, story links and
current events.
Posting attention-grabbing skincarerelated articles from news publishers, or
compelling stories from your own blog
will help to create conversation among
your fans and clients.
If you can achieve that, your Facebook
posts will be bumped higher up on your
fans news feeds and engagement will
increase significantly.

Host video events

Live video events are a fun way to

increase engagement with fans. You
can do this easily by installing a free
app such as Livestream (go to https://
apps.facebook.com/livestream/).
The chat feature on Livestream
makes it interactive. So lets say you
want to introduce a new sk incare
system. Using the app, you can host an
event on your Facebook page to show
fans how the program works. They can
see you, ask questions and interact with
you right there!
Offer contests, giveaways

Everyone loves the opportunity to

win something special.
Consider a photo contest where

you a s k f a n s to s ubm it pic t u re s

of t hemselves, before and af ter
receiv i ng t reat ment f rom you r
dermatolog y practice. Use a photo
contest app such a s St r ut t a t hat
allows fans to upload their pictures.
Then encourage them to tell their
friends about the contest and open
the voting up to everyone who has
submitted a photo.
A few things to watch out for when it
comes to Facebook contests follow
the rules; keep the contest requirements simple; and offer a special prize
thats relevant to your practice. DT
For more tips on engaging patients using
Facebook, visit: dermatologytimes.com/
engagepatients

Best optics. Best lighting. Best design.

Designed by doctors
for doctors.

dermatoscope
www.canfieldscientific.com
info@canfieldsci.com
phone +1.973.276.0336
(USA) 800.815.4330

VEOS is a registered trademark of Canfield Scientific, Inc.

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patent pending

ES467487_DT0814_071.pgs 07.21.2014 20:21

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72

BUSINESS

OF DERMATOLOGY

AUGUST 2014 DERMATOLOGYTIMES.COM

Christopher Jarvis, M.B.A., C.F.P., is a former actuary,

the co-founder of the Daktori Financial Fellowship
(www.daktori.com) and author of 12 financial books
for physicians. Michael S. Berry, Ch.F.C.

Innovative techniques
for protecting your home
Along with retirement accounts,
the family home is often the most
valuable asset of the affluent. Beyond
its financial value, the home has great
psychological and emotional value. In
fact, we find that most of our clients
who engage in asset-protection planning often begin with the question:
How can I protect my home? That is
why we thought it important to discuss
this asset and how to protect it from
outside threats.
This article will look at the pros and
cons of state homestead laws, tenancy
by the entirety (TBE), limited liability
companies (LLCs), family limited partnerships (FLPs), and the debt shield.
You may be surprised to find out that a
situation you have always feared could
actually be your ally in your quest to
protect your most valuable asset. This
will be another example of a secret of
the affluent that completely contradicts conventional ideas held by many
average Americans.
STATE HOMESTEAD LAW

Ever y U.S. state has some t y pe of

homestead protection law. In most
states, such as New Jersey, New York
and California, the level of protection
is very low when compared with what
real estate is worth (New Jersey: $0,
New York: $100,000, California: $50
to $100,000). On average, state homestead law protection ranges between
about $30,000 and $50,000 of equity
much less than the typical home
value of the affluent.
TENANCY BY THE ENTIRETY

Tenancy by the entirety (TBE), a form

of joi nt ow nersh ip ava i lable i n a
number of states, is a decent option for
clients of those states, such as Alaska,
Arkansas, Delaware, Florida, Hawaii,

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Illinois, Indiana, Kentucky, Maryland,

Massachusetts, Michigan, Mississippi,
Missouri, New Jersey, New York, North
Carolina, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee,
Vermont, Virginia, Wyoming, and the
District of Columbia. In these states,
the TBE homestead protection falls
between +1 and +3, depending on the
state and its court interpretations.
Inherent in TBE are a number of risks,
including the following:
Joint risk. Tenancy by the entirety
provides no shield whatsoever against
joint risks. Those are lawsuits that arise
from your jointly owned real estate and
even, potentially, car accidents.
Divorce risk. If you rely on TBE for
protection and you get divorced before
or during the lawsuit, you lose all
protections from TBE.
Liability risk. If you rely on TBE for
protection and one spouse dies before
or during the lawsuit, you lose all
protections from TBE.
Death risk. Tenancy by the entirety is
a poor ownership form for estate-planning purposes because, at the death of
the first spouse, the entire value of the
home will automatically be entered into
the surviving spouses taxable estate.
For t h e s e r e a s on s , w e do not
generally recommend TBE alone as
a protective tool. The savvy affluent
generally combine TBE with the debt
shield technique.
LLCS AND FLPS

Limited liability companies and limited

family partnerships are two tools that
can protect a primary residence. In
fact, many advisers regularly recommend these techniques to their clients
for this very purpose. The drawbacks
of these methods are perfect examples
of why multidisciplinary planning is

necessary for the affluent. Lets look at

some of the problems with conducting
asset-protection planning in a vacuum
with respect to the home.
Drawbacks of LLCs and FLPs for
protection of home: Owning real estate
in an FLP or LLC can be attractive.
However, when it comes to the primary
residence, these entities are not very
common or sensible choices of the
savvy affluent.
Unlike other assets, the family home
has unique ta x attributes most
notably, the deductibility of mortgage
interest and the $250,000 per-person
($500,000 per couple) capital-gains tax
exemption. By owning the home within
an LLC or a FLP, both of these tax benefits may be lost, unless only one spouse
owns 100 percent of the interests in the
LLC or FLP. In a recent case, however,
the court set aside the protections of an
LLC when only the debtor owned 100
percent of the interests in the LLC. For
these reasons, we no longer recommend
single-owner LLCs and FLPs to protect
the family home.
Qualified personal residence trusts:
When using a qualified personal residence trust (QPRT), the owner transfers
ownership of the home to the QPRT
irrevocably. While this is certainly
effective for both asset-protection and
estate-planning purposes, it comes with
a significant cost: You no longer own
your home. In fact, when the term of
years is up (typically 10 years), you have
to pay fair-market value rent to the trust
in order to live in the home.
Homes with mortgages on them
present further tax difficulties, as well.
For these reasons, while the QPRT is a
strong asset-protection tool, we typically do not advise using it for most
younger clients whose main concern
is asset protection as opposed to estate
planning. Nonetheless, if it can be
implemented correctly, a QPRT receives
a rating of +4 or +5 protection.
The unlikely solution most advisers
cant even mention: Oddly enough, the
HOME PROTECTION see page 75

ES467486_DT0814_072.pgs 07.21.2014 20:21

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End with

relief.

1, 2

Topicort (desoximetasone) is indicated

for the relief of the inflammatory
and pruritic manifestations of
corticosteroid-responsive dermatoses.
Important Safety Information
Topicort (desoximetasone) is contraindicated
in those patients with a history of hypersensitivity
to any of the components of the preparation.
The following local adverse reactions are reported
infrequently with topical corticosteroids, but may occur
more frequently with the use of occlusive dressings.
These reactions are listed in an approximate decreasing
order of occurrence: Burning, itching, irritation, dryness,
folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation,
perioral dermatitis, allergic contact dermatitis, maceration of the
skin, secondary infection, skin atrophy, striae, and miliaria. Because
of the potential for systemic absorption, use of topical corticosteroids may
require that patients be periodically evaluated for HPA axis suppression.
Pediatric patients may demonstrate greater susceptibility to topical
corticosteroid-induced HPA axis suppression and Cushings syndrome than
mature patients because of a larger skin surface area to body weight ratio.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushings syndrome, and
intracranial hypertension have been reported in pediatric patients receiving topical
corticosteroids. Administration of topical corticosteroids to pediatric patients should
be limited to the least amount compatible with an effective therapeutic regimen.
Chronic corticosteroid therapy may interfere with the growth and development of
pediatric patients.
References: 1. Topicort Cream 0.05% Prescribing Information.
Taro Pharmaceuticals U.S.A., Inc. 2. Topicort Ointment 0.05%
Prescribing Information. Taro Pharmaceuticals U.S.A., Inc.

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See brief summary of Prescribing Information on reverse side.

2014 Taro Pharmaceuticals U.S.A., Inc.
TaroPharma and Topicort are registered trademarks of Taro Pharmaceuticals U.S.A., Inc.

AD100-0037

April 2014

ES442014_DT0614_TOPICORT1_FP.pgs 05.21.2014 01:04

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Topicort (Desoximetasone Cream USP) 0.05%

Topicort (Desoximetasone Ointment USP) 0.05%

Rx only
Rx only

As with other corticosteroids, therapy should be discontinued when control is

achieved. If no improvement is seen within 4 weeks, contact the physician.

Brief Summary of Prescribing Information. For complete prescribing information

consult ofcial package insert.

Laboratory Tests
The following tests may be helpful in evaluating the hypothalamic-pituitaryadrenal (HPA) axis suppression:
Urinary free cortisol test
ACTH stimulation test

For topical use only. Not for oral, ophthalmic, or intravaginal use.
INDICATIONS AND USAGE
Topicort (desoximetasone cream USP) 0.05% and Topicort (desoximetasone
ointment USP) 0.05% are indicated for the relief of the inammatory and pruritic
manifestations of corticosteroid-responsive dermatoses.
CONTRAINDICATIONS
Topical corticosteroids are contraindicated in those patients with a history of
hypersensitivity to any of the components of the preparation.
WARNINGS
Keep out of reach of children.
PRECAUTIONS
General
Systemic absorption of topical corticosteroids can produce reversible
hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for
clinical glucocorticosteroid insufciency. This may occur during treatment or
upon withdrawal of the topical corticosteroid.
Because of the potential for systemic absorption, use of topical corticosteroids
may require that patients be periodically evaluated for HPA axis suppression.
Factors that predispose a patient using a topical corticosteroid to HPA axis
suppression include the use of more potent steroids, use over large surface
areas, use over prolonged periods, use under occlusion, use on an altered skin
barrier, and use in patients with liver failure.
An ACTH stimulation test may be helpful in evaluating patients for HPA axis
suppression. If HPA axis suppression is documented, an attempt should be
made to gradually withdraw the drug, to reduce the frequency of application, or
to substitute a less potent steroid. Manifestations of adrenal insufciency may
require supplemental systemic corticosteroids. Recovery of HPA axis function is
generally prompt and complete upon discontinuation of topical corticosteroids.
Cushings syndrome, hyperglycemia, and unmasking of latent diabetes mellitus
can also result from systemic absorption of topical corticosteroids.
Use of more than one corticosteroid-containing product at the same time may
increase the total systemic corticosteroid exposure.
Pediatric patients may be more susceptible to systemic toxicity from use of
topical corticosteroids.
Local Adverse Reactions with Topical Corticosteroids
Local adverse reactions may be more likely to occur with occlusive use, prolonged
use or use of higher potency corticosteroids. Reactions may include atrophy, striae,
telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions,
hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary
infection, and miliaria. Some local adverse reactions may be irreversible.
Allergic Contact Dermatitis with Topical Corticosteroids
Allergic contact dermatitis to any component of topical corticosteroids is usually
diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis
of allergic contact dermatitis can be conrmed by patch testing.
Concomitant Skin Infections
Concomitant skin infections should be treated with an appropriate antimicrobial
agent. If the infection persists, Topicort (desoximetasone cream USP) 0.05% or
Topicort (desoximetasone ointment USP) 0.05% should be discontinued until the
infection has been adequately treated.
Information for the Patient
Patients using topical corticosteroids should receive the following information
and instructions:
1. This medication is to be used as directed by the physician. It is for external
use only. Avoid contact with the eyes.
2. Patients should be advised not to use this medication for any disorder other
than for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or 4.
wrapped as to be occlusive unless directed by the physician.
4. Patients should report any signs of local adverse reactions, especially under
occlusive dressings.
5. Other corticosteroid-containing products should not be used with Topicort
(desoximetasone cream USP) 0.05% or Topicort (desoximetasone ointment
USP) 0.05% without rst consulting with the physician.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic
potential or the effect on fertility of topical corticosteroids.
Desoximetasone was nonmutagenic in the Ames test.
Pregnancy. Teratogenic Effects. Pregnancy Category C
Corticosteroids have been shown to be teratogenic in laboratory animals when
administered systemically at relatively low dosage levels. Some corticosteroids
have been shown to be teratogenic after dermal application in laboratory animals.
Desoximetasone has been shown to be teratogenic and embryotoxic in mice,
rats, and rabbits when given by subcutaneous or dermal routes of administration
in doses 15 to 150 times the human dose of Topicort (desoximetasone cream
USP) 0.05%, or Topicort (desoximetasone ointment USP) 0.05%.
There are no adequate and well-controlled studies in pregnant women on
teratogenic effects from topically applied corticosteroids. Therefore, Topicort
(desoximetasone cream USP) 0.05% or Topicort (desoximetasone ointment
USP) 0.05% should be used during pregnancy only if the potential benet justies
the potential risk to the fetus. Drugs of this class should not be used extensively
on pregnant patients, in large amounts, or for prolonged periods of time.
Nursing Mothers
It is not known whether topical administration of corticosteroids could result in
sufcient systemic absorption to produce detectable quantities in breast milk.
Systemically administered corticosteroids are secreted into breast milk in quantities
not likely to have a deleterious effect on the infant. Nevertheless, caution should
be exercised when topical corticosteroids are administered to a nursing woman.
Pediatric Use
Pediatric patients may demonstrate greater susceptibility to topical
corticosteroid-induced HPA axis suppression and Cushings syndrome than
mature patients because of a larger skin surface area to body weight ratio.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushings syndrome,
and intracranial hypertension have been reported in pediatric patients receiving
topical corticosteroids. Manifestations of adrenal suppression in pediatric
patients include linear growth retardation, delayed weight gain, low plasma
cortisol levels, and absence of response to ACTH stimulation. Manifestations of
intracranial hypertension include bulging fontanelles, headaches, and bilateral
papilledema.
Administration of topical corticosteroids to pediatric patients should be limited
to the least amount compatible with an effective therapeutic regimen. Chronic
corticosteroid therapy may interfere with the growth and development of
pediatric patients.
ADVERSE REACTIONS
The following local adverse reactions are reported infrequently with topical
corticosteroids, but may occur more frequently with the use of occlusive
dressings. These reactions are listed in an approximate decreasing order of
occurrence:
Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions,
hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of
the skin, secondary infection, skin atrophy, striae, and miliaria.
In controlled clinical studies the incidence of adverse reactions were low (0.8%) for
Topicort (desoximetasone cream USP) 0.05% and included pruritus, erythema,
vesiculation, and burning sensation. The incidence of adverse reactions was low
(0.2%) for Topicort (desoximetasone ointment USP) 0.05% and included mild
burning sensation at the site of application.
OVERDOSAGE
Topically applied corticosteroids can be absorbed in sufcient amounts to
produce systemic effects (see PRECAUTIONS).
Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
Dist. by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne,
NY 10532
Topicort and TaroPharma are registered trademarks of Taro Pharmaceuticals
U.S.A., Inc. and/or its afliates.
You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit www.fda.gov/Safety/MedWatch/default.htm, or call 1-800-FDA-1088.

Issued: April 2014

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BUSINESS OF DERMATOLOGY

AUGUST 2014 DERMATOLOGYTIMES.COM

75

HOME PROTECTION:
How to guard your most valuable asset from outside threats from page 72
best way to protect a home is probably
the same way we all started owning our
homes with someone elses money.
By not having any, or very little, equity
in your home, the bank owns the home.
A creditor has very little to gain from
trying to attack the home when there
is little to no equity especially when
that small amount of equity is partially
or completely protected through homestead exemptions in many states.
Because we cant go back in time
and stop paying down our mortgages,
we have to find a way to address this
issue in the present. Unfortunately,
most advisers cant even tell you how
to do this. Affluent Americans have to
decipher financial information that is
directed toward average Americans.
C on s ide r t h i s e x a m ple : I nd ividuals and firms in the securities
and insurance industries have been
the subject of a number of a rising
number of complaints and lawsuits
over the past 15 years. As a result, the
regulatory agencies and compliance
depa r t ments of t hese compa nies
have forbidden their representatives
from recommending that their clients
remove equity from real estate and
invest it into either securities or insurance products. These advisers cannot
even accept loan proceeds from a
refinanced property. These companies adopted t his polic y because
t he y fea red t hat less f i na nc ia l ly
sophisticated homeowners wouldnt
understand the risk of this maneuver
and might lose their homes if the
investments they made with the loan
proceeds didnt perform well.
We approve of protec t i ng less
sophisticated investors and of protection against unscrupulous salespeople
(and there are many of both). However,
to threaten to terminate advisers who
want to help aff luent clients whose
asset-protection concerns outweigh
the investment risks that they and their
teams understand is ridiculous. In this
situation, the affluent cant even get the
advice they require. Lets discuss that
technique that most advisers cant share
but the savvy affluent know and implement on a regular basis: the debt shield.

