Final Clinical Study Report

Final Clinical Study Report
Pooled Study Results for Two Randomized, Double-Blind, Device Controlled

Clinical Trials Evaluating the Safety and Efficacy of the
Hairmax LaserComb 7, 9 & 12 Beam Models for the Treatment of
Androgenetic Alopecia in Males
Protocol:
HairMax 7 2009-M-01
&
HairMax 9.12 2009-M-02
Sponsor:
Lexington International, LLC
Statistical Analysis Prepared by:
Stat-Tech Services, LLC
October 29, 2010
1. Summary
These two double blind, device controlled 26 week clinical studies were conducted at four
research sites under GCP guidelines and were monitored by Palm Beach CRO. Further, IRB
clearance was obtained from Chesapeake IRB. The principal investigators for the studies were,
Zoe Draelos, M.D., David Goldberg, M.D., Abe Marcadis, M. D, and Michael Jarratt, M.D.. The
goal of the trials were to prove efficacy equivalency or improvement to the predicate HairMax
LaserComb which was cleared for marketing under FDA 510(k) numbers K060305 and
K093499. The trials were listed on www.clinicaltrials.gov, which is a registry of federally and
privately supported clinical trials conducted in the United States and around the world. Aside
from the specific HairMax LaserComb device, the two study protocols were identical in that they
had exactly the same design, inclusion criteria, visit schedule, assessments, and procedures.
Primary Conclusions
The results of the pooled analysis showed that the HairMax LaserComb 7, 9, 12 Beam devices
were safe and effective in the promotion of hair growth and in the cessation of hair loss in males
diagnosed with androgenetic alopecia when treatment is applied three times per week on nonconcurring days a week (i.e. Monday, Wednesday, Friday) for 26 weeks. All models of the
HairMax LaserComb demonstrated efficacy on their own and results from the individual models
were statistically comparable. The treatment effect on improved hair count (hairs/cm2) was
statistically significant by 16 weeks and maintained statistical significance for the duration of the
study. Safety analyses showed no safety concerns for the HairMax LaserComb 7, 9, 12 Beam in
these subjects.
1.1.
Study Objectives
The primary aim of the study was to assess the safety and effectiveness of the HairMax
LaserComb 7, 9 & 12 Beam Models in the promotion of hair growth and in the cessation of hair
loss in males diagnosed with androgenetic alopecia.
1.2.
Study Design
The analysis pooled results from two studies of the HairMax LaserComb for comparison against
a common control. Both studies were designed as multicenter, randomized, device-controlled
clinical trial conducted at four sites, three for protocol HM2009M01 and two for protocol
HM2009M02 in the United States (one center conducted clinical trials for both HM200901MO1
and HM2009M02). In the HM2009M01, study subjects who met all entry criteria were
randomized in a 2:1 fashion to receive either the HairMax LaserComb, 7 Beam Model or the
control device. In the HM2009M02 study, subjects who met all entry criteria were randomized
in a 1:1:1 fashion to receive either the HairMax LaserComb, 9 Beam Model, HairMax
LaserComb, 12 Beam Model or the control device. Randomization was stratified to balance
treatment assignments within investigational centers. Subjects were to use the device three times
per week on non-concurrent days for a total of 26 weeks. Terminal hair counts were measured at
baseline immediately prior to randomization and again at 16 and 26 weeks.
Confidential Property of Lexington International, LLC
Distribution prohibited without written permission
1.3.
Subject Population and Demographics
The study population included males between the ages of 25 and 60 years with a diagnosis of
androgenetic alopecia who had been experiencing active hair loss within the last 12 months.
They were also required to have a Norwood-Hamilton classification of IIa to V (for males), and
have Skin Type I, II, III, or IV on the Fitzpatrick Skin Type Scale. Skin types were limited to the
Fitzpatrick Skin types I-IV to facilitate the hair counting process, as it is difficult to count hairs
on darker skin tones. In the HM2009M01 study a total of 49 subjects were randomized across
two sites between September 1, 2009 and January 8, 2010. In the HM2009M02 study a total of
79 subjects were randomized across three sites between August 3, 2009 and December 11, 2009
(one site conducted both the HM2009M01 and HM2009M02 studies). Baseline demographics
and clinical characteristics show that subjects randomized to LaserComb 7 Beam, HairMax
LaserComb 9 Beam, LaserComb 12 Beam, and the control device had comparable baseline
characteristics
1.4.
Methods
Screened subjects who met the entry criteria continued on or returned to the study site for the
baseline visit. At this visit study personnel assessed the subjects scalp for any signs of irritation
or dermatological conditions that would disqualify the subject from study participation. Qualified
subjects had the target site area of the scalp identified, global digital images taken, a hair clipping
to expose the target area, the center of the target region tattooed, and macro images taken. They
were then randomized and provided with their study device. Subjects returned to the clinic at 8
and 16 weeks at which point global digital images were taken, hair clipping and re-tattooing
occurred if necessary. Macro imaging and hair count were assessed at the Week 16 visit.
Adverse events and concomitant medications were collected, vital signs were assessed, the scalp
was evaluated for local dermatitis and other scalp conditions, and subjects completed an multiquestion questionnaire at all visits. At the final visit, Week 26 or the termination visit, the same
procedures as Week 16 visit were performed with the addition of the investigator global
assessment of new hair growth.
1.5.
Results
Subjects in the HairMax LaserComb 7, 9, 12 Beam device group had a significantly greater
increase (p<0.0001) in mean terminal hair count than subjects receiving the control device. The
mean change in terminal hair count was 20.4 hairs/cm for HairMax LaserComb 7, 9, 12 Beam
group and 3.8 hairs/cm for the control device group at Week 16. At 26 weeks the mean terminal
hair count was 21.6 hairs/cm for the HairMax LaserComb 7,9,12 Beam device group and 6.4
hairs/cm for the control device group. (See Appendix Table 1 for non-pooled results)
Table 1 summarizes the principle results of effectiveness. Comparison of the combined HairMax
LaserComb 7, 9, 12 Beam to the control device responses revealed highly significant differences
in categorical hair counts for both groups at both time points (p0.0001) in each case. (Nonpooled data for the HairMax, 7,9,12 devices can be found in Appendix, Table 1)
Mean differences between the HairMax LaserComb 7, 9, 12 Beam device group and the control
device were greater than15 hairs/cm2, and these results were maintained at the Week 26 visit.
The changes were dramatic in that changes in hair count of >=10 hairs/cm2, was seen in 47 or
70.1% of HairMax LaserComb 7, 9, 12 Beam device subjects, but in only 5 (14.7%) control
device subjects (outliers excluded).
Few adverse events were reported and adverse events were generally similar across the treatment
arms. No HairMax LaserComb subject experienced a severe adverse event.
Table 1
Terminal Hair Count Change from Baseline Summary Last Observation Carried Forward
Efficacy Subjects
Summary
Number of Subjects
Week 16
N
Mean (SD)
Median
Min, Max
P-value1
Week 26
N
Mean (SD)
Median
Min, Max
P-value1
Treatment
HairMax
LaserComb 7,
9, 12 Beam
Control
67
36
67
20.4 (15.05)
19.1
-16.6, 57.3
<.0001
36
3.8 (7.77)
3.8
-15.3, 31.8
67
21.6 (15.06)
20.4
-5.1, 57.3
<.0001
36
6.4 (11.95)
5.1
-16.6, 53.5
Treatment difference test obtained from ANCOVA controlling for age, skin type, and study site.
2. Description of Subjects
Subjects were enrolled between August 25, 2009 and January 8, 2010 for the HM2009M01. For
the HM2009M02 study were enrolled between July 29, 2009 and December 11, 2009 and,
according to the following inclusion/exclusion criteria:
2.1.
Inclusion Criteria
Prospective subject is male with a diagnosis of androgenetic alopecia according to the

Guidelines of the American Dermatological Association; subject must have presence of
miniaturized hair in the target area.

Prospective subject must have been experiencing active hair loss, within the last 12
months.
Prospective subject must be in good general health.
Prospective subject must have a Norwood-Hamilton classification of IIa to V.
Prospective subject must have Skin Type I, II, III, or IV on the Fitzpatrick Skin Type
Scale.
Prospective subject must be between 25 and 60 years of age at the time of enrollment.
Prospective subject must be willing to have a dot tattoo placed on the target area of the
scalp and re-applied, if necessary.
Prospective subject must be willing to maintain normal shampooing habits and use of
hair care products during the study.
Prospective subject must be willing to maintain the same hairstyle, approximate hair
length and hair color throughout the study. If hair is colored at the time of enrollment,
prospective subject must be willing to continue the same color and product line, not
coloring hair within 7 days prior to a visit.
Prospective subject is willing to continue his current regimen of vitamins and nutritional
supplements and not start any new vitamins or nutritional supplements for the duration of
the study.
Prospective subject must be able to read and understand English, and provide written
(signed) informed consent after the nature of the study has been fully explained and
before any procedures dictated by this protocol are performed.
Prospective subjects must be willing and able to comply with follow-up requirements,
including adhering to scheduled office visits in a timely manner.
If hair count range is 20% outside ideal range (ideal hair counts in the target zone will be
between 90-150 hairs per cm2); or if there are no miniaturized hairs, the subjects will be
excused by the investigator. These subjects will be considered a screen failure, not intent
to treat. Screen failures will be documented in the study record, with the reason they were
screened out of the trial. The information gleaned from screening failures may be of
value to further development of self-selection labeling information.