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THE DEBT SHIELD

The debt shield can be the most effective way to shield the equity of the home.
Essentially, using a debt shield means
getting a loan against most of the equity
in your home. For many clients, this
is counterintuitive; they want to pay
down the mortgage as much as possible.
While this may have an emotional
appeal, for asset-protection purposes,
it is simply bad strategy.
For example, to help people protect
the equity in their home, one financial
institution we examined for a client
designed an interesting debt-shield
program. The bank loaned the client
funds equal to up to 90 percent of the
value of the home and then filed a mortgage first, second or even third in
order to consume any remaining equity.
The home was then protected.
The loan funds were placed in an
asset-protected trust, one drafted
for the client by an asset-protection
attorney. Those funds were owned by
the trust and, under the loan documents, were required to be placed in
the banks certificate of deposit (CD)
account. Further, the bank contractually guaranteed that its loan rate would
be only 1 percent greater than its CD
rate, meaning that this structure cost
participants just 1 percent of the home
equity to implement (plus legal fees).
When the client retires or feels that the
threat to the home has diminished, the
CD account pays off the loan and the
mortgage is released.
THE ENHANCED DEBT SHIELD

In the basic debt shield scheme outlined

above, there is a real cost to the loan
versus the investment a shortfall of
1 percent per year. What if the funds
you gain by shielding your home could
be invested in a way that provided an
opportunity to earn more within the
investment than the loan interest would
cost? In this way, you would make
money by shielding the home through
the concept of leverage. This is easily
achievable in many states.
In some states, certain investment
classes are asset-protected under state
law. The most common such assets are

annuities and cash-value life insurance

policies, which are protected in many
states such as New York, Florida, Texas
and Ohio, among many others. In states
such as these, you may take a loan for
6 to 8 percent (partially or totally taxdeductible) and be able to invest in an
annuity or insurance policy that credits
5 to 8 percent or more (tax-deferred).
When you consider that the mortgage
interest may be tax deductible, the true
after-tax cost to you may be as little as
3.5 to 5 percent.
If your asset-protected investment
returns approximately 6 percent (many
life insurance policies have guaranteed
minimum crediting rates of 3 or 4 percent)
and you are paying only 4 or 5 percent
(after taxes) in interest, you can actually
make money while protecting your home.
Of course, this gain is not guaranteed and
you could lose money in this arrangement. The savvy affluent understand
these risks and act appropriately.
CONSIDER THIS

For most affluent clients, there is no

more financially valuable and psychologically and emotionally important
asset than the family home. Some states
offer great homestead protection, but
most states offer inadequate protection. If you do not enjoy unlimited
homestead protection, you must make
it a priority to work with your team to
protect your home. If you dont protect
this property, there is no need to bother
protecting any other assets. The only
thing more valuable than your home is
your future income.
Michael S. Berry, Ch.F.C., is a financial planner in
Newtown, Connecticut. He was named one of the 150
Best Financial Advisors for Physicians in 2013 by
Medical Economics. You can reach him at 855-3258674 or MBerry@daktori.com. He is a co-author with
Mr. Jarvis of The Physicians Money Manual.
Christopher R. Jarvis, M.B.A., C.F.P., president and
co-founder of Daktori, has more than 20 years of
financial consulting experience and has written 12
books including Wealth Secrets of the Affluent and
The Physicians Money Manual. He too was recognized as one of the 150 Best Financial Advisors for
Physicians in 2013 by Medical Economics. You can
reach him at 855-325-8674 or jarvis@daktori.com.

ES467488_DT0814_075.pgs 07.21.2014 20:21

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76

BUSINESS

OF DERMATOLOGY
DERMATOLOGY

AUGUST 2014
2013 DERMATOLOGYTIMES.COM

PRESSURE MOUNTING:
Dermatologists must be proactive in documenting value of their services from page 66
If we put our heads in the sand,
however, theres a huge risk to the
specialty of being marginalized, he says.

Number of Accountable Care Organizations Over Time By Sponsoring Entity

428

ACO ADJUSTMENTS
208

330

156

146

156
113

108

5
1/31/2013

5
12/31/2012

32

9/30/2012

31

6/30/2012

27
5

3/31/2012

22
2

12/31/2011

19
1

9/30/2011

15
1

71

6/30/2011

30
12
1

45

3/31/2011

22
10
0

44

12/31/2010

16
7
0

91

9/30/2010

31
19
8
3
0

86

142

6/30/2010

22
15
5
2
0

59

65

138

167

3/31/2010

10
5
3
2
0

46
27
14
5
0

91

71
48

160

202
189

Q1
2010

Q2
2010

Q3
2010

Q4
2010

Q1
2011

Q2
2011

Q3
2011

Q4
2011

Q1
2012

Q2
2012

Q3
2012

Q4
2012

Jan
2013

Total

Physician Group

Hospital System

Insurer

Community-Based Organization

Source: Health Affairs blog, Feb. 19, 2013, by David Muhlestein

A few all-products clauses allow

insurers to sign physicians up for any
future insurance plans at lower rates,
Dr. Resneck says. In other cases, he says,
an insurer may require a non-exchange
physician with whom the company has
an existing contract to see exchange
patients but at the higher rate established by the existing contract.
You must watch carefully, though,
and make sure theyre actually paying
you that rate, he says.
To date, Dr. Resneck says that to keep
premiums low, insurers are beginning to
staff their exchange plans with doctors
who have lower paying contracts and
whom the insurers judge to use fewer
resources on each patient. This often
happens without regard to the sickness
of each doctors patients or the quality
of care provided, which insurers arent
yet able to reliably account for, he says.
Experts expected such narrow networks
in the exchange plans. But some insurers
have already begun to take that same
approach with Medicare Advantage
(MA) plans as well.
In the last several months, weve
seen some insurers start sending letters
to selected dermatologists in their MA
plans, often the Mohs surgeons, firing

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these physicians for being high-cost

providers, Dr. Resneck says.
And we know that theyre doing that
based not on any sort of value measure
that compares your costs versus the
quality of care you provide insurers
tell us they cant do that right now. Its
usually purely based on cost, he says.
MEASURES OF VALUE

Insurers are asking specialty societies

to help provide better measures of
value that take quality and patient mix
into account.
The risk of our not providing this in
a way we design ourselves is that other
people are going to collect the data, Dr.
Resneck says. Presently, other people are
filling in the blanks using claims data,
which cannot assess the value a physician adds versus his or her costs.
Insurers want us to identify how we
want to be judged and measured. And
wed rather do it, than have them do it.
We are going to have to provide data to
prove that the things we do add value,
individually and as a specialty.
Dr. Resneck says he is confident that
dermatologists are perspicacious and
proactive enough to figure out how to
thrive in this changing environment.

Regarding ACOs, says Marta VanBeek,

M.D., M.P.H., The bad news is that
theyre not going away. The good news
is that ACOs are a major improvement
over health maintenance organizations
(HMOs), and theyre not necessarily bad
for dermatology. She is Mohs fellowship
director and clinical associate professor
of dermatolog y, University of Iowa
Carver College of Medicine, Iowa City.
An ACO is a combination of many
medical providers under a virtual financial umbrella, usually using the same
electronic medical record, Dr. VanBeek
says. In a Medicare ACO providers are
paid on a fee-for-service basis throughout
the year. At years end the ACO calculates
whether total payments exceeded or fell
short of the Medicare benchmark and
whether a practice met quality metrics.
Within this framework, she says, ACO
patients can go directly to dermatologists unaffiliated with the ACO, or ACOs
can refer their patients to dermatologists.
Given the pressure on primary care
practices running ACOs to reduce costs,
If youre a dermatologist who provides
timely, efficient and high-quality care for
a lower cost, you will get many referrals
from the ACO, she says.
ACOs want dermatologists because
we typically have very high patient
satisfaction levels. Presumably, we also
can provide much more cost-efficient
care, in a shorter amount of time, than
primary care physicians because we are
trained to be quicker diagnosticians of
skin problems, Dr. VanBeek adds.
Nevertheless, The problem with
ACOs is that every year, the benchmark
is lowered, by either the private payer or
Medicare. Theres only so much juice
you can squeeze out of the lemon before
care rationing begins. We need to be
standing up for our patients to make sure
that doesnt happen.
COST DRIVERS

Over the past 12 years, the average

annual premium to cover a family of
four has risen from $6,000 to $16,000,
Dr. VanBeek says. Many stakeholders,
Republican and Democrat, believe that
the fee-for-service system is driving

ES474090_DT0814_076.pgs 07.29.2014 04:30

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AUGUST 2014 DERMATOLOGYTIMES.COM

these costs, she says. In fee-for-service,

Everybodys in their own silo. Hospitals, primary care physicians, specialists
and labs all get paid separately.
As such, fee-for-service opponents
say that this model focuses on prices
paid by individuals, not overall costs.
If a dermatologist freezes a Medicare
patients 15 actinic keratoses (AKs) in
the office, Dr. VanBeek says, The price
to that Medicare patient is often zero.
But the cost of that treatment to society is
much larger. If you would treat those 15
AKs with a generic topical product, the
price to the patient rises dramatically,
but the cost to society is much lower.
Either way, she says, the cost of
medical care is attributed to someone
(an individual patient) or something
(society via Medicare or a private payer).
Phy sic ia ns a re used to bei ng
concerned with the cost to the patient.
Now we need to be cognizant of the
entire societal cost, Dr. VanBeek says.
The notion of replacing fee-forservice, however, is distressing for all
of medicine, she says. For decades,
we have thought about medical care in
distinct units of utilizations, visits, biopsies and surgeries. Suddenly, were being
asked to look at what we spend on entire
populations. This is a paradigm shift in
the way we deliver and think about care.
You cannot phase out fee-for-service
with an alternative payment model if
you dont also require quality measures, she says.
The healthcare rationing and poor
outcomes of the HMO model stemmed
f rom just such a n oversig ht, Dr.
VanBeek says.
But the quality requirements written
into the ACA mean that not only do
you have to save money, but you have
to prove that your patients do well by
meeting the metrics, she says.

BUSINESS OF DERMATOLOGY

Nobody knows, Dr. VanBeek says. It is

likely ACO managers will prioritize healthcare infrastructure, hospitals/pharmacies
and primary care providers, and unlikely
that dermatologists will get a taste.
Probably, You will be paid by fee-forservice throughout the duration of your
participation, she says. ACOs main
effect on dermatology practices will
come through referral patterns, whether
theyre in an ACO or not.

Although there are still unknowns

about the ultimate impact of ACOs, Dr.
VanBeek is confident that dermatologists
can thrive under the new paradigm.
If we remain engaged and informed,
we can better preserve the patientphysician relationship and protect the
specialty we all love, she says. DT
Disclosures: Drs. Resneck and VanBeek report no
relevant financial interests.

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This ofer not valid with any other
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DIVIDING THE SAVINGS

Another concern regarding ACOs is

how they will divide savings. For 2012,
Dr. VanBeek says, physician-led ACOs
the most common type saved
the most. But among 114 Medicare
shared savings programs, she says,
only 29 saved enough money to share
with providers or participating institutions. Versus non-ACO beneficiaries,
Pioneer ACOs demonstrated much
smaller growth in healthcare spending
13 of 32 achieved savings of $87.6
million in 2012, she says.
How will ACOs share or distribute
savings?

See www.mti.net/derm for full details.

Call (800) 924-4655

Email sales@mti.net
Visit us online at
www.mti.net/derm

3655 W Ninigret Drive, Salt Lake City, Utah 84104-6572 USA


t

t
'BY



www.mti.net

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77

Strength in patient care.

ES474089_DT0814_077.pgs 07.29.2014 04:30

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78

BUSINESS

OF DERMATOLOGY

AUGUST 2014 DERMATOLOGYTIMES.COM

Health information exchanges

introduce patient consent questions
Ken Terry | Staff Correspondent

patient privacy issues may come into

play. Physicians need to be aware of
state and federal legal requirements
and should follow best practices to
ensure pat ient privac y and avoid
liability. This includes understanding
t he role of pat ient consent in t he
exchange process.
In general, the federal Health Insurance Portability and Accountability
Act (HIPA A) r u les a l low t reat i ng
providers to exchange information
about patients they have in common,
regardless of whether they are part of
the same organization. Patients are
already asked to sign HIPAA privacy
notices and consent forms that allow
their information to be disclosed to
designated individuals. Depending
on the state, patients may also have
to give specific consent for information to be exchanged through HIEs
that transfer electronic data between

As physicians, hospitals and health

systems increasingly share patient
data between providers and across
healthcare organizations, the issue
of patient consent becomes critical.
Should patients be required to opt in or
opt out of health information exchanges
(HIEs)? And what are physicians legal
obligations in making sure this data is
exchanged securely and accurately?
Although meaningful use stage 2 has
been effectively delayed, physicians
who wish to attest to it this year or next
will have to exchange patient information electronically at transitions of care,
including referrals. Physicians might
also be asked to send records online to
other doctors when patients self-refer
to them.
Depending on how this information
is exchanged and what is exchanged,

OPT-IN OR OPT-OUT?
Patient consent rules in the United States
NH

WA
MT
OR

ND

ID
WY
NV

VT

CA
AZ

MA
WI

SD

CO

NY

MI

IA

NE
UT

ME

MN

IL

KS

MO
OK

NM

OH

IN

WV

VA
NC
SC

KY
TN

AR
MS AL

TX

PA

GA

RI
CT
NJ
DE

MD
DC

LA
FL

AK

HI
Opt in

Opt out

Other*

* Other indicates the state has both opt-in and opt-out rules, a hybrid system, pending rules, or
no rules identifed yet.
Source: 2013 self-reported data by HIE grantees to the Offce of the National Coordinator for Health Information Technology

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participating providers or provide

access to it online.
Nearly half of the states have or plan
to have these opt in requirements for
health information exchange in their
statewide HIEs, according to the Office
of the National Coordinator of Health
IT (ONC). Most of the other states have
opt out policies that allow patients to
choose not to have their information
exchanged online.
The different ways states treat electronic data exchange could have implications for the viability of HIEs and for
physicians ability to access information
on their patients from other providers.
Opt in makes it hard to operationalize the full benefits of HIEs, says
David Harlow, a healthcare attorney
based in Newton, Massachusetts and
author of the HealthBlawg blog. With
an opt-in requirement, a lot of people
dont bother to opt in.
That is not necessarily the case,
however, if people are educated about
t heir choices. The Massachusetts
eHealth Collaborative (MAeHC), for
example, built HIEs in three communities and incorporated an opt-in policy.
Front-desk staff in doctors offices gave
patients brochures about the HIEs and
asked them to sign consent forms. More
than 90 percent did, Micky Tripathi,
chief executive officer of MAeHC, told
iHealthBeat.
A not her i s s ue i s how c on s ent
requirements in different states affect
the ability to exchange records across
state lines. Northern snowbirds
who winter in the South, for example,
may need to have health information
exchanged between their home states
and the states where they reside in the
winter. If some states allow information exchange unless patients opt out
and others require them to opt in, that
hamstrings the provider in the other
state, Mr. Harlow says.
That only begins to describe the
impact of variations in state laws. For
example, Indiana privacy laws are no
more restrictive than HIPAA, notes Eric
Thieme, chief administrative officer

ES472793_DT0814_078.pgs 07.26.2014 04:02

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AUGUST 2014 DERMATOLOGYTIMES.COM

and general counsel for the Indiana

Health Information Exchange (IHIE),
one of the nations largest and oldest
HIEs. IHIE has an opt out policy to that
health system participants adhere to,
he says.
In California and New York, however,
providers cant agree on what the state
privacy laws mean in regard to HIEs,
Mr. Thieme says. A New York law says a
patient doesnt have to give consent for
data to go to an HIE, but must consent
for anyone to view the data in the HIE.
That muddies the waters, he notes.
To date, the federal government has
not tried to impose a national standard
in this area. An Office of the National
Coordinator for Health IT security and
privacy framework for state health
information exchanges advocates
what it calls meaningful consent
i.e., consent that follows substantial
patient education but does not take
a position on opt-in versus opt-out.
Physicians may wonder how to
remember which patients opted in
or out when they transmit data to an
HIE. An electronic health record (EHR)
check box may show the information,
but that doesnt necessarily prevent
practices from making that patients
data available to an HIE along with all
of their other patient records.
The Indiana exchange has developed a simple solution: Its members
send EHR data on all of their patients,
along with a list of those who have
opted out. IHIE uses a software mechanism to block other HIE participants
from viewing information on those
patients, Mr. Thieme says.
THE SENSITIVE DATA QUAGMIRE

Federal and state laws require that

certain kinds of data be segregated
before records a re excha nged
between providers. This includes
psychotherapy notes and alcohol and
substance abuse treatment records.
I H I E proh ibit s pa r t ic ipat i ng
providers from sending records of
either type. Beth Israel Deaconess
Medical Center (BIDMC), a Bostonarea healthcare system, locks up
and wont make patients mental
health records available even to other
providers in its own system without
patient consent, BIDMC chief informa-

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BUSINESS OF DERMATOLOGY

tion officer John Halamka told InformationWeek Healthcare.