2.2.
Exclusion Criteria
Prospective subject has an active malignancy of any type or history of any malignancy
including any malignancy in the treatment area in the past five years (subjects who have
had a history of basal cell carcinoma that has been treated in areas other than the
treatment area are acceptable).
Prospective subject has a history of hypogonadism.
Prospective subject has used phytotherapy (e.g., saw palmetto) within eight weeks prior
to baseline.
Prospective subject has any active skin infection in the scalp area or scarring in the target
area.
Prospective subject has photosensitivity to laser light.
Prospective subject has used Accutane in the previous year.
Prospective subject has a history of poor wound healing.
Prospective subject has a history of keloid formation.
Prospective subject has known history of anticoagulant use (other than aspirin [<325 mg.,
QD, which is stable for three months]).
Prospective subject has used or currently takes any of the following medications during
the six months prior to screening: minoxidil, finasteride (or any other 5reductase
inhibitor medications), medications with anti-androgenic properties (e.g., cyproterone
acetate, spironolactone, ketoconazole, flutamide, bicalutamide), topical estrogen,
progesterone, tamoxifen, anabolic steroids, medications which can potentially cause
hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin, psoralens), oral glucocorticoids
(inhaled glucocorticoids are permitted), lithium, phenothiazines, or other medications at
the discretion of the Investigator.
Prospective subject has a history of thyroid or other medical condition that might
influence hair growth and loss, at the discretion of the Investigator.
Prospective subject has "buzz" cut hairstyle, defined as hair cut to less than 1/2 inch in
length.
Prospective subject has light blonde hair, at the discretion of the Investigator.
Prospective subject has chronic dermatological condition (eczema, psoriasis, infection,

etc.) of the scalp other than male pattern hair loss.
Prospective subject has a pacemaker, defibrillator or other active implantable device.
Prospective subject has had hair transplants, scalp reduction, current hair weave, or
tattooing in the target area, which makes it difficult to perform hair count assessments.
Prospective subject has ever received radiation therapy to the scalp, or has had
chemotherapy within the past year.
Prospective subject has a known underlying medical problem that could adversely affect
hair growth such as HIV infection, connective tissue disease, and inflammatory bowel
disease, or other medical conditions, at the discretion of the Investigator.
Prospective subject has participated in any investigational study within the 30 days prior
to enrollment.
Prospective subject has a history or evidence of drug and/or alcohol abuse within the 12
months prior to enrollment which has not been satisfactorily mitigated.
Prospective subject has a history or the presence of any serious and/or chronic medical
condition(s) [including psychiatric illnesses] which, in the opinion of the investigator,
may cause harm to the individual and/or compromise/confound the study results
3. Study Procedures
3.1.
Visit 1 Screening (Day-14)
Potential subjects read and signed informed consent and HIPPA documents. Following the
consent process, demographic and background information was collected, including age, gender,
ethnic origin and significant medical history. Additionally, all medications, including over-thecounter drugs, taken within 6 months prior to the start of the study were recorded. Qualified
study personnel took vital signs (blood pressure and pulse). The investigator assessed scalp
condition including evaluation of Fitzpatrick Skin Type, and recorded hair-thinning pattern using
the Norwood-Hamilton scale. (Fitzpatrick Skin Type and Norwood-Hamilton procedures could
have been performed at Screening or Baseline.) Male subjects exhibiting Types IIa to V on the
Norwood-Hamilton scale qualified for the study. It was determined that subjects had
miniaturized hairs in the target area for adequate determination of active hair loss. An evaluation
was also conducted and recorded to determine that subjects did not exhibit signs of skin/scalp
conditions that preclude participation in the study. If time allowed, the subject continued
immediately to Visit 2/Baseline/Day 0.
3.2.
Visit 2 Baseline (Day 0)
Subjects continued the remainder of the screening process, including the Fitzpatrick Skin Type
and Norwood-Hamilton Classification, if not done at the screening visit . Or, if necessary for
scheduling, they may have returned to the study site within 30 days for the final baseline
enrollment (Day Zero) and imaging studies. However, if after 30 days, subjects must have signed
a new informed consent form. Subjects were questioned concerning changes in health status and
changes in or additions to concomitant medications since Visit 1, if they returned to the clinic for
completion of the enrollment.
Qualified study personnel took vital signs and assessed the subjects scalp for any signs of
irritation or dermatological conditions that would disqualify the subject from study participation.
The following procedures were completed in successive order. Details for these steps are
provided below:
target site area identification
global digital images(must be taken prior to the hair clipping/tattooing)
hair clipping
tattooing
macro imaging (final determination if subject may be enrolled)
randomization
blinded disbursement of test product or control product, instructions for use, and
questionnaire for subject static self-global assessments of hair regrowth.
diary dispensing and instructions.
3.2.1. Target Site Area Identification

Each target site to be studied was chosen by the clinical investigator based on the appearance of
miniaturized hairs which are the hallmark of androgenetic alopecia. Evaluations of vellus hair
counts were conducted by trained personnel skilled in identifying and defining vellus hair. A
circle, approximately 1 inch in diameter, positioned in the vertex or frontal portion of the scalp,
was identified as the site for hair clipping. Within this site was the target area for the Hair Count
Evaluation. The target area was located in the transition portion of the subjects scalp and had the
presence of some miniaturized hairs. Ideal hair counts in the target zone were between 90-150
hairs per cm2.
3.2.2. Global digital images
For global images (must be taken prior to the hair clipping/tattooing), the subject sat in a chair
and was properly positioned. The digital images were standardized for lighting, camera angle,
and position of subjects head in each digital image to achieve similar camera angle and relative
image size. Global images were taken using a digital camera. Global digital images were taken to
document any evidence of initial hair reverse miniaturization and re-growth. All imaging was
conducted in the same order and with the same methods as at the baseline. Any retakes must
have been made prior to the subject leaving the clinic, so all efforts were made to ensure the
photographs were acceptable.
3.2.3. Hair Clipping

A template was provided to the investigator for identifying the size of the area for hair clipping.
3.2.4. Tattooing
Once the hair was clipped, trained study personnel used a professional tattooing machine to
apply a permanent ink dot, approximately the size of a period (.) in the center of the circle. The
tattoo was used as a guide for placing the template on the scalp surface at subsequent visits for
the hair clipping and macro images for hair count evaluation. The tattoo may have been reapplied
at subsequent follow-up visits, if required.
3.2.5. Macro Images, Final Screening and Enrollment
Baseline macro images were evaluated for hair counts range and to confirm inclusion of
miniaturized hairs. The Canfield Epilume System was used for digital imaging. A reticule was
placed on the lenses for precise and consistent alignment on the tattoo. The reticule was
approximately a 7 cm2 area circle with a diameter of 2.96 cm. A 10 mm scale divided in 0.1 mm
increments was etched into the reticule for calibration purposes during the hair count evaluations.
The images were recorded on compact flash cards. During the baseline visit, and subsequent
visits, the images may have been previewed to see if the image quality was acceptable. If images
were unacceptable they were retaken immediately. Images may not be repeated if the subject has
left the office for that visit day, so all efforts to confirm image quality must have been made
immediately. Retakes were identified in the study record. After the subjects visit was complete,
the images were uploaded to a designated site for image archiving and independent assessment.
3.2.6. Randomization
Subjects were randomized into either the HairMax LaserComb 9, HairMax LaserComb 12 or
control device group in the HM2009M02 study in a 1:1:1 ratio, or into either the HairMax
LaserComb 7 or control device group in a 2:1 ratio in the HM2009M01 study. A statistician
provided each center with a randomization scheme such that the subject and the investigator did
not know the assignment of the subject to their group. Only the study monitor was able to audit
randomizations and only then after subjects had completed the study.
3.2.7. Product Dispensation
Test Product or control product were dispensed in a blinded manner including the instructions for
use, and questionnaire. Subjects were provided the device (depending upon their randomization)
and the IFU and asked to read the instructions.
For consistency and safety, a qualified clinical staff member instructed each subject on the
different components of the HairMax LaserComb, how to operate the device and the treatment
technique. This was performed by reviewing the instructions for use and performing a hands-on

10
demonstration using a dummy device that did not emit any light, to assure that the blinding
was not jeopardized.
3.2.8. Diary Dispensation and Instructions
Training also included a review of the how to record data into the diary logs and the instructions
on how and when to complete them.
3.3.
Visit 3 (Week 8) and Visit 4 (Week 16)
Subjects returned to the study site and were questioned concerning potential adverse events and
changes in or additions to concomitant medications since the last visit. Continuance criteria was
reviewed. Diaries were collected and reviewed. Qualified study personnel took vital signs and
evaluated the scalp of each subject for local dermatitis and other concurrent scalp conditions.
The following steps were conducted in the following order using the same procedures as in the
baseline:
global digital images (must be taken prior to the hair clipping/tattooing).
hair clipping and re-tattooing if necessary
macro imaging for hair counts at Visit 4 (no hair counts were done at sites macro data
collected and entered into EDC)
questionnaire for subjects static assessments of hair regrowth
dermatological scalp assessment at Visit 4