While laws and policies in this area
are fairly straightforward, the picture
becomes murkier where other types
of sensitive data are concerned. For

79

example, patients may not want other

treating providers to see that they
have been diagnosed w ith HI V or
another sexually transmitted disease.
Mr. Thieme says those are the most
PATIENT CONSENT see page 80

After 50 years of supporting the development of dermatology . . .

OUR EYES REMAIN

...................................................................

ON THE FUTURE
Since the DF was established in 1964, dermatology has emerged
as a vibrant and vital specialty in the house of medicine.
For fve decades, the Foundation has provided funding that
has helped to develop and retain new generations of teachers,
researchers and mentors, enabling advancements in patient care.
Individual physician support has always been at the core of the
DFs ability to support progress. In an era of fat NIH funding,
and ever-changing economic, social and health care trends,
dermatologists participation is more crucial than ever.

With help from the dermatologic community,

we can remain focused on furthering
every aspect of the specialty.
Celebrate the past and ensure the future.
Please visit the DF Contribution Center at
dermatologyfoundation.org and make a contribution.

...................................................................

Underwritten by an educational grant from Galderma Laboratories, L.P.

ES472794_DT0814_079.pgs 07.26.2014 04:02

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80

BUSINESS

OF DERMATOLOGY
DERMATOLOGY

AUGUST 2014
2013 DERMATOLOGYTIMES.COM

PATIENT CONSENT:
Be aware of state, federal legal requirements for secure exchange of data from page 79
frequently requested exclusions in
Indiana, but some patients may not
want to disclose information on other
health conditions either.
Even if providers want to accommodate these patient requests, todays
EHRs make it difficult for healthcare
organizations to do so. Experts say that
EHRs have difficulty segregating sensitive information, partly because much
of the data is embedded in free text,
rather than structured fields that can
be manipulated.
Beyond these categories, providers
are not legally required to withhold
certain data in patient records when
they exchange them with other treating
providers.
Under HIPAA, the patient has the
right to segregate some things only
if the provider is willing to do it, Mr.
Harlow says. Most providers are not
willing to customize anything, because
they dont have the tools to do it easily
and reliably. So theyre just going to say
no, except for some things that must be
segregated and not go to a payer if the
patient so desires.
Partly because of the difficulty of
sequestering specific information,
Mary Griskewicz, senior director of
health information systems for the
Healt h Informat ion Management
Systems Societ y, says its simpler
from a legal standpoint to ask the
patient to allow having all of his or
her records exchanged.
From a risk assessment perspective,
thats the way to go, she says. A lot of
providers say, basically, that if you want
to get treated, you have to agree.
LIABILITY ISSUES

In general, healthcare organizations are

not liable for security or privacy breaches
at other organizations with which theyve
exchanged patient data, Mr. Harlow says.
If the handing off of the data can
be documented to have taken place in
an appropriate manner, the next entity
would have primary liability for any
such release, Ms. Griskewicz says.
Under the HIPA A Omnibus rule
released last year, the sending provider
could potentially be held liable for a

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5 QUESTIONS TO ASK AN HIE

What state regulations do you

have to comply with?

How do you make sure that only

patients who have opted in (or
in an opt-out state, those who
have not opted out) can have
their records viewed by other
providers?

Can you segregate certain kinds

of data when that is requested
by a provider on behalf of one of
their patients?

Will you provide an audit trail

for an individual patient if their
provider requests it?

Are you willing to sign a

business associate agreement
that specifes your security
duties under HIPAA?

breach unless the provider vetted the

security systems and policies of the
receiving provider, but thats only a legal
theory at this point.
Whats not theoretical is that the
HIPAA rule treats business associates
of providers as subcontractors who
share liability for security breaches of
patient data. So healthcare providers
have dema nded t hat t hese nonHIPAA-covered entities sign business
associate agreements (BA As) that
specify their responsibilities.
Mr. Harlow doesnt think that HIEs
must have such agreements if all they
do is act as pipes to transmit data
from one provider to another. But if
they touch the data in any way as
many HIEs do when they help providers
analyze data they must have a BAA,
he says. IHIE has BAAs with all of its
customers and vendors who handle
its personal health information, Mr.
Thieme notes.
Ac c ord i n g to M r. Ha rlow, t he
HIPAA rule has yet to be finalized in
the area of providing patients access
to audit trail data show ing who
viewed their data and when. IHIE
will provide this data to organizations that request it for patients. So
far the exchange has received few
such requests, Mr. Thieme says.
COMMON SENSE PATIENT CONSENT

U lt i m at e l y, he a lt h i n f or m at ion
exchange is about enabling physi-

cians to see the information they need

to provide the best possible care to
their patients, Ms. Griskewicz says. In
certain situations, the physician must
make critical decisions about whether
to obtain that data or supply data that
a colleague needs to treat the patient.
If you enter into a relationship with a
provider, you do that because you want
their first duty to be to treat you, she
says. If the doctor is treating a person
that has a condition and cant represent
themselves, the doctor will do what they
have to do.
There has to be a level of faith
and trust. If you have a particular
condition that you dont want shared,
providers are going to look at their
policies and procedures and see what
they can accommodate.
Patient consent issues in health
information exchange have not yet been
fully worked out, and physicians should
be aware of that, even as they try their
best to comply with laws and policies.
As the electronic interchange spreads,
public awareness will increase, and the
differences between opt-in and opt-out
may get messy, Mr. Harlow says.
But over time, he adds, consumers
will appreciate the improvements in
healthcare that will result from the
increased flow of information.
In the long run, it will be a good
thing, and it could reduce the duplication of diagnostics and get the right
care to patients sooner. DT

ES472792_DT0814_080.pgs 07.26.2014 04:02

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A 1-hour Webinar with Live Q&A | Wednesday, September 10th, 7 p.m. EDT

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ALSO AVAILABLE ON DEMAND AFTER BROADCAST

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Join us for an educational webinar featuring Dr. Zoe Draelos, Dermatology Times
editorial advisory board member and renowned clinical and research dermatologist,
who will be discussing important new data from Phase IV clinical studies of
Kenalog Spray (Triamcinolone Acetonide Topical Aerosol, USP) 0.147 mg/g
and Halog (Halcinonide, USP) 0.1% Cream

HALOG is a registered trademark of Ranbaxy Laboratories Inc.

Kenalog is a licensed trademark of Bristol-Myers Squibb Company.
Funding and content provided by Ranbaxy Laboratories Inc.

PRESENTED AS A PROMOTIONAL WEBINAR TO

Clinical Analysis for Todays Skincare Specialists

SCAN THE QR CODE TO REGISTER. OR VISIT:

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ES473640_DT0814_081_FP.pgs 07.29.2014 00:47

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AUGUST 2014 DERMATOLOGYTIMES.COM

Medicated skincare bars

treat variety of conditions
A SET OF SKINCARE BARS available only through physician offices are
formulated to treat a variety skin conditions, such as acne, dandruff and
psoriasis.
The five medicated products include a 10 percent benzoyl peroxide bar,
a 2 percent zinc pyrithione bar, a 2 percent salicylic acid bar, a 1 percent
tolnaftate/9 percent sulfur bar and a 0.5 percent coal tar bar. Physicians who
dispense the bars in their practices can guide patients on their appropriate
use for maintenance and prevention, according to the company, especially if
the products are used as adjunct therapy with other medications.
All of the bars contain vitamins A and E, coconut oil and shea butter. They
are aesthetically pleasing and deliver a good lather, the company states.
ERMIS LABS
www.ermislabs.com

THREE-IN-ONE TREATMENT
TACKLES ACNE, BLEMISHES
FIRST CRUSH SKIN
CARE has launched
a multitasking
product for acne and
other blemish breakouts.
The 3-in-1 Acne/
Blemish Treatment
includes a cleanser
to eliminate dirt and
oil; a treatment to get
rid of dead skin cells
and blemish-causing
bacteria; and a toner
to freshen, firm and
invigorate the skin,
according to the company.
The treatment is appropriate for
all skin types and does not contain
benzoyl peroxide. The formulation
includes grape seed extract, salicylic acid, tea tree oil, lavender oil
and ginseng extract.
The products can be ordered
individually in 6-ounce tubes, or as
part of a four-piece display set.
FIRST CRUSH SKIN CARE
www.firstcrushskincare.com

TWO-PHASE BODY
CREAM FIGHTS CELLULITE

select either the 255 g dispenser or

the 90 g tube of EpiCeram.
EpiCeram Controlled Release
Skin Barrier Emulsion is the only
topical agent formulated with three
essential lipids ceramides, free
fatty acids and cholesterol in
a physiologically balanced ratio,
mimicking the lipid concentration
found in the skin, according to the
company. The medication delivers
24-hour barrier repair benefits
with a twice-daily application. The
formulation is steroid-free and
is cleared by the Food and Drug
Administration for the treatment of
atopic dermatitis.

CELLUENCE HAS RELEASED its

Phase Two product, a complement to
its Phase One body cream designed to
tackle cellulite.
Phase Two contains high concentrations of centella asiatica, ascorbic
acid, carnosine, proanthocyanidin,
retinol, green
coffee bean
extract, red pine
bark extract and
other natural
active ingredients, according to
the company. The
ingredients are
formulated to help reduce water retention, glycation, oxidative damage and
connective tissue deformity.
The product complements Phase
One, which also contains 20 active
ingredients to fight cellulite.

PURACAP PHARMACEUTICALS

CELLUENCE

EPICERAM AVAILABLE WITH AIRLESS PUMP DISPENSER

FOR CONTROLLED TREATMENT OF ATOPIC DERMATITIS
PURACAP PHARMACEUTICAL has
added an option to the EpiCeram
product line, with the EpiCeram 225g
Airless Pump.
The pump
dispenser allows
patients to treat any
size area of their
body affected by
atopic dermatitis,
the company states.
The pump system
also allows for more
control, so patients
may precisely and
consistently dispense
the product in a
convenient manner.
The product addition
means patients can

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www.epiceram-us.com

www.celluence.com

ES468392_DT0814_082.pgs 07.23.2014 01:50

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HALOG Cream and Ointment

are designed for a difference
your patients can truly feel.
BIPHASIC CREAm for sustained relief.1,2
PLASTIBASE OINTmENT for enhanced
spreadability and appeal.3
INDICATIONS AND USAGE: Halog (Halcinonide,
USP) 0.1% is indicated for the relief of the
inflammatory and pruritic manifestations of
corticosteroid-responsive dermatoses.
For topical use only.
For Important Safety Information, please see
full Prescribing Information on reverse
and also at HalogRx.com.
REFERENCES: 1. Blecker, J. Double-blind comparison between two
new topical steroids, halcinonide 0.1% and clobetasol propionate cream
0.05%. Curr Med Res opin. 1975;3:225-228. 2. Bagatell FK. Halcinonide:
a new potent anti-inflammatory drug. Cutis. 1974:14:459-462.
3. Thau P, Fox C. a new procedure for the preparation of polyethylenemineral oil gels. J Soc Cosmet Chem. 1965;16:359-363.

Halog is a registered trademark

of Ranbaxy laboratories Inc.
all other trademarks are property
of their respective owners.
HlgJI1 09/13

HAL11891-C_9x12.crw3.indd 1

10/15/13 9:12 AM

HAL11891-C_9x12.crw3.indd 2

10/15/13 9:12 AM

TRADE TOOLS

AUGUST 2014 DERMATOLOGYTIMES.COM

THREE-STEP DAILY
REGIMEN IMPROVES
SIGNS OF HAIR LOSS
THE HAIR REGROWTH SYSTEM
by BrandMD uses a novel threestep daily regimen to improve the
signs of hair loss, according to the
company.
The treatment
system includes
BrandMD's
HRS-10, a biomimetic peptide
that is combined
with red clover
extract. The Hair
Regrowth System's
ingredients and
technology work to stimulate hair
growth and improve hair follicle
anchoring, giving users fuller,
thicker hair.
The HRS-10 technology uses
peptides, essential oils and
extracts, and is safe for use in men
and women.
The hair system is available exclusively to medical professionals for
in-office dispensing.
BRANDMD
www.brandMDskincare.com

MARKERS USE WHITE INK

FOR CLEAR LANDMARKS

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Detox chemical peels

rejuvenate without flaking
GLYCOLIC CHARCOAL DETOX
CHEMICAL PEELS by Bioelements
are acid-hybrid formulas designed
to remove the uppermost layer of the
skin without flaking, pain or downtime, according to the company.
Levels 2 and 3 of the peel system
are ideal for patients with clogged
pores, milia, dull skin, rough skin,
loss of firmness and moderate-tosevere signs of aging and moderate
hyperpigmentation. They contain
lactic acid, glycolic acid and activated charcoal.
The system's Peel Prep Lipid
Eraser helps to eliminate oil, water
and some surface dead skin cells
to accelerate the treatment results
and to provide an even penetration
of the peel formulas, the company
states. It contains extracts of
thyme, burdock, chamomile, sage,
white oak bark and calendula. The
peel system will be available in
September.
BIOELEMENTS
www.bioelements.com/pros

CREAM IMPROVES APPEARANCE OF STRETCH MARKS

VISCOT MEDICAL now offers its

White E-Z Removable Ink, a marker
designed for marking injection sites
and for physician consultations.
The new markers are in white,
complementing Viscot's green and
red E-Z Removable Ink markers. The
ink is easily washable with water or
alcohol swabs.
The markers are available in a
mini-marker trial pack of six, or in
containers of 30.

STRETCH MARK CRME, launched by derma e, is

a physician-developed product that helps to visibly
diminish stretch marks by improving texture, color
and overall appearance.
Using argan oil, cocoa butter, coconut oil and shea
butter, the Stretch Mark Crme conditions the skin to
help boost elasticity and resiliency, the company states.
Vitamin E nourishes the skin to promote healing, while
hyaluronic acid attracts and binds moisture to the skin
to allow for a smoother, softer appearance.
In a small study, participants used the cream two
to three times a day over the course of eight weeks.
Eighty-two percent of participants reported improved
skin texture and smoothness, while 73 percent demonstrated improved color and 100 percent reported their
skin felt fully moisturized. Seventy-three percept of
participants demonstrated an overall improvement in
the appearance of their skin.
The cream is vegan, hypoallergenic, paraben-free,
GMO-free and retinol-free.

VISCOT

DERMA E

www.viscot.com

85

www.dermae.com

ES468391_DT0814_085.pgs 07.23.2014 01:50

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AUGUST 2014 DERMATOLOGYTIMES.COM

Resurfacing peel
fights signs of photoaging

THE NIA 24 Cellular Resurfacing Peel battles the signs of photoaging in a

dual-phase glycolic treatment. Available exclusively through physicians'
offices, the peel is a pre-dosed treatment that detoxifies while also fortifying
and oxygenating the skin, addressing signs of skin aging and sun damage,
according to the company.
The peel helps to reduce the appearance of fine lines, wrinkles, sun damage
and enlarged pores. It contains NIA's Pro-Niacin technology along with an
active blend of potent alpha hydroxy acids and willow bark extract. The
formulation stimulates cellular turnover to revitalize skin; exfoliates dull,
rough surface cells; eliminates pore-clogging impurities; and increases the
skin's natural moisturizing factors, the company states.
NIA 24
www.NIA24.com/peel

WET WRAP GARMENTS SOOTHE SKIN

OF CHILDREN SUFFERING FROM ECZEMA
WRAP-E-SOOTHE wet wrap garments provide a convenient way for
parents and caregivers to provide comfort to children with eczema who
benefit from wet wrap therapy, the company states.
The Wrap-E-Soothe Suit is a full-body outfit for
children ages 6 months to 3 years. The product
line also includes wrap Tops and Bottoms for
children ages 4 to 5, and Sleeves for patients
with problem areas on their hands, feet, legs and
ankles.
The products are manufactured with 94 percent
Tencel/lyocell, a fully sustainable fiber made from
eucalyptus pulp. The fabric is soft and breathable,
according to the company. The clothing can also
be worn dry as anti-inch undergarments to help
soothe irritated skin and to prevent children from
scratching. The garments are machine-washable
and reusable.
AD RESCUEWEAR
www.a d re s c u ewe a r.c o m

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LUXURY SKINCARE
LINE USES NATURAL
INGREDIENTS
SOBO SKIN CARE
has introduced a
new luxury collection of anti-aging
creams, serums
and moisturizers that include
natural ingredients, aimed at
health-conscious
consumers.
The skincare
line includes a
wrinkle cream
containing resveratrol. Other
products include
ceramide 3, hyaluronic acid, lycopene, witch hazel,
seaweed extract, CoQ10 and orange
flower extract.
The product line is free of parabens, sulfates, triclosan, phthalates, GMOs and synthetic dyes and
fragrances.
SOBO SKIN CARE
www.soboskincare.com

SKINCARE SETS PROVIDE

HOME REGIMEN FOR OILY
OR DRY SKIN TYPES
GLO THERAPEUTICS' SKIN SETS
contain cleansers, moisturizers and
masks that
are designed
for those
with oil, dry
or normal
skin types.
Each
skincare set includes a gel cleanser,
a brightening polish, a vital eye
cream, a moisturizer and a mask. The
Normal/Dry collection was designed
to brighten, hydrate and restore
the skin with conditioning plant
extracts. The Normal/Oily collection helps to balance and purify the
skin using light hydrators, botanicals
and refining agents, according to the
company.
GLO THERAPEUTICS
www.gloprofessional.com

ES468390_DT0814_086.pgs 07.23.2014 01:51

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AUGUST 2014 DERMATOLOGYTIMES.COM

upcoming
events

Kansas Society of
Dermatology & Dermatologic
Surgery 2014 Conference

Dermatology Times lists meeting

announcements for the following
three months in our print issue.