3.4.
Phone Follow Up Visit (Week 21) (7 days)
Safety assessment for adverse events
Reminded subject to return diary, questionnaire and LaserComb device at Visit 5
All subjective information recorded in EDC

3.5.
Visit 5 (Week 26) or Early Termination LOCF
Subjects returned to the study site and were questioned concerning potential adverse events and
changes in or additions to concomitant medications since the last visit. Diaries were collected
and reviewed. Qualified study personnel took vital signs and evaluated the scalp of each subject
for local dermatitis. The following steps were conducted in the following order using the same
procedures as in the baseline:
global digital images

11
macro imaging uploaded to EDC and hair count
questionnaire and dairies collected
dermatological scalp assessment
4. Pre-Specified Study Endpoints

4.1.
Primary Effectiveness Endpoint
The primary efficacy endpoint is the change in terminal hair count at 16 and 26 weeks compared
to baseline for each subject for both the treatment and control arms.
4.2.
Secondary Effectiveness Endpoint
Secondary effectiveness endpoints include the following measures:
Categorical change from baseline in terminal hair count.
Any improvement from baseline in terminal hair count (change > 0).
4.3.
Tertiary Endpoints
Tertiary effectiveness endpoints include the following measures:
Subject static self-global assessments of hair regrowth at each follow-up visit (without
referring to any images taken).
Investigators global assessment of hair regrowth at the last visit.

4.4.
Safety Endpoints
Safety endpoints included the monitoring of vital signs and all adverse events.
5. Description of Statistical Methods

5.1.
Sample Size Calculations
The two studies were individually powered based on similar assumptions to approximately 80%
power allowing for a 10% drop-out. Based on a prior study, the standard deviation (SD) of
change from baseline in terminal hair count was 18.6 hairs per square centimeter and a mean
difference in hair counts of 30 hairs/cm2. Both studies rounded the SD to 20 and assumed
smaller treatment difference near 20 hairs/cm2. The HM2009M01 study was randomized in a
2:1 allocation (HairMax LaserComb 7 Beam:Control device) and had a planned enrollment of 50
subjects. The HM2009M02 study was randomized in a 1:1:1 allocation (HairMax LaserComb 9
and HairMax LaserComb 12 Beam:Control device) and had a planned enrollment of 83 subjects .
12
5.2.
Baseline Comparisons
Statistical comparisons were made between treatment groups for all baseline demographic
variables. Continuous variables were compared with a one-way analysis of variance and
categorical variables by Fishers Exact test.
5.3.
Populations
The primary efficacy analysis was performed on all randomized subjects who had a baseline and
post-baseline terminal hair count, known as the modified intent-to-treat population (mITT). In
addition, a last observation carried forward (LOCF) analysis was performed for mITT subjects,
where missing values were replaced with the last observed value for subjects who terminated
prematurely. All randomized subjects who used the HairMax LaserComb or the control device
at least once were included in all safety analyses and this was referred to as the Safety
population. All randomized subjects were shown on an intent-to-treat basis for accountability
and in a sensitivity analysis and this was the ITT analysis.
5.4.
Primary Effectiveness Analysis
The primary analysis of effectiveness was an analysis of covariance, which separately modeled
terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax
LaserComb 7,9,12 Beam vs. pooled control device), study center (unique within study), age (as a
continuous variable), and Fitzpatrick Skin Type Classification (as a categorical variable with
four levels). The active group (HairMax LaserComb 7,9,12 Beam) was compared to the control
device using least squares means with a two-sided test at the 5% level of significance. Overall
study differences were controlled through the inclusion of study site, however, overall
differences across the studies were estimated by contrasting the difference in the average of
study sites in HM2009M01 and HM2009M02.
Several additional analyses were also performed to assess the sensitivity of the primary efficacy
results. An LOCF analysis was performed on the efficacy subjects, and a second analysis also
using the randomized subjects missing values equal to zero.
In order to individually compare the HairMax LaserComb devices to the control device, the
primary efficacy analysis was repeated, separately modeling terminal hair count at Week 16 and
Week 26 as a function of individual treatment group (HairMax LaserComb 7, HairMax
LaserComb 9, HairMax LaserComb 12, and the pooled control device), study center, age, and
Fitzpatrick Skin Type Classification. The active groups (HairMax LaserComb 7, HairMax
LaserComb 9, and HairMax LaserComb 12) were individually compared to the pooled control
device using least squares means with a two-sided test of the 5% level of significance. A
contrast was used to test the null hypothesis that change from baseline results were homogeneous
across the HairMax LaserComb devices. The same analyses were completed using LOCF on
efficacy subjects.

13
5.5.
Secondary Effectiveness Analysis
5.5.1. Categorical Change from Baseline in Terminal Hair Count

Observed subject terminal hair count was analyzed using a Cochran-Mantel-Haenszel (CMH)
row-mean score test to assess differences in the treatment groups (HairMax LaserComb 7, 9, 12
Beam vs. pooled control device) for the ordinal response categories using efficacy subjects.
Uniform scores were assigned to the ordered categories, and results are provided for the Week 16
and Week 26 visit. In addition, an LOCF analysis is provided for efficacy subjects. The analysis
was stratified by study site.
5.5.2. Improvement from Baseline in Terminal Hair Count
Observed subject terminal hair count improvement (>0 hair count increase) was analyzed using a
CMH test stratified by study site to assess differences in treatment group (HairMax LaserComb
7, 9, 12 Beam vs. pooled control device) for the dichotomous response using efficacy subjects.
Results are provided for the Week 16 and Week 26 visit. In addition, an LOCF analysis is
provided for efficacy subjects.
5.5.3. Change in Terminal Hair Count from Baseline by Covariates
Observed subject terminal hair count change from baseline by covariate was analyzed using an
analysis of variance to assess differences in treatment group (HairMax LaserComb 7, 9, 12 Beam
vs. pooled control device) and covariates using efficacy subjects. Change from baseline in
terminal hair count was modeled as a function of baseline hair count, treatment group, covariate
(study center, skin type, or age group), and the interaction of the treatment group and covariate.
Results are provided for the Week 16 and Week 26 visit. F-statistics for the ANCOVA are
provided and mean (SD) results summarized by level of the covariate.
5.6.
Tertiary Endpoints Analysis
5.6.1. Subject and Investigator Questionnaires

Observed investigator global hair growth assessments and subject questionnaire results (tertiary
analyses) were analyzed using a Cochran-Mantel-Haenszel row-mean score test to assess
differences in the treatment group (HairMax LaserComb 7, 9, 12 Beam vs. pooled control
device) stratified by center for each of the ordinal responses on efficacy subjects. Uniform
scores were assigned to the ordered categories, and results are provided by visit. Subjects
terminating early had their last observed value carried forward for an LOCF analysis of the last
visit for the efficacy subjects for the subject questionnaire results.

14
5.6.2. Perceived Treatment Group

Subject responses as to their perceived treatment group were compared to their actual treatment
group using a kappa statistic. The kappa statistic measures the amount of agreement between the
actual treatment assignment and perceived treatment assignment that is due to chance alone.
This statistic is of the form (I0 - Ie)/(1-Ie), where I0 is the observed agreement (proportion of
subjects who were correct) and Ie is the expected agreement (proportion of subjects
demonstrating agreement under complete independence). A 95% CI is provided for this statistic.
5.7 Analysis of Safety
Adverse events are summarized as the number and percentage of subjects reporting each event
within a treatment group (HairMax LaserComb 7, 9, 12 Beam vs. pooled control device).
Comparisons between the HairMax LaserComb devices and the control device were made using
a Fishers Exact Test. Device-related adverse events are reported as a separate summary.
Adverse events are also summarized by severity and action taken to treat them.
Comparisons among the individual HairMax LaserComb devices and the pooled control device
were made using a Fishers Exact Test to assess homogeneity among the groups
6. Results
6.1 Subject Accounting:
A total of 146 subjects were screened between July 29, 2009 and January 8, 2010 between both
studies and a total of four study sites. Of these 146 subjects, 18 were not randomized and
therefore are not included in the tables below. This resulted in 128 randomized subjects. Of
these subjects, 9 did not receive any available follow-up or did not receive treatment with a study
device (7 HairMax LaserComb 7, 9, 12 Beam subjects and 2 control device subjects) resulting in
119 subjects in the Safety population. Reasons for drop out were primarily being lost-to-followup, though 5 HairMax LaserComb 7, 9, 12 Beam subjects withdrew consent and two did not
meet continuation criteria. Of the 119 safety subjects, 103 completed the 16 week follow-up
visit and were included as efficacy subjects.
Table 2 shows the study enrollment by population, study and site. For the pooled analysis, no
study site comprised more than 32.0% of the efficacy population subjects. The treatment arms
were balanced across each of the sites indicating the randomization procedure performed well.