AAD 2014 Summer

Academy Meeting

www.kanderm.org
Aug. 23, 2014
Sheraton Hotel
Overland Park, Kansas

XV World Congress
on Cancers of the Skin

www.aad.org
Aug. 6-10, 2014
Hyatt Regency Chicago
Chicago

www.wccs2014.org
Sept. 3-6, 2014
Edinburgh International Conference Centre
Edinburgh, Scotland

Controversies and Conversations

in Cosmetic and Laser Surgery
www.skincarecontroversies.com
Aug. 8-10, 2014
Sun Valley Resort
Sun Valley, Idaho

Oral Dermatology and Oral

Pathology Alaskan Cruise
Conference (CME)
http://www.continuingeducation.net/coursedescription.php?topic=Oral_Dermatology_CME_Alaskan_Cruise_August_2014
Aug. 8-15, 2014
Seattle

Pacific Dermatologic
Association 66th Annual
Meeting
www.pacificderm.org
Aug. 13-17, 2014
Fairmont Hotel Vancouver
Vancouver, British Columbia

LaserInnsbruck 2014
www.laserinnsbruck.com/1/1/english/1/3/
index.htm
Sept. 3-6, 2014
Messe Innsbruck
Innsbruck, Austria

XXII International Pigment

Cell Conference
www.ipcc2014.org
Sept. 4-7, 2014
Shangri-La Hotel
Singapore

44th Annual European

Society For Dermatological
Research Meeting
www.esdr2014.org
Sept. 10-13, 2014
Tivoli Hotel and Congress Center
Copenhagen, Denmark

Practical Dermatology &

Dermatopathology
Symposium
www.dermpath.com/vail
Aug. 14-17, 2014
Vail Marriott Mountain Resort
Vail, Colorado

2014 CalDerm
Annual Meeting

CALENDAR/ AD INDEX

ASDS Total Body

Contouring and Rejuvenation

Laser & Aesthetic Skin

Therapy: Whats the Truth?

www.asds.net/rejuvenation
Sept. 13-14, 2014
Renaissance Chicago Downtown Hotel
Chicago

www.laserskintherapyboston.com
Oct. 10-12, 2014
Seaport Hotel & World Trade Center
Boston

5th World Congress

of Teledermatology

SDEF Womens & Pediatric

Dermatology Seminar 2014

www.teledermatology2014.com
Sept. 18-20, 2014
IDEC-Universitat Pompeu Fabra
Barcelona, Spain

www.globalacademycme.com
Oct. 10-12, 2014
Island Hotel
Newport Beach, California

33rd Annual Meeting

of the Florida Society
of Dermatologic Surgeons

ASDS The Art and Science

of Soft-Tissue Fillers and
Neuromodulators

www.fsds.org/event.php
Sept. 19-21, 2014
Ritz-Carlton Orlando, Grande Lakes
Orlando, Florida

www.asds.net/Fillers
Oct. 25-26, 2014
Adolphus Hotel
Dallas

31st Annual Meeting

of the Ohio Dermatological
Association

World Cutaneous
Malignancies Congress

www.ohderm.org
Sept. 26-28, 2014
Hilton Columbus at Easton
Columbus, Ohio

Pathways to Skin Penetration

www.cfpie.com/showitem.aspx?productid=134
Oct. 6-7, 2014
Hilton Los Angeles Airport
Los Angeles

63rd Annual Montagna

Symposium on Biology of
Skin: Skin Aging

www.calderm.org
Sept. 12-14, 2014
La Costa Resort & Spa
Carlsbad, California

www.cutaneousmalignancies.com
Oct. 29-31, 2014
San Francisco Marriott Marquis
San Francisco

American Society for

Dermatologic Surgery
Annual Meeting
www.asds.net/annualmeeting
Nov. 6-9, 2014
Manchester Grand Hyatt
San Diego

American Society
of Dermatopathology
51st Annual Meeting

www.montagnasymposium.org
Oct. 9-13, 2014
Salishan Spa & Golf Resort
Gleneden Beach, Oregon

www.asdp.org
Nov. 6-9, 2014
Chicago Hilton and Towers, Chicago

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87

88 THE

TAKEAWAY

AUGUST 2014 DERMATOLOGYTIMES.COM

THE IMPORTANCE
OF PATIENT ADHERENCE
ELAINE SIEGFRIED, M.D

Adherence to medication is probably the primary factor that impacts

treatment success. The benefts are most measurable in health
maintenance, disease response and in cost savings. In a series of columns,
Dermatology Times editorial adviser Elaine Siegfried, M.D., discusses a
number of issues surrounding patient adherence with Dr. Steven Feldman.
He is a professor of dermatology at the Wake Forest University School of
Medicine, Winston-Salem, N.C., and a pioneer with regard to adherence.
In part 1, the two discuss the important role adherence plays in patient
management.

DR. SIEGFRIED: In a recent issue of The Dermatologist, you wrote in your editors message
about giving your cell phone number to patients to
encourage adherence.1, 2 Can you talk more about
that? Do you take calls on evenings and weekends?

A:

Yes, I do give out my cell phone

(number), and yes, I do encourage
patients to call me anytime, but I dont
think theyve ever called me late at
night. Giving people my cell phone
number is one of my most powerful
tools to encourage patients to use
medications. Consider scalp psoriasis:
I used to think scalp psoriasis was the
most difficult disease to treat. Nothing
ever seemed to work. Then, I found
that if I told patients to use their
medicine twice a day and come
back to the office in three
days, they would clear up. So
it turns out scalp psoriasis is
incredibly sensitive to treatment if you get people to
adhere to treatment.
Then, instead of making
them come back in three
days, I started having them
call me often on Sundays as I
have clinic on Thursdays to report
their progress. The idea was that this
would force patients to get the medicine and start using it right away. On
top of that, patients would trust me
because I gave them my cell phone
number. When they call on Sunday,
I often do not answer the phone,

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usually because Im busy with family,

or I dont hear it ring. The messages
are almost invariably the same: Dr.
Feldman, I am so glad you didnt pick
up the phone, because I really didnt
want to bother you on a Sunday, but
you said I had to call. I just want to
let you know it worked like a miracle!
My scalp is 90 percent better already.
So you dont need to take the call to
improve adherence, and in fact, the
patient might even prefer if you dont
answer the phone when they call.
I find that people are extraordinarily respectful. Ive talked to other

Giving
people my
cell phone
number
is one of
my most
powerful
tools to encourage
patients to use
medications.
Steven Feldman, M.D.
Winston-Salem, N.C.

dermatologists who are in the habit

of giving surgical patients their cell
phone numbers to call if theres a
problem, and what they tell me is
that those phone numbers tend to be
underutilized patients may have
problems and they dont call.
Now there are probably some
few who will call more often
than others, and if I were getting
a lot of calls from somebody I
might have to establish limits;
I havent had to do that yet

DR. SIEGFRIED: In my office I have two nurses

that are on the phone almost full-time. Its wellstudied that pediatricians spend more time on
the phone than any other specialty, primarily
to reassure anxious parents. So have you done
this for pediatric patients, or do you think the
technique differs in terms with respect to
parents of pediatric patients as opposed to
adult patients?

A:

Yes, parents are more anxious

about their children. Thats
an enormous issue. I do use the
cell phone technique regularly
for parents, too. I used to think
that atopic dermatitis was hard
to control. When I was a resident
I would see patients with atopic
dermatitis who had failed every
single outpatient therapy: the standard topical steroid, the more potent
topical steroid, cyclosporine, metho-

ES468020_DT0814_088.pgs 07.22.2014 03:34

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THE

AUGUST 2014 DERMATOLOGYTIMES.COM

VIDEO

TAKEAWAY

89

dermatologytimes.com
Dr. Feldman discusses how patient psychology is part of
practicing good dermatology. He cites the importance of having
a plan for encouraging patients to begin their medications and
helping patients to continue their medications as use drops
off. View the video and read more at: dermatologytimes.com/
medicationadherence

trexate. But when those patients

were admitted to the hospital on
Friday night with lichenified dermatitis from head to toe, they would
be ready to go back to school on
Monday.
When you admit kids to the
hospital theyre putting the triamcinolone on, and they get better.
Presumably you should be able to
clear up any child of atopic dermatitis with triamcinolone if you
can get the parents to follow the
treatment at home; but parents are
terrified of topical steroids. When
I give them my cell phone number
it reassures them. They can trust
me. If theres a problem, they can
call me.
I have some other tricks for getting
patients with atopic dermatitis to use
the recommended medicine:
First, dont use the word steroid in
front of them. Its a very misleading
word.
Next, tell the parent to put the
triamcinolone on the child for
three or five days and then call you
or your nurse to report the progress. The anticipated call nearly
forces patients to get and use the
triamcinolone. They dont have to
worry about long-term side effects
because theyre going to call you
in three days and youre going to
talk about the results.

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Now, if you have patients calling

your nurses eight hours a day, it
suggests that the patients arent
getting the full information they
need up-front, in a way that is reassuring to them. We did a study on
the callbacks to our office. 3 Our
nurses documented every call, and
we found that most of the calls were
anxious parents with concerns
about isotretinoin. As a result, we
prepared a handout of frequently
asked questions.

DR. SIEGFRIED: Do you think that socioeconomic

factors impact adherence? And if so, do you have
mechanisms to address that?

Presumably, you
should be able to
clear up any child
of atopic dermatitis
with triamcinolone
if you can get the
parents to follow
the treatment at
home.
Steven Feldman, M.D.
Winston-Salem, N.C.

A:

I think there are socioeconomic

factors that impact adherence,
but I dont know that we can count
on anybody to be adherent to treatment. Its the oddball that actually
uses the medicine truly religiously. I
think we have to assume that people
of all socioeconomic statuses are
not using their medicine. I like to
teach my residents to never label
somebody a noncompliant patient
because its redundant. That said,
prescribing unaffordable treatments
is almost certainly going to reduce
patients adherence to treatment.

DR. SIEGFRIED: Can you clarify your feelings about

the word compliant or noncompliant versus
adherent or nonadherent?

A:

I use the words compliance

and adherence interchangeably.

DR. SIEGFRIED: Do you use any measures of adherence and do you document adherence in any way
in your EMR?

A:

For the most part, no, I just

assume that adherence is a
problem. But I sometimes ask
patients about adherence. If you
ask the patient if hes taking his
medicine, he may say, Of course!
But there are ways of telling. For

TAKEAWAY see page 96

ES468630_DT0814_089.pgs 07.23.2014 04:42

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90

Dermatology Times |

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August 2014

marketplace

DermatologyTimes.com

93

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Dermatology Times |

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96 THE

TAKEAWAY

AUGUST 2014 DERMATOLOGYTIMES.COM

ADDITIONAL TAKEAWAYS

A CHANGING LANDSCAPE
The landscape of dermatology
is rapidly changing and every
practicing dermatologist will
almost certainly be affected.
Dermatology Times asked Dirk Elston,
M.D., president of the American Academy
of Dermatology, to address some of these
issues so that we may all have a better
idea of what lies ahead for the specialty.

Listen to the discussion, here.

Send your comments to us:
editor@dermatologytimes.com

DermatologyTimes.com/changinglandscape

TAKEAWAY:
Steven Feldman, M.D., ofers techniques for encouraging
patient adherence from page 89
example, you would think that a
patient with psoriasis so bad he
needs a biologic, would take it regularly. They dont. You can tell by
asking the patient, Are you keeping
the extra syringes youve accumulated refrigerated like youre
supposed to? If he says, Yes and
Ive got about six or eight of them
in the drawer, then you know he
is not using it regularly because he
wouldnt have accumulated any
extras.
When it comes to topical medications, one of the problems we have
is that its very hard to quantify how
much you should go through in a given
period of time. If the patient comes
back for a return appointment three

When it comes
to topical medications, one of the
problems we have
is that its very
hard to quantify
how much you
should go through
in a given period
of time.
Steven Feldman, M.D.

years later with some of a 30-gram

tube remaining, you may want to think
about the possibility that there could
have been poor adherence.
In Denmark they have a single
national pharmacy system. Andreas
Storm, M.D., and colleagues looked
at how long it took patients to fill
prescriptions. 4 They gave patients
with psoriasis, eczema and acne
their prescriptions and then they
went to the pharmacy database to
see how long it took the prescriptions to get filled. They found that
90 percent of acne prescriptions
were filled within one month,
which is pretty good except that
means 10 percent of them did not
get filled. One-third of the prescriptions for atopic dermatitis were not
filled within a month. Half of the
prescriptions for psoriasis were not
filled within a month. I look forward
to the day when we have one giant
health system and the pharmacy
records are right there in the chart
for us to see. DT
References:
1. Feldman SR. The dermatologist. 2014; 22(4):7
2. Feldman SR. Clin Dermatol. 2014;32(3):444447
3. Barnes LE, Al-Dabagh A, Huang WW, Feldman
SR. Dermatol Online J. 2014;20(5):22609
4. Storm A, Andersen SE, Benfeldt E, Serup J. J
Am Acad Dermatol. 2008;59(1):27-33

Winston-Salem, N.C.

Next month: There are a number of factors that infuence whether a patient will
adhere to a treatment regimen. In part 2 of our discussion on adherence,
Drs. Siegfried and Feldman discuss physician-patient relationships as a critical
component and patient satisfaction measurements.