15
Table 2
Study Enrollment By Population and Study Site
Treatment
Summary
Screened Subjects [1]
Study HM2009M01 Sites
01
02
01
02
03
Efficacy Subjects [2]
01
02
01
02
03
Safety Subjects [3]
01
02
01
02
03
HairMax
LaserComb
7, 9, 12 Beam
86
33
23
10
53
13
12
28
67
24
18
6
43
12
10
21
79
31
23
8
48
13
10
25
Control
42
16
11
5
26
7
5
14
36
14
9
5
22
6
4
12
40
15
10
5
25
7
4
14
Table 3 summarizes the demographic characteristics of subjects by treatment group. No

significant differences were noted for any of the demographic characteristics.

16
Table 3.
Demographics
Efficacy Subjects
Treatment
HairMax LaserComb
7, 9, 12 Beam
Control
67
36
Summary
Number of Subjects
Age
N
67
36
Mean (SD)
47.1 (9.21)
43.9 (10.26)
Median
50.0
45.5
Min, Max
26.0, 59.0
25.0, 61.0
Race
Caucasian
65 (97.0%)
34 (94.4%)
African American
0
0
Native American
0
0
Alaska Native
0
0
Asia/Pacific Islander
0
1 (2.8%)
Other
2 (3.0%)
1 (2.8%)
Total
67
36
Ethnicity
Hispanic or Latino
8 (11.9%)
3 (8.3%)
Not Hispanic or Latino
59 (88.1%)
33 (91.7%)
Total
67
36
Norwood-Hamilton
Classification
0
1 (2.8%)
II
29 (44.6%)
15 (41.7%)
III
25 (38.5%)
12 (33.3%)
IV
11 (16.9%)
8 (22.2%)
V
65
36
Total
Fitzpatrick Skin Type
Classification
6 (9.0%)
2 (5.6%)
I
20 (29.9%)
12 (33.3%)
II
29 (43.3%)
14 (38.9%)
III
12 (17.9%)
8 (22.2%)
IV
67
36
Total
1
ANOVA for age and Fishers Exact for categorical variables.
P-value1
0.1092
0.5341
0.7432
0.5364
0.8894
Table 4 summarizes medical history by body system. Subjects in the two treatment groups had
comparable medical history. No significant differences were noted between the treatment groups
and no specific type of history was observed

17
Table 4
Medical History
Efficacy Subjects
Summary
Number of Subjects
Medical System History
HEENT
Cardiovascular
Respiratory
Gastrointestinal
Renal/Urinary
Hepatic
Genitourinary
Endocrine
Hematologic
Lymphatic
Neurologic
Psychiatric
Immunologic
Dermatologic
Musculoskeletal
Surgical/medical
Other
1
Treatment
HairMax
LaserComb 7, 9,
12 Beam
Control
67
36
15 (22.4%)
14 (20.9%)
0
16 (23.9%)
3 (4.5%)
1 (1.5%)
0
1 (1.5%)
1 (1.5%)
1 (1.5%)
5 (7.5%)
3 (4.5%)
3 (4.5%)
6 (9.0%)
17 (25.4%)
14 (20.9%)
31 (46.3%)
7 (19.4%)
5 (13.9%)
2 (5.6%)
7 (19.4%)
0
1 (2.8%)
0
0
0
0
7 (19.4%)
5 (13.9%)
0
4 (11.1%)
10 (27.8%)
8 (22.2%)
10 (27.8%)
Fishers Exact test.

P-value1
0.8051
0.4367
0.1199
0.8045
0.5499
1.0000
NA
1.0000
1.0000
1.0000
0.1054
0.1240
0.5499
0.7368
0.8172
1.0000
0.0914
18
6.2. Primary Effectiveness Analysis
Table 5 shows summary statistics for the observed terminal hair counts by visit and the
difference in hair count is summed up in Table 6. Treatment differences were highly
statistically significant.
This statistical difference was reached in each of the primary efficacy analyses at less
than the 0.0001 level at Week 16 and Week 26. The estimated treatment difference at 16
weeks was 16.6 hairs/cm for the HairMax LaserComb 7,9,12 Beam compared to the
control device. Results were maintained through 26 weeks, with the estimated treatment
differences at 26 weeks of 13.7 hairs/cm (p=<0.0001) for HairMax LaserComb 7,9,12
compared to the control device.
Table 5
Observed Terminal Hair Count Summary
Efficacy Subjects
Summary
Number of Subjects
Baseline
N
Mean (SD)
Median
Min, Max
Week 16
N
Mean (SD)
Median
Min, Max
Week 26
N
Mean (SD)
Median
Min, Max
Treatment
HairMax LaserComb 7,
9, 12 Beam
Control
67
36
67
176.7 (61.27)
175.7
61.1, 308.1
36
189.0 (57.28)
194.8
36.9, 277.6
67
197.1 (64.42)
194.8
62.4, 352.7
36
192.8 (58.58)
198.6
33.1, 283.9
64
198.7 (64.64)
193.5
67.5, 351.4
35
197.3 (57.93)
202.4
38.2, 285.2

19
Table 6
Observed Terminal Hair Count Change from Baseline Summary
Efficacy Subjects
Summary
Number of Subjects
Week 16
N
Mean (SD)
Median
Min, Max
P-value 1
Week 26
N
Mean (SD)
Median
Min, Max
P-value1
1
Treatment
HairMax LaserComb
7, 9, 12 Beam
Control
67
36
67
20.4 (15.05)
19.1
-16.6, 57.3
<.0001
36
3.8 (7.77)
3.8
-15.3, 31.8
64
20.1 (13.66)
19.1
-5.1, 57.3
<.0001
35
6.4 (12.12)
5.1
-16.6, 53.5
Treatment difference test obtained from ANCOVA controlling for age, skin type, and study
Table 7 uses the last observed value carried forward for efficacy subjects with missing data,
and the changes in Terminal Hair Count Change from Baseline are shown in Table 8. The
LOCF analysis results were consistent with those seen in the analysis of the observed results
and confirmed the observed data analysis. The differences in least square means between
HairMax LaserComb 7, 9, 12 Beam compared to the control device are statistically
significant at both Week 16 and Week 26. (See Appendix Table 1 for non-pooled data)

20
Table 7
Terminal Hair Count Summary Last Observation Carried Forward
Efficacy Subjects
Summary
Number of Subjects
Baseline
N
Mean (SD)
Median
Min, Max
Week 16
N
Mean (SD)
Median
Min, Max
Week 26
N
Mean (SD)
Median
Min, Max
Treatment
HairMax LaserComb
7, 9, 12 Beam
Control
67
36
67
176.7 (61.27)
175.7
61.1, 308.1
36
189.0 (57.28)
194.8
36.9, 277.6
67
197.1 (64.42)
194.8
62.4, 352.7
36
192.8 (58.58)
198.6
33.1, 283.9
67
198.3 (64.21)
193.5
67.5, 351.4
36
195.4 (58.28)
201.8
38.2, 285.2

21
Table 8
Terminal Hair Count Change from Baseline Summary Last Observation Carried Forward
Efficacy Subjects
Treatment
Summary
Number of Subjects
Week 16
N
Mean (SD)
Median
Min, Max
P-value1
Week 26
N
Mean (SD)
Median
Min, Max
P-value1
1
HairMax
LaserComb 7, 9,
12 Beam
67
Control
36
67
20.4 (15.05)
19.1
-16.6, 57.3
<.0001
36
3.8 (7.77)
3.8
-15.3, 31.8
67
21.6 (15.06)
20.4
-5.1, 57.3
<.0001
36
6.4 (11.95)
5.1
-16.6, 53.5

22
6.2.3. Categorical Change from Baseline in Terminal Hair Count

Table 9 summarizes the individual subject results in 6 categories to demonstrate the individual subject
changes from baseline in hair counts.
LOCF results at 16 weeks are quite dramatic in terms of subjects with >20 increases with 47.8% of
HairMax LaserComb 7, 9, 12 Beam subjects achieving the result and only 2.8% of control device
subjects achieving the result. The advantage was also present in the >5 to 20 point category, in that
subjects obtained a >5 increase in 88.1% of HairMax LaserComb 7, 9, 12 Beam subjects and only
47.2% of control device subjects. A similar trend existed for the Week 26 results.
Results help demonstrate that the HairMax LaserComb 7, 9, 12 Beam clearly outperformed the control
device group with subjects having >20 increases in terminal hair count.
Table 9
Terminal Hair Count Categorical Change from Baseline for Last Observation Carried Forward
Efficacy Subjects
Summary
Number of Subjects
Week 16
-20
>-20 to -5
>-5 to 0
>0 to 5
>5 to 20
>20
Total
P-value1
Week 26
-20
>-20 to -5
>-5 to 0
>0 to 5
>5 to 20
>20
Total
P-value1
1
Treatment
HairMax LaserComb
7, 9, 12 Beam
Control
67
36
0
2 (3.0%)
3 (4.5%)
3 (4.5%)
27 (40.3%)
32 (47.8%)
67
<.0001
0
3 (8.3%)
9 (25.0%)
7 (19.4%)
16 (44.4%)
1 (2.8%)
36
0
1 (1.5%)
2 (3.0%)
8 (11.9%)
22 (32.8%)
34 (50.7%)
67
<.000
0
3 (8.3%)
8 (22.2%)
6 (16.7%)
16 (44.4%)
3 (8.3%)
36
Cochran-Mantel-Haenszel row-mean score test with integer scores stratified by study site