VALUE OF COSMECEUTICALS
Among the diffculties faced
by consumers is the blitz of
advertising of new and presumably
revolutionary products that can
rejuvenate and preserve the youthful appearance
of the skin. Many products make what sound
like medical claims about effcacy. Zoe Draelos,
M.D. the foremost authority on this subject
discusses these issues with Dermatology Times.
DermatologyTimes.com/cosmeceuticals

DOES GLUTEN
DRIVE SKIN DISEASE?
Gluten and gluten-sensitive
enteropathy have become hot
topics among the lay public and in
medical practices. Dermatologists
have historically concerned themselves
with gluten only as it relates to dermatitis
herpetiformis. This may be changing. John Zone,
M.D., from the University of Utah, Salt Lake City,
discusses how gluten sensitive enteropathy
may impact many areas of dermatology.
DermatologyTimes.com/gluten-sensitivity

ADVANCEMENTS IN
PSORIASIS TREATMENT
The past few years have been
an exciting time for those
who treat psoriasis and for
many patients with severe
disease because of excellent new therapies
for this often intractable problem. Alan
Menter, M.D., Baylor University Medical
Center, Dallas, shares insight into recent
developments in the treatment of psoriasis.
DermatologyTimes.com/psoriasisadvances

STRATEGIES FOR
MANAGING LEG ULCERS
Leg ulcers are a common and
diffcult management problem
for all dermatologists. Robert S.
Kirsner, M.D., professor and vice
chairman of dermatology, University of Miami
Miller School of Medicine, and director of the
University of Miami Hospital Wound Center,
elucidates the diagnosis and management
of these challenging skin problems.
DermatologyTimes.com/legulcers
Hear more at: dermatologytimes.com/takeaway-podcasts

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IMPORTANT INFORMATION ABOUT

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MIRVASO Gel is for use in adults ages 18 years and older.
WHAT WARNINGS AND PRECAUTIONS SHOULD I BE AWARE OF?
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have heart or blood vessel problems
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have problems with blood circulation or have had a stroke
have dry mouth or Sjgrens Syndrome
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have irritated skin or open sores
are pregnant or plan to become pregnant. It is not known if MIRVASO Gel
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are breastfeeding. It is not known if MIRVASO Gel passes into breast milk.
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Keep MIRVASO Gel out of the reach of children.
If anyone, especially a child, accidentally swallows MIRVASO Gel, they
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MIRVASO Gel can lower blood pressure in people with certain heart or
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aware of?
These are not all of the possible side effects of MIRVASO Gel. Remind your
patients to call you for medical advice about side effects.
You are also encouraged to report negative side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
HOW SHOULD MIRVASO GEL BE APPLIED?
Remind your patients to use MIRVASO Gel exactly as you instruct them.
They should not use more MIRVASO Gel than prescribed.
Patients should not apply MIRVASO Gel to irritated skin or open wounds.
Important: MIRVASO Gel is for use on the face only. Patients should not
use MIRVASO Gel in their eyes, mouth, or vagina. They should also avoid
contact with the lips and eyes.
Instruct your patients to see the detailed Instructions for Use that come
with MIRVASO Gel for information about how to apply MIRVASO Gel
correctly.
GENERAL INFORMATION ABOUT THE SAFE AND EFFECTIVE USE OF
MIRVASO GEL
Remind your patients not to use MIRVASO Gel for a condition for which it
was not prescribed and to not give MIRVASO Gel to other people, even if they
have the same symptoms. It may harm them.
WHAT ARE THE INGREDIENTS IN MIRVASO GEL?
Active Ingredient: brimonidine tartrate
Inactive Ingredients: carbomer homopolymer type B, glycerin,
methylparaben, phenoxyethanol, propylene glycol, puried water, sodium
hydroxide, titanium dioxide.
WHERE SHOULD I GO FOR MORE INFORMATION ABOUT MIRVASO GEL?
Go to www.mirvaso.com or call 1-866-735-4137
GALDERMA LABORATORIES, L.P.
Fort Worth, Texas 76177 USA
Revised: August, 2013
HCP

Lack of energy, trouble breathing or stops breathing, a slow heart beat,

confusion, sweating, restlessness, muscle spasms or twitching.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF MIRVASO GEL?
The most common side effects of using MIRVASO Gel include:
redness, ushing, burning sensation of the skin, skin irritation
Skin redness and ushing may happen about 3 to 4 hours after applying
MIRVASO Gel. Ask your patients to tell you if they get skin redness and
ushing that is uncomfortable.
Mirvaso and Galderma are registered trademarks.
2013 Galderma Laboratories, L.P.
Galderma Laboratories, L.P.
14501 N. Freeway
Fort Worth, TX 76177
MIR-164B Printed in USA 08/13

black

References: 1. Fowler J Jr, Jackson JM, Moore A, et al; Brimonidine Phase III Study Group. Efcacy
and safety of once-daily topical brimonidine tartrate gel 0.5% for the treatment of moderate to severe
facial erythema of rosacea: results of two randomized, double-blind, vehicle-controlled pivotal studies.
J Drugs Dermatol. 2013;12(6):650-656. 2. Mirvaso [package insert]. Galderma Laboratories, L.P.
Fort Worth, TX; 2013.

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Help your patients with facial erythema of rosacea experience...

Not an actual patient. Individual results may vary. Results are simulated to show a 2-grade improvement of erythema. At hour 12 on day 29, 22% of subjects
using Mirvaso Gel experienced a 2-grade improvement of erythema compared with 9% of subjects using the vehicle gel.*

RAPID AND SUSTAINED ERYTHEMA REDUCTION

BROUGHT TO YOU BY

M I R V A S O ( b r i m o n i d i n e ) T O P I C A L G E L , 0 . 3 3 %
The rst and only FDA-approved topical treatment specically developed and indicated for the facial erythema of rosacea1
Fast results that last up to 12 hours1
The most commonly reported adverse events in controlled clinical studies included erythema (4%), ushing (2%), skin-burning
sensation (2%), and contact dermatitis (1%)2
Important Safety Information
Indication: Mirvaso (brimonidine) topical gel, 0.33% is an alpha-2 adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema
of rosacea in adults 18 years of age or older. Adverse Events: In clinical trials, the most common adverse reactions (1%) included erythema, ushing, skin-burning
sensation, and contact dermatitis. Warnings/Precautions: Mirvaso Gel should be used with caution in patients with depression, cerebral or coronary insufciency,
Raynauds phenomenon, orthostatic hypotension, thromboangiitis obliterans, scleroderma, or Sjgrens syndrome. Alpha-2 adrenergic agents can lower blood pressure.
Mirvaso Gel should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease. Serious adverse reactions following accidental
ingestion of Mirvaso Gel by children have been reported. Keep Mirvaso Gel out of the reach of children. Not for oral, ophthalmic, or intravaginal use.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see brief summary of full Prescribing Information on the following page.

See for yourself. Visit www.mirvaso.com/hcp.

*Phase 3 clinical studies of 553 subjects 18 and older. Subjects were randomized 1:1 to either Mirvaso Gel or vehicle for 29 days. Subjects and clinicians were asked to grade the improvement they saw at 30 minutes and
hours 3, 6, 9, and 12 following application.

Each gram of gel contains 5 mg of brimonidine tartrate equivalent to 3.3 mg of brimonidine free base.

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UNDERSTANDING
THE

PSORIASIS
PATIENT:
A Practical Approach
to Patient Care
EXPERT DISCUSSION CHAIRED BY

Andrew Blauvelt, MD, MBA

Oregon Medical Research Center, Portland, OR

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This promotional supplement is based on a discussion that psoriasis experts had during
the Maui Derm Conference in Hawaii on January 29, 2014. Andrew Blauvelt, MD, chaired
the meeting, which also included Bruce Strober, MD, PhD, Arthur Kavanaugh, MD, and
1HDO%KDWLD0'7KHSDQHOPHPEHUVH[DPLQHGQGLQJVIURPD1DWLRQDO3VRULDVLV
Foundation report on undertreatment and treatment dissatisfaction among patients
with psoriasis and offered insights into ways of optimizing care for these patients. Other
discussion topics were how to establish a good dermatologist-patient relationship and
how to identify and manage the physical and emotional impact of psoriasis on patients.

soriasis is a chronic immune-mediated skin

disease afecting 7.4 million US adults1 and an
estimated 125 million people worldwide.2 Its
efects on the skin, however, are only part of its
impact; psoriasis is linked to arthritis and other
comorbidities, physical and emotional, and it
frequently disrupts interpersonal relationships and work productivity.3-5 Psoriasis has also been linked to elevated cardiovascular morbidity, particularly for patients with more severe

Key Opinion Leader Disclosure Statement:

Dr. Blauvelt is a scientic advisor and clinical study investigator for AbbVie,
Amgen, Anacor, Boehringer Ingelheim, Celgene, Janssen, Lilly, Merck,
Novartis, P]er, and Sando]. Dr. .avanaugh is a clinical trial investigator
for AbbVie, Amgen, BMS, Janssen, P]er, 5oche, and 8CB. Dr. Strober is
a consultant for AbbVie, Amgen, Celgene, Dermira, Janssen, Leo, Lilly,
Maruho, Medac, Merck, Novartis, P]er, StiefelGla[oSmith.line, and 8CB.
He also serves as an investigator for AbbVie, Amgen, Novartis, Lilly, Janssen,
Merck, and a member of the Speakers Bureau for AbbVie. Dr. Strober also
receives grant support from AbbVie and Janssen. Dr. Bhatia is a consultant
for Anacor, Aqua, Bayer, Dusa, Ferndale, Galderma, Leo, Novartis, Promius,
Quinnova, and Valeant. All received honoraria in conjunction with the development of this supplement from Novartis Pharmaceuticals Corporation.
Acknowledgements:
Bruce Strober, MD, PhD, Arthur Kavanaugh, MD, and Neal Bhatia, MD,
contributed to the development of this supplement. Michael Coco, MS, PhD,
under the direction of the author, Andrew Blauvelt, MD, MBA, provided technical
editorial and medical writing assistance to MD On-Line, Parsippany, New
Jersey. Funding for this assistance was provided by Novartis Pharmaceuticals
Corporation, East Hanover, New Jersey.

skin disease.3 Furthermore, according to patient reports, the

disability associated with psoriasis is comparable with that
associated with cardiovascular disease, diabetes, arthritis,
depression, cancer, and other major medical diseases.6
Psoriasis management is generally driven by disease severity. Patients with moderate disease (3%10% of body surface
area [BSA] afected) or severe disease (>10% BSA afected)
are candidates for systemic therapy.7,8 In addition, nontopical
therapeutic approaches may be needed when particular body
regions are involved.8 Te individual patients assessment and
perceptions of his or her disability are also considered when
disease severity and therapeutic choices are being determined.
Tere are now more options for providing efective systemic
treatment for patients with moderate or severe psoriasis.
Development of newer systemic biologic therapies has been
based on improved understanding of the pathogenesis and
immunologic mediators of psoriasis.9
Optimization of psoriasis outcomes depends on improved
dermatologist-patient communication about the best way to
manage the lesions and about any social and emotional issues
the patient may have. Evidence suggests there is too ofen a
gap between patients and dermatologists in their understanding of a wide range of topics, including the disease in general,
all available treatment options and their benefts and risks,
and the presence and extent of emotional distress and associated disability.10-13 Many patients with psoriasis, particularly
those with moderate or severe disease, are dissatisfed with
how their condition is being managed, do not adhere to treatment, do not receive optimal treatment, or receive suboptimal
treatment.14,15

Funding and content assistance provided by Novartis. Copyright 2014 and published by Advanstar Communications Inc. No portion of this publication may be reproduced or
transmitted in any form, by any means, without the prior written permission of Advanstar Communications Inc. The views and opinions expressed in this supplement do not
necessarily reect the views and opinions of Advanstar Communications Inc. or Dermatology 7imes.

2 Understanding the Psoriasis Patient: A Practical Approach to Patient Care

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Psoriasis Undertreatment
and Patient Dissatisfaction
In a 2013 report, the National Psoriasis Foundation (NPF)
highlighted undertreatment and treatment dissatisfaction
rates among patients with psoriasis in the United States.14 Te
reported study, which was based on NPF surveys conducted
biannually from 2003 to 2011, analyzed data from 5604
patients with psoriatic disease who were randomly sampled
from the NPF database and who completed the survey. Of
these 5604 patients, 1286 had mild disease (self-defned as <3
palms of psoriasis), 2031 had moderate disease (3-10 palms),
and 1894 had severe disease (>10 palms). (Tese criteria correspond to the BSA criteria described earlier.)

Psoriasis Undertreatment
Figure 1 shows that 49.2% of patients with mild psoriasis,
23.6% with moderate psoriasis, and 9.4% with severe psoriasis
were not treated for the disease.14 In addition, although a higher percentage of patients with moderate or severe psoriasis
received topical treatment in 2011 than in 20032005, 29.5%
of moderate-disease patients and 21.5% of severe-disease
patients in the 2011 survey received topical treatment alone.
Te NPF guidelines recommend the use of phototherapy, a
systemic agent, or phototherapy plus a systemic agent as treatment for moderate and severe psoriasis.7,8,16 Panel member Dr.
Andrew Blauvelt noted that these data indicate signifcant undertreatment of psoriasis in the United States: Te numbers
may be even worse than they appear, considering that they are
based on responses from members of the NPF registry, who
likely represent more highly motivated and informed patients compared with those generally encountered in clinical
practice.

The numbers may be even worse than they

appear, considering that they are based
on responses from members of the NPF
registry, who likely represent more highly
motivated and informed patients compared
with those generally encountered in clinical
practice.
Andrew Blauvelt, MD, MBA
Less clear from the data are the reasons for undertreatment.
Te panel examined a few potential reasons. First, the term
undertreatment seems to imply that the physician is providing
less than appropriate treatment. In many cases, however, the
physician fully informs the patient of all suitable options, including potential benefts and risks, but the patient, for any of
a variety of reasons, decides to forgo treatment. Some patients
are concerned about side efects, some deny the disease or its
signifcance (they do not want to be sick, and being treated
equals being sick), some do not want to be inconvenienced by
regular administration of therapy, and some are accustomed to
one therapy and do not want to switch to another, even if the
alternative may improve outcomes (these risk-averse patients,
who are better than they were before starting treatment, now
ask, Why risk loss of disease control?).
Te panel concluded that the most the dermatologist can
do in these situations is to fully educate patients about options
and potential benefts, listen to their concerns and address
them as best as possible, and, when treatment refusal is not
in a patients best interest, strongly advocate for a diferent
suitable therapy. With respect to potential drug-related side
efects, the dermatologist must ensure that patients have a

Figure 1. Proportions of National Psoriasis Foundation survey respondents (patients with psoriasis) receiving no treatment or using topical medications alone by severity level.
Psoriasis severity was categorized as mild (<3% body surface area [BSA] psoriasis involvement), moderate (3%10% BSA), or severe (>10% BSA).14 Reprinted with permission.

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clear understanding of the risks and benefts of the treatment

being ofered.
Another set of potential reasons for undertreatment involves physician knowledge and training, and the number of
moderate and severe psoriasis cases in a physicians practice.
Currently, of the roughly 10,000 dermatologists in the United
States, only around 3000 will write biologic prescriptions, and
only about half of those do so on a regular basis, Dr. Blauvelt said. Rheumatologists are better trained in use of the
full range of systemic agents available for moderate to severe
psoriasis, but dermatologists ofen see these patients frst
and they should be more knowledgeable about all options, so
they can be prepared to prescribe them when appropriate. In
a recent study in which 500 NPF members and 500 American
Academy of Dermatology members were surveyed, up to 38%
of the respondents who were treating psoriasis reported they
didnt know the efectiveness associated with various oral
systemic and biologic therapies, and up to 49% didnt know
the likelihood of side efects associated with these agents.17
Although some dermatologists have not been sufciently
trained in biologic therapies and other systemic therapies,
others have simply decided not to use them. Even a busy dermatologist may see only a handful of patients with moderate
or severe psoriasis each month. As Dr. Blauvelt indicated, it
would not be surprising to learn that, among infrequent users
of biologic therapies, there is a general discomfort prescribing
them.

Psoriasis Patient Satisfaction Survey Results

(n=4862 patients)

Figure 2. Proportions of National Psoriasis Foundation 20032011 survey

respondents (patients with psoriasis) who reported dissatisfaction with treatment.14
Adapted from NPF.

the body is unappealing. In a recent cross sectional study on

satisfaction among 1182 patients with moderate or severe
plaque psoriasis, those who received biologic monotherapies,
biologic-methotrexate combinations, or phototherapy had
the highest overall satisfaction scores, and those who received
topical therapy only, or acitretin, had the lowest scores.18 Tese
fndings may provide some reasons for the treatment dissatisfaction that the NPF report identifed among patients with
moderate or severe psoriasis.

Improving Dermatologist-Patient
Communication
You want to be their cheer leader and their
advocate, as well as their sounding board.
Neal Bhatia, MD

Patient Dissatisfaction With Treatment

Besides reporting undertreatment issues, the 2013 NPF report
based on surveys from 2003 to 2011 highlights high rates of
treatment dissatisfaction among patients with psoriasis in the
United States (Figure 2).14 When asked How satisfed have
you been with the treatment you have received for your psoriasis?, 52.3% of patients with psoriasis said they have been
dissatisfed. As for disease severity, 52% of patients with moderate psoriasis, 42.5% with severe psoriasis, and 39.3% with
mild psoriasis reported treatment dissatisfaction (Figure 3).
It may be that, among dissatisfed patients with moderate or
severe disease, the condition has been undertreated (treated
only with a topical agent) and therefore poorly controlled. In
addition, and as the panel members generally agreed, having
to regularly apply a topical agent over a substantial portion of

Good communication between dermatologists and patients

is an important factor in uncovering and addressing patient
dissatisfaction. You want to be their cheer leader and their
advocate, as well as their sounding board, Dr Neal Bhatia
said. Te panel agreed that, ideally, dermatologists must allot
enough time to educate patients about psoriasis and treatment options, and must try to learn of any potential social
or emotional issues their patients may have. With respect to
education, dermatologists typically defne psoriasis, discuss
its potential comorbidities (psoriasis is more than a skin
disease), and lay out the full range of the patients diseasemanagement options.

Social and Emotional Impact of Psoriasis

Optimal management of psoriasis involves addressing comorbidities. We now more clearly understand that psoriasis is a
complex chronic infammatory condition with multiple physical, social, and emotional issues that may have a signifcant
impact on patients personal and professional lives.19 Although
psoriasis treatment is appropriately focused on reducing skin

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Figure 3. Proportions of National Psoriasis Foundation 20032011 survey respondents (patients with different grades of psoriasis severity) who reported treatment
dissatisfaction.14 Reprinted with permission.

lesions while minimizing side efects, patients with psoriasis

should also be assessed for any of the social and emotional
efects of the disease and be ofered any needed treatment.
Emotional issues commonly associated with psoriasis include
anxiety, depression, employment problems, low self-esteem,
negative body image, sexual dysfunction, social difculties or
inhibition, stigmatization, and suicidal ideation.4,5 As these issues may contribute to a patients psoriasis-related disability, it
is important to assess for them and, if needed, to discuss what
can be done.

Social and Emotional Issues

Commonly Associated With Psoriasis
Anxiety
Depression
Employment problems
Low self-esteem
Negative body image
Sexual dysfunction
Social difculties or inJibition
Stigmatization
Suicidal ideation

Identifying Social and Emotional

Issues in Patients
Te panel agreed that the frst step in improving the management of social or emotional issues surrounding a patients

psoriasis is to identify these issues. Out of embarrassment or

another concern, however, patients are ofen reluctant to initiate discussion of these issues. Many times, when a dermatologist begins an examination by asking how the patient is doing,
the quick and uninformative reply is fne. To identify or
otherwise draw out this information, the dermatologist may
need to turn to other strategies or tools.
Dr. Bruce Strober shared that, in his experience, asking a
question such as Are you happy with what were doing? or
How happy are you with the outcomes of what were doing?
usually elicits a fuller, potentially more productive response.
In addition, the panel experts recommended building enough
time into patient visits, particularly the initial visit, to address
both the physical and the emotional components of the disease. Te initial visit may take longer than subsequent visits,
which may not require any extra time. Should scheduling
of longer visits prove difcult, the dermatologist can collect
information about emotional issues in other ways.
One approach is to ask patients 2 simple general questions
in sequencethe frst involving the physical component, and
the second the emotional component.

Two Simple Questions That

Can Make a Difference
1. Thinking about how severe your psoriasis
physical symptoms
sucJ as itcJing aMing
burning, pain) have been over the past week,
how severe have they been on a scale of 0 to 10,
10 being the worst and 0 being no symptoms?
2. Thinking about how severe your psoriasis
emotional symptoms (such as embarrassment,
frustration, and depression) have been over
the past week, how severe have they been on
a scale of 0 to 10, 10 being the worst and 0
being no symptoms?
Te physical issues are addressed frst, because patients
generally perceive them as less threatening. Te dermatologist
asks patients to use a 10-point scale (10 = the worst, 0 = no
symptoms) to describe the extent to which physical symptoms
are bothering them. Subsequent questions address itching,
faking, bleeding, and pain from the disease as well as the
extent and location of lesions. Ten the dermatologist explores
the emotional impact of the disease by asking the patients to
use the same 10-point scale to describe how much embarrassment, frustration, social isolation, anxiety, worry, and other
feelings are bothering them.
Te panel emphasized that nonverbal signs can be useful
in detecting social or emotional issues. Fidgeting, wearing

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season-inappropriate clothing, and not looking the dermatologist in the eye are some of these signs. Lesions on the face
or scalp may be disrupting patients lives more than lesions
on other body areas are. Because many nonverbal signs difer
from person to person, the same sign does not necessarily mean the same thing, but signs do ofer suggestions or
opportunities for further probing. Although not technically
nonverbal, some indirect signs may be informative as well. For
example, a new patient who had seen 2 or more dermatologists before coming to you may have been dissatisfed with the
care received earlier.
Nonverbal signs may be helpful in identifying social
or emotional issues that are affecting the patient
with psoriasis. However, a sign may mean one thing
for patient A but something different for patient B.
Some dermatologists are reluctant to probe a patient with
psoriasis for emotional issues because they perceive it as opening Pandoras box, panel members said. Once an issue is out,
it must be addressed. Other dermatologists are uncomfortable
talking with patients about social stigmatization, depression,
or sexual intimacy issues: Is the dermatologists ofce really
the best place for this discussion? Perhaps most important for
many dermatologists, starting a discussion may give a patient
an opening to bring up many other issues, and there is not
enough time in the schedule to take them all on and have the
practice function properly and remain proftable. Although we
can talk about the ideal from a patient perspective, the reality is that many dermatologists do not have the time to fully
examine and discuss patients emotional issues.
Given such time constraints, yet knowing the benefts of
identifying and managing social or emotional issues in patients with psoriasiscare optimization and increased patient
satisfactiondermatologists should consider other creative
ways to identify and address patients concerns. Te panel suggested 2 possible approaches: enlistment of other dermatology
clinicians and use of patient-reported outcomes and objective
measurement tools.
DErmAtoLogy CLiNiCiANS

Physician assistants (PAs) and nurse practitioners (NPs) can

play an important role in assessing the full impact of psoriasis
on patients lives. For many dermatologists and other physicians whose time with patients is necessarily limited, PAs and
NPs ofer valuable assistance in patient care. For example, in
the days before a dermatologist-patient consultation, a PA
or an NP can speak with the patient and try to identify any
social or emotional issues the patient has been having. If an

emotional issue is identifed, the clinician can discuss it with

the patient and then give the dermatologist a summary report
that can be reviewed before the consultation. Te PA or NP
can also facilitate discussion afer the consultation and try to
answer any of the patients additional questions about treatment options and other topics.
Teledermatology consultations may be another avenue for
patient-expert discussions about social and emotional issues
surrounding psoriasis. One panel expert said that at least one
group, in a study funded by the National Institutes of Health,
is exploring this technological solution. Teledermatology
consultations presumably would also beneft patients who live
in rural or other remote areas with limited access to psoriasis
experts.
PATIENT-REPORTED OUTCOMES AND
objECtivE mEASurEmENt tooLS

Objective measurement tools may be useful in reducing the

time burden that comes with eforts to assess and manage the
emotional and physical efects of moderate and severe psoriasis. Patient-reported outcomes (PRO) questionnaires, for
example, could be used to screen for emotional issues. PRO
questionnaires have already been developed for the exploration of patient satisfaction with treatment outcomes and for
various other uses in psoriasis management, and questionnaires for other uses are in development. PAs and NPs can
easily administer such a questionnaire to a patient, and report
the results to the dermatologist just before the consultation.
PRO data are arguably more useful than physical examination fndings, and in many cases may supplant them, Dr.
Strober suggested. Te problem with physical examination
fndings and other commonly used measures of psoriasis severity, such as BSA and the Psoriasis Area and Severity Index,
is that there is ofen a discrepancy with patient satisfaction
the ultimate aim of care. Some patients have very little disease
but are dissatisfed with their treatment outcome; others have
more involved disease but are satisfed. In other words, the
impact of psoriasis is patient-dependent. PRO data provide
a more direct measure of patient satisfaction as well as clues
to emotional issues negatively afecting the patient. Although
PRO questionnaires must receive further validation before
they can be routinely used in dermatologic practice, they hold
the promise of serving as surrogate markers that can make the
most of time-limited patient visits.
Psychosocial visual analog scales and other quality-of-life
instruments, such as the Dermatology Life Quality Index, may
also have a place in assessing the emotional impact of psoriasis. Te panel suggested that these tests can be administered
by ofce staf, and the results given to the dermatologist before

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he or she enters the consultation room. With these results in

hand, the dermatologist gets an impression of the impact of
psoriasis on the patient and can proceed accordingly.

Clinical Pearls for Selecting

Therapeutic Options
Persistence on just one psoriasis treatment is fairly low. For
this reason, dermatologists provide patients with education
and guidance regarding alternative approaches to disease
management. Patients typically look to dermatologists for
such guidance.
Much panel discussion centered on the criteria for switching or adding therapies. Panel members agreed that prescribing alternative treatment options is an art involving many
factors. Changes in efectiveness and safety are important, but
so is the patients satisfaction with the therapy he or she has
now. Te patient may or may not think that a relatively small
decrease in efectiveness is reason enough to alter therapy. Te
dermatologist may consider a change when (1) an alternative
therapy might be more efective for a long-standing patient
whose disease control is suboptimal, (2) a therapy is insuffciently efective or is producing troublesome side efects, or
the patient for some other reason is no longer satisfed with
it, or (3) a therapy has lost its efectiveness or is now linked
to safety or tolerability issues. According to Dr. Blauvelt, a
simple way to quickly assess treatment satisfaction is to ask
the patient if he or she is clear and without side efects. If the
answer is yes, treatment continues; if the answer is no, treatment is reassessed.

Consider treatment change when:

An alternative therapy might be more
effective.
A recently initiateF therapy is insWfciently
effective or is intolerable.
A therapy has lost its effectiveness or has
become intolerable or unsafe.
Panel members also agreed that, in their practices, movement to an alternative therapy tends to be a gradual processoccurring over 2 or more consultations with the patient,
following trends in treatment efectiveness, and taking into
account safety issues. Patient dissatisfaction with a therapy
tends to be given more weight than a specifc trigger (eg, a
signifcant change in afected BSA) when alternative treatment
options are being considered.
With respect to timing, panel members agreed that 3 to
6 months is generally a good point at which to evaluate and
consider changing a therapy that is inefective. Terapy change

may also be considered when there has been a reduction in

disease control. (Note that some patients are more concerned
about losing the control they have than about improving
it.) Further, which area is afected by the reduction in controlscalp, palms, legs, genitals, or other visible or sensitive
areamay also alter patient perceptions. Te evaluation can
be highly patient-dependent.
Patients with psoriasis generally are more receptive to considering diferent therapies, or even eager to consider them,
once they have perceived a reduction in control. Teir willingness is driven less by the prospect of improving control. As
Dr. Arthur Kavanaugh said, Psychologically, people are more
willing to do something to prevent getting worse than they are
to get better. So if you say, If you dont do this, youre going to
get worse, you could probably get more people to consider al-

Psychologically, people are more willing

to do something to prevent getting worse
than they are to get better. So if you say,
If you dont do this, youre going to get
worse, you could probably get more
patients to consider alternative treatment
options than if you say, Well, youre doing
okay, but you could do better.
Arthur Kavanaugh, MD

ternative treatment options than if you say, Well, youre doing

okay, but you could do better. Patients become anxious when
it appears they might be losing whatever psoriasis control they
have, especially when a signifcant amount of time and efort
went into getting to that point. When presented with the prospect of improved control, they are more likely to consider how
satisfed they are now, and to weigh whether possible improvement is worth the treatment change and whatever might occur
with it.
Relationships with past and present dermatologists can also
infuence a patients receptiveness to alternative treatment options. For instance, a patient who has a positive psychological
bond with one dermatologist may resist seeking another, or
making any other move to change therapy, even therapy that
has been suboptimal. Te patient may also feel guilty about
leaving the doctors practice, even if not completely satisfed
with the care receivedhe or she improved to some degree
there, afer all.
Similar issues can arise when a patients longtime prescriber
recommends changing treatment options. It is therefore important that the dermatologist lay out treatment expectations

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for the patient at their frst and subsequent meetings. Te

dermatologist should make it clear that psoriasis treatment is
not simple and that fnding the best therapy may take some

It is important for the dermatologist to

create a relationship where the patient feels
comfortable saying that the treatment does
not work. Andrew Blauvelt, MD, MBA

time. Patient and dermatologist need to collaborate to try to

achieve the treatment goals that are set. In this collaboration,
the patient needs to give the dermatologist an honest sense of
his or her satisfaction with treatment. It is important for the
dermatologist to create a relationship where the patient feels
comfortable saying that the treatment does not work, Dr.
Blauvelt suggested. It is critical to establish a feeling of trust
and openness at the initial visit in particular. Tis will pay
large dividends in the future.

Summary and Conclusions

Psoriasis is a chronic infammatory skin disease that is ofen
accompanied by physical, social, and emotional issues. Recent
data from the NPF report and other studies suggest that many
patients with psoriasis are both undertreated and dissatisfed
with how their condition is being managed.
In this article, psoriasis experts have reviewed these fndings and presented their recommendations to help improve
dermatologist-patient communication. In particular, they
have drawn on their clinical experience to suggest better ways
to identify psychological, emotional, and social issues that
may negatively impact their patients with psoriasis. Te panel
members also discussed how improved communication can
help in recognizing the need for alternative approaches to
management. By following these recommendations, dermatologists will be better able to identify psoriasis patients sources
of dissatisfaction and provide more efective treatment. ///

REFERENCES
1.

2.

3.

4.
5.

6.

7.

Rachakonda TD, Schupp CW, Armstrong AW.

Psoriasis prevalence among adults in the United
States. J Am Acad Dermatol. 2014;70(3):512-516.
National Psoriasis Foundation. Statistics. http://
www.psoriasis.org/learn_statistics. Accessed
February 11, 2014.
Horreau C, Pouplard C, Brenaut E, et al.
Cardiovascular morbidity and mortality in psoriasis
and psoriatic arthritis: a systematic literature review.
J Eur Acad Dermatol Venereol. 2013;27(suppl
3):12-29.
Green L. An overview and update of psoriasis. Nurs
Stand. 2011;25(35):47-55.
Hong J, Koo B, Koo J. The psychosocial and occupational impact of chronic skin disease. Dermatol Ther.
2008;21(1):54-59.
Rapp SR, Feldman SR, Exum ML, Fleischer AB
Jr, Reboussin DM. Psoriasis causes as much
disability as other major medical diseases. J Am
Acad Dermatol. 1999;41(3 pt 1):401-407.
Van Voorhees A, Feldman SR, Koo JYM, Lebwohl
MG. The Psoriasis and Psoriatic Arthritis Pocket
Guide: Treatment Algorithms and Management
Options. 3rd ed. Portland, OR: National Psoriasis
Foundation; 2009. http://www.psoriasis.org/
document.doc?id 354. Accessed April 25, 2014.

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936-1080

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8.

9.

10.

11.

12.

13.

Mrowiet] U, Kragballe K, Reich K, et al. Denition

of treatment goals for moderate to severe
psoriasis: a European consensus. Arch Dermatol
Res. 2011;303(1):1-10.
Villaseor-Park J, Wheeler D, Grandinetti L.
Psoriasis: evolving treatment for a complex disease.
Cleve Clin J Med. 2012;79(6):413-423.
Picardi A, Amerio P, Baliva G, et al. Recognition of
depressive and anxiety disorders in dermatological
outpatients. Acta Derm Venereol. 2004;84(3):213217.
Richards HL, Fortune DG, Weidmann A, Sweeney
SK, Grifths CE. Detection of psychological distress
in patients with psoriasis: low consensus between
dermatologist and patient. Br J Dermatol.
2004;151(6):1227-1233.
Sampogna F, Tabolli S, Abeni D; IDI Multipurpose
Psoriasis Research on Vital Experiences (IMPROVE)
Investigators. The impact of changes in clinical
severity on psychiatric morbidity in patients
with psoriasis: a follow-up study. Br J Dermatol.
2007;157(3):508-513.
Uhlenhake EE, Kurkowski D, Feldman SR. Conversations on psoriasiswhat patients want and what
physicians can provide: a qualitative look at patient
and physician expectations. J Dermatolog Treat.
2010;21(1):6-12.

2014 Novartis

Printed in USA

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14.

15.

16.

17.

18.

19.

Armstrong AW, Robertson AD, Wu J, Schupp C,

Lebwohl MG. Undertreatment, treatment trends,
and treatment dissatisfaction among patients
with psoriasis and psoriatic arthritis in the United
States: ndings from the National Psoriasis
Foundation surveys, 20032011. JAMA Dermatol.
2013;149(10):1180-1185.
Augustin M, Holland B, Dartsch D, Langenbruch
A, Radtke MA. Adherence in the treatment of
psoriasis: a systematic review. Dermatology.
2011;222(4):363-374.
Baker C, Mack A, Cooper A, et al. Treatment goals
for moderate to severe psoriasis: an Australian
consensus. Australas J Dermatol. 2013;54(2):148154.
Abuabara K, Wan J, Troxel AB, et al. Variation in
dermatologist beliefs about the safety and effectiveness of treatments for moderate to severe psoriasis.
J Am Acad Dermatol. 2013;68(2):262-269.
Callis Dufn K, Yeung H, Takeshita J, et al. Patient
satisfaction with treatments for moderate-to-severe
plaque psoriasis in clinical practice. Br J Dermatol.
2014;170(3):672-680.
Li K, Armstrong AW. A review of health outcomes
in patients with psoriasis. Dermatol Clin.
2012;30(1):61-72, viii.

XDP-1300609

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THE 2014 PSORIASIS SUPPLEMENT TO

AUGUST 2014

Vol. 35, Supp. 2

Clinical Analysis for Todays Skincare Specialists

www.dermatologytimes.com

TREATING
WHOLE
PATIENT
THE

The psychosocial burden of

psoriasis shouldnt be ignored...