23
The two subjects in the control group with the greatest increase in hair count (Subject 01-002
with + 31 hairs/cm and 03-026 with 42 hairs/cm at 26 weeks) appeared to be outliers in the
statistical analysis. The standard deviation from the analysis of variance for the control group at
26 weeks was 11.95 hairs/cm and these subjects had 37 hairs/cm (subject 01-002) and 19.1
hairs/cm (subject 03026) respectively. To assess the impact of these subjects on the analysis,
they were removed, and the LOCF results are shown in Table 10. Removal of these subjects
reduced the standard deviation from 11.95 hairs/cm to 7.88 hairs/cm, however, the impact on
the final results was negligible.
Table 10
Terminal Hair Count Change from Baseline Summary Excluding
Outliers Last Observation Carried Forward
Efficacy Subjects
Treatment
Summary
Number of Subjects
Week 16
N
Mean (SD)
Median
Min, Max
P-value [1]
Week 26
N
Mean (SD)
Median
Min, Max
P-value [1]
HairMax LaserComb
7, 9, 12 Beam
67
Control
34
67
20.4 (15.05)
19.1
-16.6, 57.3
<.0001
34
2.8 (6.23)
3.8
-15.3, 15.3
67
21.6 (15.06)
20.4
-5.1, 57.3
<.0001
34
4.3 (7.88)
4.5
-16.6, 24.2
An additional sensitivity analysis was performed based on randomized subjects that substituted 0
scores for subjects with no terminal hair count information. Table 11 below shows the results.
While the analysis is based on a very conservative assumption of no response in subjects who
were not available for analysis, the results maintained a high level of statistical significance at
the Week 16 visit with p<0.0001 even with 19 non-efficacy subjects in the HairMax LaserComb
7, 9, 12 Beam device group. This result occurred despite only having 6 non-efficacy subjects in
the control device group. Results were maintained through Week 26 (p = 0.0002).

24
Table 11
Terminal Hair Count Change from Baseline Summary Missing Values Imputed to Zero
Randomized Subjects
Treatment
Summary
Number of Subjects
Week 16
N
Mean (SD)
Median
Min, Max
P-value1
Week 26
N
Mean (SD)
Median
Min, Max
P-value1
1
HairMax
LaserComb 7, 9,
12 Beam
86
Control
42
86
15.9 (15.76)
14.0
-16.6, 57.3
<.0001
42
3.2 (7.30)
2.5
-15.3, 31.8
86
14.9 (14.70)
12.7
-5.1, 57.3
0.0002
42
5.3 (11.30)
2.5
-16.6, 53.5
In summary, robust and consistent effects were observed in the HairMax LaserComb 7, 9, 12
Beam devices compared to the control device, as well as the individual HairMax LaserComb
devices compared to the control device. HairMax LaserComb effects observed at 16 weeks were
maintained to the end of the study in all HairMax LaserComb arms. An LOCF analysis on the
efficacy subjects indicated no problems with missing data in the combined HairMax LaserComb
devices, or in the individual HairMax LaserComb device comparisons to the control device. A 0
score imputation for subjects with missing hair counts based on randomized subjects was
statistically significant in the HairMax LaserComb 7, 9, 12 Beam (p<0.0001) at 16 weeks, and
these results were maintained through Week 26 (p = 0.0002). Strong, statistically significant
treatment effects were observed.
6.2.4. Change in Terminal Hair Count from Baseline by Covariates
Tables 12, 13, 14 display the summaries of change in terminal hair count by covariate and the
analysis of terminal hair count as a function of the covariate (skin type, age, or study center),
treatment, the interaction of treatment and the covariate, and baseline hair count.

25
There were no statistically significant study center and treatment interaction Table 12
Table 12
Observed Terminal Hair Count Change from Baseline by Study Center and Treatment
Efficacy Subjects
HairMax LaserComb 7, 9, 12 Beam
Visit
Week 16
Week 26
Week 26 LOCF
Study Center
M01-01
M01-02
M02-01
M02-02
M02-03
M01-01
M01-02
M02-01
M02-02
M02-03
M01-01
M01-02
M02-01
M02-02
M02-03
N
18
6
12
10
21
18
6
11
9
20
18
6
12
10
21
Control

Mean (SD)
Med.
Min, Max
19.6 (13.57)
19.7
-17, 50
11.9 (8.81)
12.7
-3, 23
26.5 (16.63)
20.4
9, 57
24.8 (15.10)
26.7
1, 52
18.0 (16.00)
19.1
-5, 56
21.7 (13.67)
19.7
1, 48
8.5 (8.99)
11.5
-5, 17
24.4 (14.89)
22.9
4, 57
28.0 (12.78)
33.1
6, 39
16.1 (11.95)
16.6
-4, 38
21.7 (13.67)
19.7
1, 48
8.5 (8.99)
11.5
-5, 17
26.7 (16.31)
22.9
4, 57
30.4 (14.27)
35.0
6, 52
18.0 (14.54)
17.8
-4, 56
N
9
5
6
4
12
9
5
5
4
12
9
5
6
4
12
Mean (SD)
3.4 (4.97)
1.8 (10.13)
4.9 (7.49)
2.9 (4.58)
4.7 (10.09)
1.8 (6.08)
1.3 (12.89)
12.0 (15.19)
4.5 (2.21)
10.3 (14.86)
1.8 (6.08)
1.3 (12.89)
11.0 (13.78)
4.5 (2.21)
10.3 (14.86)
Control
Med.
2.5
3.8
7.0
4.5
3.2
2.5
5.1
10.2
5.1
5.1
2.5
5.1
8.3
5.1
5.1
Min, Max
-3, 10
-15, 11
-5, 15
-4, 6
-8, 32
-10, 9
-17, 17
-4, 31
1, 6
0, 53
-10, 9
-17, 17
-4, 31
1, 6
0, 53
Skin type and a treatment skin type interaction were not significant in this study indicating
consistent treatment effect trends in the patient sub-groups Table 13
Table 13
Observed Terminal Hair Count Change from Baseline by Skin Type and Treatment
Efficacy Subjects
Visit
Week 16
Week 26
Week 26 LOCF
Skin
Type
I
II
III
IV
I
II
III
IV
I
II
III
IV
N
6
20
29
12
5
19
28
12
6
20
29
12
Mean (SD)
23.3 (18.67)
24.8 (14.21)
20.3 (15.44)
11.9 (11.21)
18.6 (14.02)
25.3 (13.75)
20.6 (13.62)
11.2 (10.01)
24.2 (18.59)
26.6 (14.67)
21.8 (14.90)
11.2 (10.01)
Med.
20.4
22.3
21.6
14.0
20.4
22.9
19.1
7.6
22.3
22.9
19.1
7.6
Min, Max
1, 52
0, 57
-5, 56
-17, 25
4, 38
4, 57
-5, 48
0, 27
4, 52
4, 57
-5, 56
0, 27
Control
N
2
12
14
8
2
11
14
8
2
12
14
8
Mean (SD)
6.4 (12.60)
3.2 (4.99)
5.7 (9.26)
0.6 (7.70)
11.5 (18.01)
7.9 (8.84)
7.5 (15.32)
1.1 (8.65)
11.5 (18.01)
7.7 (8.44)
7.5 (15.32)
1.1 (8.65)

Med.
6.4
4.5
4.5
0.6
11.5
5.1
2.5
0.6
11.5
5.7
2.5
0.6
Min, Max
-3, 15
-5, 10
-8, 32
-15, 8
-1, 24
-4, 31
-10, 53
-17, 11
-1, 24
-4, 31
-10, 53
-17, 11
26
There were no statistically significant trends associated with baseline age category and no
evidence of treatment interaction Table 14
.
Table 14
Observed Terminal Hair Count Change from Baseline by Age Group and Treatment
Efficacy Subjects
Visit
Week 16
Week 26
Week 26 LOCF
Age
Group
25-43
44-50
51-61
25-43
44-50
51-61
25-43
44-50
51-61
N
17
21
29
17
20
27
17
21
29
Mean (SD)
19.1 (12.81)
22.6 (15.23)
19.7 (16.41)
19.5 (11.06)
20.5 (13.74)
20.1 (15.45)
19.5 (11.06)
22.2 (15.48)
22.3 (17.03)
Med.
19.1
21.6
17.8
16.6
19.7
17.8
16.6
20.4
22.9
Min, Max
-17, 34
-1, 56
-5, 57
0, 39
1, 48
-5, 57
0, 39
1, 56
-5, 57
Control
N
17
9
10
17
9
9
17
9
10
Mean (SD)
3.4 (9.02)
6.6 (5.76)
1.8 (6.90)
7.3 (14.66)
6.4 (9.82)
4.7 (9.65)
7.3 (14.66)
6.4 (9.82)
4.8 (9.12)
Med.
2.5
6.4
4.5
3.8
2.5
5.1
3.8
2.5
5.7
Min, Max
-8, 32
-3, 15
-15, 8
-10, 53
-6, 24
-17, 17
-10, 53
-6, 24
-17, 17
6.3 Tertiary Effectiveness Analysis

Methods for visually scoring the amount of hair growth have been in use for some time.
However, it has been found from many studies on hair growth, that this method is subject to
wide variability in photography, hair condition, style, length, moisture content, etc. which
renders the results unpredictable. Therefore, since standardization was also impossible to
accomplish in this study, subjective assessments from the subject and investigator were classified
as tertiary objectives.
6.3.1. Subject Questionnaire Overall Improvement of Hair Loss Condition
Results from the Subject Questionnaire are presented in Tables 15 and 16.
Table 15 showed that at Week 16, 58.2% of HairMax LaserComb 7, 9, 12 Beam subjects
reported at least minimal improvement in their hair loss condition, while only 33.3% of control
device subjects reported at least minimal improvement. Similar trends were noted at Week 26.
No statistically significant differences were found at any of the visits, though the trends appear to
be approaching significance at all visits.