I TRIED TO HIDE
MY CONDITION SO
I DIDNT HAVE TO
EXPLAIN MYSELF.

Skin is as
important
to us as it
is to you.
So at
Celgene,
were bringing
our scientific
expertise and
innovative thinking
to dermatology.
Its our commitment
to help you help
your patients.

2014 Celgene Corporation 07/14 USII-CELG130017d

THE 2014 PSORIASIS SUPPLEMENT TO

AUGUST 2014

Vol. 35, Supp. 2

Clinical Analysis for Todays Skincare Specialists

www.dermatologytimes.com

TREATING
WHOLE
PATIENT
THE

The psychosocial burden of

psoriasis shouldnt be ignored...

I TRIED TO HIDE
MY CONDITION SO
I DIDNT HAVE TO
EXPLAIN MYSELF.

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ONE TOUGH SPRAY

A super-potent spray for moderate to severe plaque psoriasis

Patient pictured was not a participant in the Phase 3 clinical studies for Topicort Topical Spray. Individual results may vary. Photos and notes provided by J. Bikowski, M.D.1

BASELINE LEG

AFTER 4 WEEKS OF TREATMENT

Erythematous, scaling plaques on anterior left leg.

Lesions decreased in thickness and scale.

Topicort Topical Spray is a topical corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.
Important Safety Information
Topicort Topical Spray is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid
insuciency. This may occur during treatment or upon withdrawal of the topical corticosteroid.
Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for
HPA axis suppression.
Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions
may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral
dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local reactions may be irreversible.
Safety and eectiveness of Topicort Topical Spray in patients younger than  years of age have not been studied therefore use in pediatric
patients is not recommended.
1. Data on le, Taro Pharmaceuticals U.S.A., Inc.

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See brief summary of Prescribing Information on reverse side.

2014 Taro Pharmaceuticals U.S.A., Inc.
TaroPharma and Topicort are registered trademarks of Taro Pharmaceuticals U.S.A., Inc.

AD100-0036

June 2014

ES472317_DTSUPP0814_CV2_FP.pgs 07.25.2014 23:31

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TOPICORT (desoximetasone) Topical Spray, 0.25%

Rx Only

Table 1. Number (%) of Subjects with Adverse Reactions Occurring in 1%

Topicort Topical Spray,

0.25% b.i.d. (N = 149)

Vehicle spray b.i.d.

(N = 135)

Number of Subjects with

Adverse Reactions

13 (8.7%)

18 (13.3%)

4 CONTRAINDICATIONS
None

Application site dryness

4 (2.7%)

7 (5.2%)

Application site irritation

4 (2.7%)

5 (3.7%)

5 WARNINGS AND PRECAUTIONS

5.1 Efect on Endocrine System
Topicort Topical Spray is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitaryadrenal (HPA) axis.

Application site pruritus

3 (2.0%)

5 (3.7%)

BRIEF SUMMARY
1 INDICATIONS AND USAGE
Topicort Topical Spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of
age or older.

Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential
for glucocorticosteroid insuciency. This may occur during treatment or upon withdrawal of the topical
corticosteroid.
In a study including 21 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis,
adrenal suppression was identied in 1 out of 12 subjects having involvement of 10-15% of body surface area
(BSA) and 2 out of 9 subjects having involvement of >15% of BSA after treatment with Topicort Topical Spray
twice a day for 28 days. [see Clinical Pharmacology (12.2)]
Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be
periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid
to HPA axis suppression include the use of high potency steroids, larger treatment surface areas, prolonged use,
use of occlusive dressings, altered skin barrier, liver failure and young age.
An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression.
If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce
the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insuciency may
require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete
upon discontinuation of topical corticosteroids.
Cushings syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic
absorption of topical corticosteroids.
Use of more than one corticosteroid-containing product at the same time may increase the total systemic
corticosteroid exposure.
Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. [see Use in
Specifc Populations (8.4)]
5.2 Local Adverse Reactions with Topical Corticosteroids
Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency
corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness,
folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary
infection, and miliaria. Some local adverse reactions may be irreversible.
5.3 Allergic Contact Dermatitis with Topical Corticosteroids
Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal
rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be conrmed by patch
testing.
5.4 Concomitant Skin Infections
Concomitant skin infections should be treated with an appropriate antimicrobial agent.
If the infection persists, Topicort Topical Spray should be discontinued until the infection has been
adequately treated.

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at
relatively low dosage levels.
Desoximetasone has been shown to be teratogenic and embryotoxic in mice, rats, and rabbits when given by
subcutaneous or dermal routes of administration at doses 3 to 30 times the human dose of Topicort Topical
Spray based on a body surface area comparison.
8.3 Nursing Mothers
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with
endogenous corticosteroid production, or cause other untoward eects. It is not known whether topical
administration of corticosteroids could result in sucient systemic absorption to produce detectable quantities
in breast milk. Because many drugs are excreted in human milk, caution should be exercised when Topicort
Topical Spray is administered to a nursing woman.
If used during lactation, Topicort Topical Spray should not be applied on the chest to avoid accidental ingestion
by the infant.
8.4 Pediatric Use
Safety and eectiveness of Topicort Topical Spray in patients younger than 18 years of age have not been
studied; therefore use in pediatric patients is not recommended. Because of a higher ratio of skin surface area to
body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushings syndrome
when they are treated with topical corticosteroids. They are therefore at greater risk of adrenal insuciency
during andor after withdrawal of treatment. Adverse eects including striae have been reported with
inappropriate use of topical corticosteroids in infants and children. [see Warnings and Precautions (5.1)]
HPA axis suppression, Cushings syndrome, linear growth retardation, delayed weight gain, and intracranial
hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal
suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation.
Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
[see Warnings and Precautions (5.1)]
8.5 Geriatric Use
Clinical studies of Topicort Topical Spray did not include sucient numbers of subjects aged 65 years and over
to determine whether they respond dierently from younger subjects. Other reported clinical experience has
not identied dierences in responses between the elderly and younger patients. In general, dose selection for
an elderly patient should be cautious, usually starting at the low end of the dosing range, reecting the greater
frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
10 OVERDOSAGE
Topicort Topical Spray can be absorbed in sucient amounts to produce systemic eects. [see Warnings and
Precautions (5.1)]

5.5 Flammable Contents

Topicort Topical Spray is ammable; keep away from heat or ame.
ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the
clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not
reect the rates observed in practice.
In randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate to severe
plaque psoriasis of the body applied Topicort Topical Spray or vehicle spray twice daily for 4 weeks. A total of
149 subjects applied Topicort Topical Spray.
Adverse reactions that occurred in 1% of subjects treated with Topicort Topical Spray were application site
dryness (2.7%), application site irritation (2.7%) and application site pruritus (2.0%).
Another less common adverse reaction (<1% but >0.1%) was folliculitis.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy
Teratogenic &ects: Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women. Topicort Topical Spray should be used
during pregnancy only if the potential benet justies the potential risk to the fetus.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information and Instructions for Use)
Inform patients of the following:
Use this medication as directed by the physician.
Topicort Topical Spray is for external use only. Avoid use on the face, axilla or groin.
Do not use this medication for any disorder other than that for which it was prescribed.
Do not bandage or otherwise cover or wrap the treated skin so as to be occlusive.
Report any signs of local or systemic adverse reactions to the physician.
Do not use other corticosteroid-containing products with Topicort Topical Spray without rst consulting
with the physician.
Discontinue therapy when control is achieved. If no improvement is seen within 4 weeks, contact
the physician.
This medication is ammable; avoid heat, ame, or smoking when applying this product.
Discard this product 30 days after dispensed by pharmacist.
Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
Dist. by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532
Revised: April 2013
AD100-0030

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Psoriasis unsPoken Pain

More than

sKin dEEp
PHOTO: GETTYIMAGES/BALLYSCANLON/ PHOTOGRAPHERS CHOICE RF

The psychosocial burden of psoriasis

is well documented and shouldnt
be ignored by dermatologists.
Managing these patients requires
more than prescribing drugs,
light therapy and topicals,
experts say
lisette hilton | senior staff Correspondent

AU G U ST 2014

M
4

any doctors, including dermatologists,

would rather not address patients feelings
about psoriasis. Its part of how dermatologists protect themselves
from bearing the burdens of patients
woes, according to Richard Fried,
M.D., Ph.D., a dermatologist and
clinical psychologist in Yardley,
Pennsylvania.
When we first introduce psychological burden or psychological
impact of psoriasis, often eyes start
Dr. Fried
to roll. Blah, blah, blah, Ive heard
it a hundred times: Psoriasis sucks. So does acne. So
does eczema, Dr. Fried says. (The reaction represents
dermatologists) self-protective mechanism. It tries to

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protect us from getting damaged, drained, hurt, to the

point where were too exhausted or too emotionally
wounded to do our jobs.
Its a lot easier, he says, to assess a patients physical
condition and write a script. One might give a reassuring nod and say, Thats psoriasis by the way. Its not
contagious. Dont worry about it.
Thats very different than hearing and feeling their
stories, Dr. Fried says.
When it comes to treating and managing psoriasis
patients, ignoring the psychosocial aspect is akin to
ignoring the elephant in the room. Researchers have
found the psychosocial effects of psoriasis can equal
those experienced with heart failure or cancer. And
thats a big problem, given psoriasis is the common
autoimmune disease in the United States. As many as
7.5 million Americans have the condition, according to
the National Psoriasis Foundation (NPF).

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DermatologyTimes

according to Steven R. Feldman, M.D., Ph.D., professor

of dermatology at Wake Forest University School of
Medicine, Winston-Salem, North Carolina.
Having psoriasis affects self-esteem, impacts
emotion and diminishes quality of life, according to a
survey of 4,725 patients with psoriasis conducted by the
NPF. Among the findings of the telephone and Internet
surveys conducted from 2004 through 2009:
More than 70 percent of respondents reported
feeling self-conscious about their psoriasis;
41 percent said they dress to conceal the lesions;
56 percent said psoriasis interferes with their
capacity to enjoy life; and
63 percent revealed the skin disease impacts their
overall emotional well-being.
Nearly 60 percent said psoriasis was a large
problem in their everyday lives.
Women surveyed report suffering psychosocially

whEn wE first introducE psychological

BurdEn or psychological impact of psoriasis,
oftEn EyEs start to roll. ... ivE hEard it
a hundrEd timEs.
Richard Fried, m.D., Ph.D.
Yardley, Pennsylvania

Concretely, these are people who are at higher

risk for and higher occurrence of suicide. These are
people who suffer with much greater levels of depression, anxiety, social isolation, unemployment, marital
impairment, sexual impairment, disorders obviously
contributing to or from very impaired self-image, Dr.
Fried says. Its important that, as dermatologists, we
are reminded of how big a deal this is. And its important
that we have in the forefront of our clinical decision
making ideas and plans for what we can do to decrease
the burden in a given individual.

Psoriasis affects the way people perceive themselves.

It affects how people are perceived by others. And it
affects how people think other people perceive them,

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AU G U ST 2014

anEcdotal, sciEntific EvidEncE

more than men. For example, 71 percent of women

said they were embarrassed and 73 percent said
they felt helpless because of their psoriasis. That was
compared to 65 percent of men who felt embarrassed
and 69 percent of men who felt hopeless because of it.
Women, according to the NPF, are particularly sensitive about how psoriasis affects their appearance.
The NPF reports that, like women, minorities with
psoriasis seem to suffer more psychosocially. This could
be explained, in part, because of a greater prevalence of
very severe disease in the minority respondent group.
For example, nearly a quarter of African-American
respondents had very severe psoriasis. Among those
findings: 72 percent of minority respondents said psoriasis interfered with their capacity to enjoy life, compared
with 54 percent of Caucasians.
In general, younger people
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Psoriasis unsPoken Pain

seem to be more affected than their older counterparts with psoriasis. Among the striking findings: 84
percent of those ages 20 to 39 said they felt angry or
frustrated by psoriasis, versus 69 percent of respondents older than 40, according to the NPF.

AU G U ST 2014

EntEr dEprEssion, othEr illnEssEs

Psychiatric comorbidities associated with psoriasis

often go undetected and untreated, and psoriasis is
more highly associated with psychiatric illness than
other dermatologic conditions, according to a review
by Rieder and Tausk (Rieder E, Tausk, F. Int J Dermatol.
2012;51(1):12-26).
Dr. Feldman and others have looked at rates of
suicide and depression in patients with psoriasis and
found both to be higher than among controls.
In our survey of patients with psoriasis, 10 percent
had thought about committing suicide due to their
psoriasis at some point in their lives, Dr. Feldman says.
In a large United Kingdom study published August
2010 in Archives of Dermatology, researchers found
that compared to controls, psoriasis patients were
39 percent more likely to be clinically diagnosed
with depression, were at 31 percent higher risk for
anxiety and at 44 percent increased risk of suicidality
(Chosidow O, Dellavalle RP, Do D, et al. Arch Dermatol.
2010;146(8):896-902).
The psychosocial distress people feel as the result
of psoriasis is not necessarily associated with how
severe the disease is. Harvard researchers published
a review in the American Journal of Clinical Dermatology suggesting that social stigmatization, high
stress levels, physical limitations, depression, employment problems and other psychosocial comorbidities
experienced by patients with psoriasis are not always
proportional to, or predicted by, other measurements
of disease severity such as body surface area involvement or plaque severity (Kimball AB, Jacobson C,
Weiss S, et al. Am J Clin Dermatol. 2005;6(6):383-392).
The psychosocial burden of psoriasis has farreaching effects. One is economic impact. The NPF
found that of the 40 percent of respondents who were
not working at the time of the survey, more than a
quarter said their lack of employment was due wholly
or in part to their psoriasis and/or psoriatic arthritis.
Researchers have found more than 17 percent of
patients, ages 18 to 54, report psychological effects in
the workplace due to their disease (Krueger G, Koo J,

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Lebwohl M, et al. Arch Dermatol. 2001;137(3):280-284).

Italian researchers reported in August 2013 that 55
percent of the 787 psoriasis patients in their study had
limited expectations of career progression. About 60
percent of patients revealed psoriasis on their hands or
feet caused work limitations. About a quarter reported
it caused them to quit their jobs (Ayala F, Sampogna
F, Romano GV, et al. J Eur Acad Dermatol Venereol. 21
Aug 2013 [Epub ahead of print]).

EmErging rEsEarch
Experts agree that more research needs to be done on
the psychosocial impacts of psoriasis and how to better
manage patients. Researchers are making headway,
however, in causes and potential treatments.
Francisco Tausk, M.D., professor of dermatology
and psychiatry, University of Rochester, New York, and
former president of the Association of Psycho-neurocutaneous Medicine of North America, and colleagues
presented a recent mouse study looking at the effect
of stress on psoriasis. His research, Dr. Tausk says,
supports the idea that not all patients psoriasis gets

a worldwide issue
The psychiaTric comorbidiTies associated
with psoriasis deserve more attention from physicians
around the globe, experts say.
In a large population-based study published in
Archives of Dermatology, researchers reported people
with psoriasis have increased risks of depression,
anxiety and suicidality. They estimated that psoriasis in
the United Kingdom is responsible for more than 10,400
diagnoses of depression, 7,100 diagnoses of anxiety
and 350 diagnoses of suicidality (Kurd SK, Troxel
AB, Crits-Christoph P, Gelfand JM. Arch Dermatol.
2010;146(8):891-895).
The authors, including researchers from the
University of Pennsylvania, concluded its important for
clinicians to evaluate psoriasis patients for these conditions to improve outcomes. They recommend future
research focus on mechanisms by which psoriasis is
associated with psychiatric outcomes, as well as how
to prevent psychiatric comorbidities.