27
Table 15
Subject Questionnaire Assessment of Overall Improvement of Hair Loss Condition
Efficacy Subjects
Summary
Number of Subjects
Week 8
Improved
Minimally Improved
No Change
Minimally Worse
Worse
Total
P-value1
Week 16
Improved
Minimally Improved
No Change
Minimally Worse
Worse
Total
P-value1
Week 26
Improved
Minimally Improved
No Change
Minimally Worse
Worse
Total
P-value1
Week 26 LOCF [2]
Improved
Minimally Improved
No Change
Minimally Worse
Worse
Total
P-value1
1
Treatment
HairMax
LaserComb 7, 9,
12 Beam
Control
67
36
8 (12.3%)
27 (41.5%)
29 (44.6%)
1 (1.5%)
0
65
0.0891
2 (5.7%)
13 (37.1%)
18 (51.4%)
1 (2.9%)
1 (2.9%)
35
9 (13.4%)
30 (44.8%)
27 (40.3%)
1 (1.5%)
0
67
0.0706
6 (16.7%)
6 (16.7%)
23 (63.9%)
1 (2.8%)
0
36
13 (21.0%)
24 (38.7%)
23 (37.1%)
2 (3.2%)
0
62
0.0841
4 (11.4%)
13 (37.1%)
15 (42.9%)
2 (5.7%)
1 (2.9%)
35
13 (19.4%)
27 (40.3%)
25 (37.3%)
2 (3.0%)
0
67
0.0717
4 (11.1%)
13 (36.1%)
16 (44.4%)
2 (5.6%)
1 (2.8%)
36
Cochran-Mantel-Haenszel row-mean score test with integer scores stratified by site.

28
6.3.2. Subject Assessment of Thickness and Fullness of Hair (Density)

Table 16 displays the results for subject assessment of thickness and fullness of hair (density).
Results were statistically significant for the observed Week 26 results (p = 0.0220) and the
LOCF analysis at Week 26 (p = 0.0114). The increase in statistical significance follows a
decrease in control device response over time compared to the HairMax LaserComb model arms,
showing a more durable response with the active treatment.

29
Table 16
Subject Questionnaire Assessment of Thickness and Fullness of Hair (Density)
Efficacy Subjects
Summary
Number of Subjects
Week 8
Improved
Minimally Improved
No Change
Minimally Worse
Worse
Total
P-value1
Week 16
Improved
Minimally Improved
No Change
Minimally Worse
Worse
Total
P-value1
Week 26
Improved
Minimally Improved
No Change
Minimally Worse
Worse
Total
P-value1
Week 26 LOCF [2]
Improved
Minimally Improved
No Change
Minimally Worse
Worse
Total
P-value1
1
Treatment
HairMax
LaserComb 7, 9,
12 Beam
Control
67
36
11 (16.9%)
19 (29.2%)
33 (50.8%)
2 (3.1%)
0
65
0.5456
6 (17.1%)
8 (22.9%)
19 (54.3%)
2 (5.7%)
0
35
11 (16.4%)
26 (38.8%)
28 (41.8%)
2 (3.0%)
0
67
0.2484
6 (16.7%)
9 (25.0%)
19 (52.8%)
2 (5.6%)
0
36
13 (21.0%)
22 (35.5%)
26 (41.9%)
1 (1.6%)
0
62
0.0220
3 (8.6%)
10 (28.6%)
20 (57.1%)
1 (2.9%)
1 (2.9%)
35
16 (23.9%)
22 (32.8%)
28 (41.8%)
1 (1.5%)
0
67
0.0114
3 (8.3%)
10 (27.8%)
21 (58.3%)
1 (2.8%)
1 (2.8%)
36
Cochran-Mantel-Haenszel row-mean score test with integer scores stratified by site.

30
6.3.3.
Investigator Global Assessment and Subject Questionnaire Results
Investigator overall assessment of hair growth is summarized in Table 17 for the Week 26 or
Early Termination Visit. Significance was not reached between the HairMax LaserComb 7, 9,
12 Beam compared to the control device.
Table 17
Investigator Assessment of Global Hair Growth
Efficacy Subjects
Treatment
Summary
Number of Subjects
Week 26 or Early Termination
Visit
Dense Growth
Moderate Growth
Minimal Growth
No Growth
Total
P-value1
1
HairMax
LaserComb 7, 9,
12 Beam
67
1 (1.5%)
10 (15.4%)
22 (33.8%)
32 (49.2%)
65
Control
36
0
6 (17.1%)
9 (25.7%)
20 (57.1%)
35
0.4924
Cochran-Mantel-Haenszel row-mean score test with integer scores stratified by site
Since these results were not in agreement with the primary efficacy results based on objective
measures, additional post-hoc analyses were completed to assess the association of these
measures with the objective efficacy outcomes. The data show a positive relationship between
observed hair count and investigator assessment in those subjects with >=20 hairs/cm in hair
count vs. those with <5 hairs/cm increase in hair count. The results are shown in Table 18
below.
Investigators assesses the category of minimal growth/moderate growth in 55.9% of subjects
with >=20 hairs/cm increase in hair count vs. only 39.3% of subjects with <5 hairs/cm increase
in hair count.

31
Table 18
Investigator Assessment of Global Hair Growth by Terminal Hair Count Change (>=20, <5)
Efficacy Subjects
Summary
Week 26
Dense Growth
Moderate Growth
Minimal Growth
No Growth
Total
P-value [1]
Terminal Hair Count Change from

Baseline
>= 20
<5
0
4 (11.8%)
15 (44.1%)
15 (44.1%)
34
0.7167
0
6 (21.4%)
5 (17.9%)
17 (60.7%)
28
These data, while not significant, indicate the presence of a correlation between objective
response and investigator global assessment. It is believed that had the cohort size been
substantially larger, these data might have approached significance.
6.3.4. Perceived Treatment Group
Subjects were asked to guess which device they believe they had been using at each of the
scheduled visits. Results are provided in Table 19 and suggest that there was positive correlation
( equal to 0) between a subjects treatment assignment and their perceived treatment group.
Fewer subjects thought they received the active treatment as the study progressed. All of the
95% confidence intervals contained zero, indicating the kappa statistics were not statistically
significantly different from 0 (no correlation). The correlation implies a successful blinding of
the study and some positive correlations is expected when an active treatment is working better
than control.

32
Table 19
Subject Perception of Treatment Group
Efficacy Subjects
Assessment
Week 8 Perceived Treatment
HairMax LaserComb 7, 9,
12 Beam
Control
Total
12 Beam
Control
Total
12 Beam
Control
Total
HairMax
LaserComb
7, 9, 12 Beam
Control
Kappa Statistic
[1]/ 95% CI
38 (67.9%)
18 (32.1%)
56
18 (58.1%) 0.10 (-0.11,0.31)

13 (41.9%)
31
32 (56.1%)
25 (43.9%)
57
13 (41.9%) 0.13 (-0.07,0.33)

18 (58.1%)
31
29 (52.7%)
26 (47.3%)
55
11 (35.5%) 0.16 (-0.04,0.35)

20 (64.5%)
31
6.4. Analyses of Safety (See Appendix For Non-Pooled Data)

Table 20 displays the summary of adverse events by System Organ Class and Preferred Term.
Skin and subcutaneous tissue disorders represented the most common types of adverse events,
the most frequent of those being application site pruritus. No other adverse event occurred in
more than 10% of subjects within a treatment group, and no significant differences were found
between the HairMax LaserComb 7, 9, 12 Beam device compared to the control device.