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worse with stress. The subgroup of patients that suffer

post-stress flairs are most likely people who respond to
stress with lower cortisol amounts (Richards HL, Ray
DW, Kirby B, et al. Br J Dermatol. 2005;153(6):1114-1120).
Dermatologists might use this information in practice, he says, by understanding which patients would
likely benefit most from stress reduction interventions.
Dr. Tausk also recently finished a study on the effects
of mindfulness-based stress reduction on psoriasis.
While the results of this study had not yet been
analyzed, the new study was based on one done years
ago by John Kabat-Zinn, Ph.D. (Kabat-Zinn J, Wheeler E,
Light T, et al. Psychosom Med. 1998;60(5):625-632).
Dr. Kabat-Zinn looked at two psoriasis patient
groups. One group received phototherapy only; the
other, phototherapy and mindfulness meditationbased stress reduction intervention guided by audio-

.com

DermatologyTimes

thE dErmatologists rolE

The impact of psoriasis comorbidities on quality of life
is an issue that is not commonly addressed by primary
care physicians and subspecialists during regular
visits. This omission represents a crucial gap in knowledge, creating a barrier to the effective treatment and
well-being of these patients, Dr. Tausk says.
In a review published in 2013 in Dermatology
and Therapy, researchers reported, Psoriasis has a
profound impact on mental health and well-being,
which is under-recognized by clinicians.
The U.K. researchers conducting the review wrote
in the discussion that despite high levels of psychological distress among psoriasis patients, only 4 percent
of dermatology units in the U.K. provide dedicated
counseling services (Moon HS, Mizara A, McBride SR.
Dermatol Ther (Heidelb). 2013;3(2):117-130).

in our survEy of patiEnts with psoriasis,

10 pErcEnt had thought aBout committing
suicidE duE to thEir psoriasis at somE point
in thEir livEs, dr. fEldman says.
taped instructions during light treatments. The mindfulness meditation group cleared in half the time,
according to Dr. Tausk.
It shows that a very simple intervention can not only
help the patients emotionally and psychologically but
also help their skin disease, Dr. Tausk says.
Future research might have more emphasis on
mental health aspects of psoriasis. The NPF is calling
on the National Institutes of Health (NIH) to get more
involvement with the National Institutes of Mental
Health (NIMH) because it is believed that psoriasis
studies and treatment should routinely have input from
the NIMH, Dr. Fried says.
This is going to very high levels at this point with
the recognition that it is leaving out an essential part of
the equation not to have mental and emotional impact
assessment for psoriasis patients, he says.

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Obviously, the dermatologists role is to clear the

lesions, Dr. Feldman says. But thats not the first step in
that patients care.
Step one with psoriasis patients is not to understand
whether they have localized or generalized psoriasis.
And step one is not to determine whether they need
referral to a rheumatologist, according to Dr. Feldman.
Step one in a psoriasis patient is to address the
psychosocial needs of the patient, he says. I think
dermatologists, as part of the treatment, should be
expected and should hold themselves (responsible) for
addressing those psychosocial issues.

But how?
Dermatologists can help patients address psychosocial
needs simply by recommending they join the NPF. Dr.
Feldman suggests all his patients continued on next page

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Psoriasis unsPoken Pain

effective treatment can help

Dr. Feldman

dr. Feldman was among the authors of a study

in the september 2010 issue of the Journal of
the American Academy of Dermatology, which
found ustekinumab significantly improved anxiety,
depression and skin-related quality of life in patients
with moderate-to-severe psoriasis. researchers
followed the 1,230 patients in the study for 24 weeks.

AU G U ST 2014

www.ncbi.nlm.nih.gov/pubmed/20462664

get involved. The foundation offers credible information, support and comfort in knowing theyre not alone,
he says.
Simple and quick strategies can help a dermatologist determine the extent to which a psoriasis patient is
psychosocially affected by the skin disease.
Dr. Feldman says he screens his psoriasis patients
for depression at every visit. He assesses their mood,
in part, by watching their behavior. Lack of eye contact
and paucity of movement are clues they might be
depressed.
If you get the sense theyre depressed, you can
quickly ask them a screening question or two, Dr.
Feldman says.
He says his favorite questions (because theyre not
very confrontational) are asking patients if theyve
had trouble sleeping and about their energy level. If
those issues are problems, hell follow up with the more
pointed questions, asking if patients think theyre
depressed or if they feel suicidal.
If you identify signs of depression, then you need
to get them to their primary care doctor for treatment,
and, if its severe, perhaps psychiatry, Dr. Feldman
says.
The dermatologists treatment plan should include
getting the disease under better control, giving the
person affected a sense of enhanced control and
offering more information and opportunity for them to
address some of the psychologic or psychiatric morbidi-

ties, according to Dr. Fried. In addition to looking into

the NPF, dermatologists might recommend support
groups or that patients engage in stress management
modalities shown to make traditional therapies work
better, such as progressive muscle relaxation, guided
imagery, mindfulness meditation, self-hypnosis, yoga
and tai chi, he says.
Dermatologists might also refer patients to psychologists, social workers or psychiatrists, according to Dr.
Fried.
There are many studies that show that cognitive
behavioral psychotherapy has very substantial benefits
in terms of making people get better much more quickly,
with less treatment. Even antidepressive medications play
a significant role, he says. There are fewer controlled
studies using antidepressant medications but there is no
question that they can be extremely beneficial.
Rather than looking at probing into potential psychosocial issues and making referrals as more responsibilities on doctors shoulders, dermatologists should look
at the practice as empowering themselves and their
patients, Dr. Fried says.
If we dont feel empowered, in control and like we
have something to offer in a given arena, were going to
run from it, he says. My position has always been (as a
psycho-dermatologist) that dealing with feelings does
not necessarily have to be a time-consuming endeavor.
Dealing with feelings can be as simple as validating
how difficult it is. DT

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TIPS FOR ADDRESSING PATIENTS PSYCHOSOCIAL NEEDS

JUST ASK

HOLD EYE CONTACT

Richard Fried, M.D., Ph.D., a dermatologist and
clinical psychologist in Yardley, Pennsylvania, gives
patients what he calls the two-second eye test. He
prompts patients with a question such as: Is it
tough living with psoriasis? Then, he says,
I hold eye contact for two seconds and say,
Honestly, is it tough?
The eye contact, he says, evokes a degree
of discomfort, which often results in the patients
admitting their feelings, he says. DT

AU G U ST 2014

Clinical health psychologist and

psoriasis patient Madelyn PetrowCohen, M.A., L.C.S.W., offers these
tips for delving into how psoriasis
might affect patients emotionally.
Ms. Petrow-Cohen practices
Ms. Cohen
psychology in Greenwich Village,
New York, and Maplewood, New
Jersey.
I think one of the questions I would have right away,
up-front, is, How is this impacting your daily life?
How is this impacting how you feel about yourself
and others? So, you right away give the message to the
client, to the patient, that you understand a little bit of what
theyre going through.

Consider asking about the psychosocial impact of

the disease on one of the forms patients fill out. One
question might be: How is this condition affecting
you psychologically?

15

Psoriasis unsPoken Pain

Patients

pErspEctivE
A patient with psoriasis asks dermatologists to
put themselves in their patients shoes and look
at the condition from that viewpoint.
lisette hilton | senior staff Correspondent

rian Lafoy, 44, of Plano, Texas, was diagnosed with psoriasis in his
early 20s. He says it wasnt until about five years ago, when he went
on etanercept (Enbrel, Amgen) and got the condition under control,

AU G U ST 2014

that he realized how the disease was a burden on his everyday life.

16

I, like many others, pretty

flakes from his head.
much tried to hide my
My head was
condition so I didnt
completely covered with
have to explain myself,
psoriasis. I would go all day
he says.
and my scalp would itch so
Colleagues, friends
much and hurt so much. I
and friends would see the
would fight so hard not to
lesions or flakes from his
scratch because any little
Mr. Lafoy
head and say, Ew, whats
scratch would send snowyour problem? Or, Ew, what do
flakes of flakes down my shirt, he
you have?
says. As soon as I got home I would
It was always prefaced by Ew
lean over the bathroom sink and
As if it was some gross thing, Mr.
just scratch my scalp as long as I
Lafoy says. It brings you down.
could until I could get some kind of
Mr. Lafoy, a civil engineer, says he
level of comfort. I did that for years.
went for years without wearing darkI tried every topical medicacolored shirts that might showcase
tion. I tried peanut oil. Every-

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thing my dermatologist would

give me and got no relief. It wasnt
until I got on the biologics that I
pretty much cleared up almost
instantly, within literally a few
weeks. Then, I realized it was
like a 9,000-pound weight on my
shoulders, he says.

physical impact
Still, it wasnt the psychosocial
aspects of the disease that led Mr.
Lafoy to want a stronger medication it was the physical impact of
the disease. Mr. Lafoy, who is active
in sports, lost most of the use of his

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DermatologyTimes

psychosocial impact of psoriasis: thE statistics

More than half of the psoriasis patients surveyed by the National Psoriasis Foundation (NPF) said their
psoriasis was disfiguring. Seventy-three percent of the thousands of people who responded said they
felt angry or frustrated about their psoriasis. And 59 percent reported psoriasis was a large problem in
their everyday lives.
That was among the findings of phone and Internet surveys conducted by the NPF from spring
2004 through spring 2009. Of the 4,725 psoriasis sufferers responding, 75 percent had moderate-tosevere disease and 25 percent had mild disease. Females made up 59 percent of the total respondents, 73 percent of whom were over age 40.
Of the survey respondents, 87 percent were Caucasian, 4 percent Hispanic/Latino/mixed, 2 percent
African-American; 2 percent Asian-American and 1 percent Native American.

AMONG OTHER SURVE Y FINDINGS:

73 percent of respondents said they feel self-conscious about their psoriasis;
65 percent said that psoriasis makes their appearance unsightly;
72 percent of respondents suffer from itching, 70 percent from physical irritation,
and 59 percent from physical pain from psoriasis;
in addition to the 59 percent who said psoriasis was a large problem in their everyday lives,
17 percent admitted the disease is a very large problem in their everyday lives;
75 percent of minority respondents said psoriasis impacted their overall emotional well-being,
compared with 62 percent of caucasians;
minority respondents were also more likely than caucasian respondents to feel self-conscious,
embarrassed, angry or frustrated and helpless because of psoriasis;
among the general population of respondents, 74 percent of those ages 20 to 39 said psoriasis
had a large impact on their overall emotional well-being, compared with 59 percent of respondents
over age 40. DT

National Psoriasis Foundation 2014 www.psoriasis.org

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The medication his father took

(before biologics were available to
treat psoriasis) made Mr. Lafoys
dad lose 50 pounds, he says.
We (had) neighbors that
would actually come to me and
ask me if my father had AIDS,
Mr. Lafoy says.
While he says he has not
completely cleared since taking
the biologic, Mr. Lafoy feels more
confident and less worried about
his appearance. Mr. Lafoy says his
dermatologist had done a good job
in prescribing medications, but he
doesnt recall ever being asked by
his doctor whether he was bothered by his psoriasis.

There were never any discussions about how are you feeling?
Are you having problems at
work because of the flakes? Mr.
Lafoy says. I dont think I was
waiting for somebody to bring
it up. It wasnt until the last
few years that I realized, if we
dont start talking about this,
were not going to be able to help
other people in understanding
that this isnt just a skin disorder
or just arthritis. This is a lot
deeper and more involved.
His message to dermatologists:
Put yourselves in your patients
shoes and look at it from that
perspective. DT

ES472389_DTSupp0814_017.pgs 07.26.2014 01:15

AU G U ST 2014

right hand and right foot due to

psoriatic arthritis.
That was actually a bad condition because I was misdiagnosed,
he says. I didnt know the signs
of psoriatic arthritis, even though
Ive been around psoriasis my
entire life. My father had it.
Mr. Lafoy says he feared oral
medications because a chemotherapy-like drug almost killed his
father. For Mr. Lafoy, the psychosocial impact goes deeper than his own
experiences. As a youngster, he says
he would watch his dad come home
from work and take his socks off.
His feet would be so bad, his socks
would be full of blood, Mr. Lafoy says.

17

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Psoriasis unsPoken Pain

psoriasis

strEss
rEsponsE
IN VITRO
lisette hilton | senior staff Correspondent

AU G U ST 2014

R
18

ichard D. Granstein, M.D., chairman of

dermatology, Weill Cornell Medical College,
New York, has conducted research on how
the nervous system and,
perhaps, stress can make psoriasis worse or control the phenotypic expression of psoriasis.
Something which is often overlooked is that the expression of
psoriasis on humans depends on
innervation, Dr. Granstein says.
First, some background:
Dr. Granstein
Researchers discovered some 40
years ago that if the nerve supply to areas of skin
bearing psoriasis is interrupted either surgically

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or from an accident the psoriasis improves or goes

away in that area. About the same time, it was also
shown that local anesthetics injected into psoriatic
lesions will improve them or make them resolve.
Two more recent mouse models of psoriasiform
dermatitis offer clinical evidence suggesting the
important role nerves play in the pathogenesis of
psoriasis.
In these two mouse models, if you interrupt the
nerve supply to the area of mouse skin that has the
psoriasiform dermatitis, it gets better, Dr. Granstein says.
While its not completely clear how this comes
about, Dr. Granstein and colleagues have shown
that by treating Langerhans cells with the neuro-

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NPF PEER MENTORING

The National Psoriasis Foundation (NPF), www.psoriasis.org a nonprofit foundation offering

information, support, research, advocacy and more now has a peer mentoring program
that pairs psoriasis patients who are trained to mentor others with the disease with those who
are newly diagnosed or struggling with psoriasis. The program, called the Psoriasis One to
One peer mentor program, can be found at www.psoriasis.org or at http://www.psoriasis.org/
newly-diagnosed/one-to-one/mentors/find-a-mentor.
The NPF holds More than Skin Deep events and webcasts for patients with psoriasis to
educate consumers about the latest research, how to better control psoriasis and psoriatic
arthritis, manage stress and more (https://www.psoriasis.org/sslpage.aspx?pid=628)
Another good resource, according to clinical health psychologist Madelyn Petrow-Cohen, M.A.,
L.C.S.W., is Inspire.com, billed as a safe place where people can chat about different problems,
including psoriasis. Theres a group called Talk Psoriasis; the group is connected with the NPF and
can be found at https://www.inspire.com/search/?query=talk+psoriasis&submit.x=0&submit.y=0.
The Look Deeper campaign in the U.K. looks at the association between psoriasis and mental
health: http://www.seepsoriasislookdeeper.co.uk/
In June 2014, the NPF launched a new project to improve diagnosis, care and treatment for people
with psoriatic arthritis. The NPF Psoriatic Arthritis Project, at www.psoriasis.org/PsAProject, aims
to give healthcare providers new tools to better serve patients. Among the areas of focus: to
improve the understanding of psoriatic arthritis symptoms, disease management and impact on
patient quality of life among healthcare providers, according to an NPF news release. DT

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This may be relevant because IL-6 is also an

important factor in the differentiation of Th17
cells, Dr. Granstein says. So, to bring stress into
it, one might imagine that under conditions of
stress, the sympathetic nervous system is activated and then norepinephrine and ATP are
released by the sympathetic nervous system,
which innervates blood vessels in the skin and
also innervates lymphoid organs, such as lymph
nodes. Then, release of norepinephrine and
ATP may induce endothelial cells to release
more IL-6, which may then skew local immunity
towards the Th17/IL-17 and thereby make psoriasis worse. Its just a hypothesis, but I think its
interesting. DT

ES472780_DTSupp0814_019.pgs 07.26.2014 03:03

2014

peptides vasoactive intestinal polypeptide and pituitary adenylate cyclase-activating polypeptide and
allowing the Langerhans cells to present antigen
in vitro to responsive T cells, the result is skewed
towards the generation Th17-type helper T cells.
The reason this is relevant to psoriasis is it is
believed that Th17 cells and the interleukin (IL)-17
family of cytokines are important in the pathogenesis of psoriasis, he says.
Furthermore, the researchers have shown that
treating human endothelial cells with norepinephrine (a sympathetic nerve transmitter) and
adenosine-5-triphosphate (or ATP, also a sympathetic nerve transmitter) causes the cells to produce
the cytokine IL-6.

19

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IM TIRED OF BEING STARED AT.

BUT WORSE, I DONT EVEN WANT
TO SEE MYSELF.
Many patients with moderate to severe psoriasis
(PsO) have trouble expressing how theyre doing.
You probably have patients in your practice who still
suffer from embarrassment, poor self-image, and
social isolation but arent talking to you about it.1-4
But with just 1 revealing question, you can uncover
the dissatisfaction your patients may have trouble
expressing and help make a real difference in
managing their PsO.

MAKE A CONNECTION.
MAKE A DIFFERENCE.
Find out how you can help at PsOmuchmore.com

References: 1. Data on fle. Kantar Health 2013. Novartis Pharmaceuticals Corp; 2014. 2. Gupta MA, Gupta AK, Watteel GN. Perceived deprivation of social touch in
psoriasis is associated with greater psychologic morbidity: an index of the stigma experience in dermatologic disorders. Cutis. 1998;61(6):339-342. 3. Schmid-Ott G, Jaeger
B, Kuensebeck HW, Ott R, Lamprecht F. Dimensions of stigmatization in patients with psoriasis in a Questionnaire on Experience with Skin Complaints. Dermatology.
1996;193(4):304-310. 4. Armstrong AW, Schupp C, Wu J, Bebo B. Quality of life and work productivity impairment among psoriasis patients: fndings from the National
Psoriasis Foundation survey data 2003-2011. PLoS One. 2012;7(12):e52935.

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936-1080

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2014 Novartis

5/14

XDP-1304100

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