33
Table 20
Adverse Events
Safety Subjects
Summary
Number of Subjects
Subjects with one or more adverse
events
Skin and subcutaneous tissue
disorders
Application site pruritus
Dry skin
Dandruff
Folliculitis
Skin laceration
Acne
Alopecia
Scalp tenderness
Seborrhoeic dermatitis
Skin exfoliation
Skin irritation
Infections and infestations
Upper respiratory tract infection
Nasopharyngitis
Rhinitis
Furuncle
Infection
Tooth abscess
Respiratory, thoracic and
mediastinal disorders
Productive cough
Rhinorrhoea
Nasal congestion
Pharyngolaryngeal pain
Chest pain
Cough
General disorders and
administration site conditions
Application site warmth
Pyrexia
Application site rash
Pain
Treatment
HairMax
LaserComb
7, 9, 12 Beam
Control
79
40
32 (40.5%)
12 (30.0%)
P-value1
12 (15.2%)
4 (5.1%)
3 (3.8%)
2 (2.5%)
1 (1.3%)
2 (2.5%)
1 (1.3%)
1 (1.3%)
1 (1.3%)
1 (1.3%)
1 (1.3%)
1 (1.3%)
3 (7.5%)
2 (5.0%)
1 (2.5%)
0
1 (2.5%)
0
0
0
0
0
0
0
0.3806
1.0000
1.0000
0.5499
1.0000
0.5499
1.0000
1.0000
1.0000
1.0000
1.0000
1.0000
11 (13.9%)
5 (6.3%)
2 (2.5%)
1 (1.3%)
1 (1.3%)
1 (1.3%)
1 (1.3%)
6 (7.6%)
2 (2.5%)
2 (2.5%)
1 (1.3%)
1 (1.3%)
1 (1.3%)
0
2 (5.0%)
1 (2.5%)
0
1 (2.5%)
0
0
0
3 (7.5%)
1 (2.5%)
1 (2.5%)
1 (2.5%)
1 (2.5%)
0
1 (2.5%)
0.2146
0.6623
0.5499
1.0000
1.0000
1.0000
1.0000
1.0000
1.0000
1.0000
1.0000
1.0000
1.0000
0.3361
4 (5.1%)
1 (1.3%)
2 (2.5%)
1 (1.3%)
0
4 (10.0%)
3 (7.5%)
0
0
1 (2.5%)
0.4396
0.1098
0.5499
1.0000
0.3361

34
Table 20
Adverse Events
Safety Subjects
Summary
Nervous system disorders
Headache
Dizziness
Facial palsy
Insomnia
Paraesthesia
Skin burning sensation
Gastrointestinal disorders
Vomiting
Diarrhoea
Gingival infection
Oral herpes
Musculoskeletal and connective
tissue disorders
Musculoskeletal pain
Flank pain
Foot fracture
Muscle injury
Pain in extremity
Vascular disorders
Contusion
Haemangioma
Hypertension
Migraine
Injury, poisoning and procedural
complications
Sunburn
Clavicle fracture
Joint injury
Metabolism and nutrition
disorders
Diabetes mellitus non-insulindependent
Hypokalaemia
Blood and lymphatic system
disorders
Leukopenia
Treatment
HairMax
LaserComb
7, 9, 12 Beam
Control
7 (8.9%)
1 (2.5%)
3 (3.8%)
1 (2.5%)
1 (1.3%)
0
1 (1.3%)
0
1 (1.3%)
0
1 (1.3%)
0
0
1 (2.5%)
3 (3.8%)
2 (5.0%)
2 (2.5%)
1 (2.5%)
2 (2.5%)
0
0
1 (2.5%)
1 (1.3%)
0
3 (3.8%)
1 (2.5%)
2 (2.5%)
0
1 (1.3%)
0
1 (1.3%)
0
0
1 (2.5%)
0
1 (2.5%)
P-value1
0.2645
1.0000
1.0000
1.0000
1.0000
1.0000
0.3361
1.0000
1.0000
0.5499
0.3361
1.0000
1.0000
0.5499
1.0000
1.0000
0.3361
0.3361
2 (2.5%)
1 (1.3%)
0
1 (1.3%)
0
3 (3.8%)
2 (2.5%)
1 (1.3%)
1 (1.3%)
2 (5.0%)
0
1 (2.5%)
0
1 (2.5%)
0
0
0
0
0.6017
1.0000
0.3361
1.0000
0.3361
0.5499
0.5499
1.0000
1.0000
2 (2.5%)
1 (1.3%)
1 (1.3%)
0
0
0
0.5499
1.0000
1.0000
1 (1.3%)
1 (1.3%)
0
0
1.0000
1.0000

35
Table 20
Adverse Events
Safety Subjects
Summary
Cardiac disorders
Sudden death
Eye disorders
Lacrimation increased
Immune system disorders
Seasonal allergy
Investigations
Blood pressure increased
Surgical and medical procedures
Foot operation
1
Treatment
HairMax
LaserComb
7, 9, 12 Beam
Control
0
1 (2.5%)
0
1 (2.5%)
0
1 (2.5%)
0
1 (2.5%)
1 (1.3%)
0
1 (1.3%)
0
1 (1.3%)
0
1 (1.3%)
0
1 (1.3%)
0
1 (1.3%)
0
P-value1
0.3361
0.3361
0.3361
0.3361
1.0000
1.0000
1.0000
1.0000
1.0000
1.0000
Fishers Exact test.
Table 21 summarizes those adverse events that were reported as being related to the study
device. Seven subjects experienced adverse events that were considered to be related to the
study device, the most common being adverse events classified as skin and subcutaneous tissue
disorders. No device-related adverse event was experienced by more than 5.1% of HairMax
LaserComb 7, 9, 12 Beam subjects or 7.5% of control device subjects. No significant
differences were found between HairMax LaserComb 7, 9, 12 Beam compared to the control
device.

36
Table 21
Device-Related Adverse Events
Safety Subjects
Summary
Number of Subjects
Subjects with one or more adverse
events
Skin and subcutaneous tissue disorders
Dry skin
Scalp tenderness
Skin irritation
General disorders and administration
site conditions
Headache
Vascular disorders
Migraine
1
Fishers Exact test.
Treatment
HairMax
LaserComb
7, 9, 12 Beam
Control
79
40
4 (5.1%)
3 (7.5%)
P-value1
4 (5.1%)
2 (2.5%)
1 (1.3%)
1 (1.3%)
1 (1.3%)
1 (1.3%)
1 (1.3%)
1 (2.5%)
1 (2.5%)
1 (2.5%)
0
0
3 (7.5%)
3 (7.5%)
0.6623
1.0000
1.0000
1.0000
1.0000
0.1098
0.1098
0
0
0
0
0
1 (2.5%)
1 (2.5%)
1 (2.5%)
1 (2.5%)
1 (2.5%)
0.3361
0.3361
0.3361
0.3361
0.3361
Table 22 displays all adverse events by severity. Only one control device subject experienced a
severe adverse events relating to a muscle injury and not to the device, and no subjects in the
HairMax LaserComb 7, 9, 12 Beam group experienced a severe adverse event. No more than
19% of subjects in either of the treatment groups experienced a moderate adverse event and such
events were not dissimilar across the treatment arms.
(Note: One control device subject died during the study which was not related to the device)

37
Table 22
Adverse Events by Severity
Safety Subjects
HairMax LaserComb 7, 9, 12
Beam
(N=79)
Summary
Mild Moderate Severe
Subject Maximum Severity Across
17
15
0
All Adverse Events
(21.5%) (19.0%) (0.0%)
11
2
0
disorders
0
(13.9%) (2.5%)
2 (2.5%) 2 (2.5%) 0
3 (3.8%) 0
0
Dry skin
1 (1.3%) 1 (1.3%) 0
Dandruff
1 (1.3%) 0
0
Folliculitis
2 (2.5%) 0
0
Skin laceration
1 (1.3%) 0
0
Acne
1 (1.3%) 0
0
Alopecia
1 (1.3%) 0
0
Scalp tenderness
1 (1.3%) 0
0
1 (1.3%) 0
0
Skin exfoliation
1 (1.3%) 0
Skin irritation
6
5
0
(6.3%) (7.6%)
0
Nasopharyngitis
2 (2.5%) 3 (3.8%) 0
1 (1.3%) 1 (1.3%) 0
Rhinitis
Furuncle
0
1 (1.3%) 0
Infection
1 (1.3%) 0
0
1 (1.3%) 0
Tooth abscess
0
0
1 (1.3%)
Respiratory, thoracic and mediastinal 2
4
0
disorders
(2.5%) (5.1%)
0
Productive cough
0
2 (2.5%) 0
Rhinorrhoea
1 (1.3%) 1 (1.3%) 0
Nasal congestion
0
1 (1.3%) 0
1 (1.3%) 0
0
Chest pain
0
1 (1.3%) 0
Cough
0
0
General disorders and administration
3
1
0
site conditions
(3.8%) (1.3%)
0
1 (1.3%) 0
0
Pyrexia
2 (2.5%) 0
0
0
1 (1.3%) 0
Pain
0
0
Control
(N=40)
Mild
3
(7.5%)
3
(7.5%)
2 (5.0%)
1 (2.5%)
0
1 (2.5%)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Moderate Severe
7
1
(17.5%) (2.5%)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2
(5.0%)
1 (2.5%)
0
1 (2.5%)
0
0
0
0
3
0
(7.5%)
0
1 (2.5%)
0
1 (2.5%)
0
1 (2.5%)
0
1 (2.5%)
0
0
1 (2.5%)
3
1
(7.5%) (2.5%)
3 (7.5%) 0
0
0
0
0
0
1 (2.5%)

0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
38
Table 22
Safety Subjects
Summary
Headache
Dizziness
Facial palsy
Insomnia
Paraesthesia
Vomiting
Diarrhoea
Gingival infection
Oral herpes
tissue disorders
Flank pain
Foot fracture
Muscle injury
Pain in extremity
Vascular disorders
Contusion
Haemangioma
Hypertension
Migraine
complications
Sunburn
Clavicle fracture
Joint injury
Metabolism and nutrition disorders
Diabetes mellitus non-insulindependent
Hypokalaemia
Control
Beam
(N=40)
(N=79)
Mild Moderate
4
3
0
1
0
(5.1%) (3.8%)
0
(2.5%)
0
1 (1.3%) 2 (2.5%) 0
1 (2.5%) 0
1 (1.3%) 0
0
0
0
0
1 (1.3%) 0
0
0
1 (1.3%) 0
0
0
0
1 (1.3%) 0
0
0
0
0
1 (2.5%)
0
2
1
0
0
2
(2.5%) (1.3%)
0
0
(5.0%)
1 (1.3%) 1 (1.3%) 0
0
1 (2.5%)
1 (1.3%) 1 (1.3%) 0
0
0
0
0
0
0
1 (2.5%)
0
1 (1.3%) 0
1
2
0
0
0
(1.3%) (2.5%)
0
0
0
0
0
1 (1.3%) 1 (1.3%) 0
0
1 (1.3%) 0
0
0
0
1 (1.3%) 0
0
0
0
0
0
0
0
0
0
0
0
1
2
1
0
0
(2.5%) (2.5%)
(2.5%)
0
0
0
1 (1.3%) 0
0
0
0
1 (2.5%) 0
1 (1.3%) 0
0
0
0
0
0
1 (2.5%)
3
0
0
0
0
(3.8%)
0
0
0
0
2 (2.5%) 0
0
0
0
1 (1.3%) 0
0
0
0
1 (1.3%)
2
0
0
0
0
(2.5%)
0
0
0
0
1 (1.3%) 0
0
0
0
1 (1.3%)

Severe
0
0
0
0
0
0
0
0
0
0
0
0
1
(2.5%)
0
0
0
1 (2.5%)
1 (2.5%)
0
0
0
0
0
0
0
0
0
0
0
0
39
Table 22
Safety Subjects
Beam
(N=79)
1
0
0
(1.3%)
0
0
1 (1.3%)
0
0
0
0
0
0
Summary
disorders
Leukopenia
Eye disorders
Seasonal allergy
0
0
Investigations
Foot operation
1
(1.3%)
1 (1.3%)
1
(1.3%)
1 (1.3%)
1
(1.3%)
1 (1.3%)
0
0
0
0
Control
(N=40)
Mild
0
0
0
0
Moderate Severe
0
0
0
0
1
(2.5%)
1 (2.5%)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Table 23 displays all adverse events by action taken. Only three subjects (2 HairMax
LaserComb 7, 9, 12 Beam subjects and 1 control device subject) experienced an adverse event
that resulted in the discontinuation of the study product, while only one HairMax LaserComb 7,
9, 12 Beam subject experienced an adverse event that resulted in the interruption of the study
product. All other adverse events had no impact on the study product.
Table 23
Adverse Events by Action Taken
Safety Subjects
Beam
(N=79)
Interrupt
Summary
None
ed
Discon.
None
Subject Most Severe Action Taken 29
1
2
11
Across All Adverse Events
(36.7%) (1.3%) (2.5%) (27.5%)

Control
(N=40)
Interrupt
ed
Discon.
0
1
(0.0%) (2.5%)
40
Table 23
Safety Subjects
Summary
disorders
Dry skin
Dandruff
Folliculitis
Skin laceration
Acne
Alopecia
Scalp tenderness
Skin exfoliation
Skin irritation
Nasopharyngitis
Rhinitis
Furuncle
Infection
Tooth abscess
Respiratory, thoracic and
mediastinal disorders
Productive cough
Rhinorrhoea
Nasal congestion
Chest pain
Cough
General disorders and
administration site conditions
Pyrexia
Pain
Beam
(N=79)
Interrupt
None
ed
Discon.
11
0
1
0
(1.3%)
(13.9%)
3 (3.8%) 0
1 (1.3%)
3 (3.8%) 0
0
1 (1.3%)
1 (1.3%) 0
1 (1.3%) 0
0
2 (2.5%) 0
0
1 (1.3%) 0
0
0
0
1 (1.3%)
1 (1.3%) 0
0
1 (1.3%) 0
0
1 (1.3%) 0
0
1 (1.3%)
0
11
0
0
(13.9%)
0
0
5 (6.3%) 0
0
0
2 (2.5%) 0
1 (1.3%) 0
0
1 (1.3%) 0
0
1 (1.3%) 0
0
1 (1.3%)
6
0
0
(7.6%)
0
0
2 (2.5%) 0
0
2 (2.5%) 0
0
1 (1.3%) 0
0
1 (1.3%) 0
0
1 (1.3%) 0
0
0
3
0
1
(3.8%)
0
(1.3%)
0
0
1 (1.3%)
2 (2.5%) 0
0
1 (1.3%) 0
0
0
0
Control
(N=40)
None
3
(7.5%)
2 (5.0%)
1 (2.5%)
0
1 (2.5%)
0
0
0
0
0
0
0
2
(5.0%)
1 (2.5%)
0
1 (2.5%)
0
0
0
3
(7.5%)
1 (2.5%)
1 (2.5%)
1 (2.5%)
1 (2.5%)
0
1 (2.5%)
4
(10.0%)
3 (7.5%)
0
0
1 (2.5%)

Interrupt
ed
Discon.
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
41
Table 23
Safety Subjects
Beam
(N=79)
Interrupt
Summary
None
ed
Discon.
7
0
0
Headache
(8.9%)
0
0
Dizziness
3 (3.8%) 0
0
Facial palsy
1 (1.3%) 0
0
Insomnia
1 (1.3%) 0
0
Paraesthesia
1 (1.3%) 0
0
1 (1.3%) 0
0
0
3
0
0
Vomiting
(3.8%)
0
0
Diarrhoea
2 (2.5%) 0
0
Gingival infection
0
2 (2.5%) 0
Oral herpes
0
0
0
1 (1.3%)
2
0
1
tissue disorders
(2.5%)
0
(1.3%)
2 (2.5%) 0
0
Flank pain
1 (1.3%) 0
0
Foot fracture
0
0
1 (1.3%)
Muscle injury
0
0
0
Pain in extremity
0
0
0
0
Vascular disorders
2
0
0
Contusion
(2.5%)
0
Haemangioma
1 (1.3%) 0
Hypertension
0
0
0
0
Migraine
1 (1.3%) 0
0
2
1
0
complications
(2.5%) (1.3%)
0
Sunburn
1 (1.3%) 1 (1.3%) 0
Clavicle fracture
1 (1.3%) 0
0
Joint injury
1 (1.3%) 0
Metabolism and nutrition disorders 2
0
0
Diabetes mellitus non-insulin(2.5%)
0
0
dependent
1 (1.3%) 0
0
Hypokalaemia
1 (1.3%)
Control
(N=40)
None
1
(2.5%)
1 (2.5%)
0
0
0
0
1 (2.5%)
2
(5.0%)
1 (2.5%)
0
1 (2.5%)
0
1
(2.5%)
0
0
0
1 (2.5%)
1 (2.5%)
2
(5.0%)
0
1 (2.5%)
0
1 (2.5%)
0
0
0
0
0
0
0

Interrupt
ed
Discon.
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
42
Table 23
Safety Subjects
Beam
(N=79)
Interrupt
None
ed
Discon.
1
0
0
(1.3%)
0
0
1 (1.3%)
0
0
0
0
0
0
Summary
disorders
Leukopenia
Cardiac disorders
Sudden death
Eye disorders
0
0

Seasonal allergy
Investigations
Foot operation
1
(1.3%)
1 (1.3%)
1
(1.3%)
1 (1.3%)
1
(1.3%)
1 (1.3%)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Control
(N=40)
None
0
0
0
0
1
(2.5%)
1 (2.5%)
0
0
Interrupt
ed
Discon.
0
0
0
0
0
0
0
0
1
(2.5%)
1 (2.5%)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Table 24 summarizes vital sign results. There were no significant differences between HairMax
LaserComb 9 or HairMax LaserComb 12 compared to the control device using a two-sample ttest testing the null hypothesis that the mean change from baseline in systolic blood pressure,
diastolic blood pressure,

43
Table 24
Vital Signs Results and Change from Baseline Values by Visit
Safety Subjects
Measure
Systolic BP
(mmHg)
Treatment
Visit
HairMax
Screening
LaserComb 7, 9,
12 Beam
Baseline
Week 8
Week 16
Week 26
Control
Screening
Baseline
Week 8
Week 16
Week 26
Diastolic BP HairMax
Screening
(mmHg)
LaserComb 7, 9,
12 Beam
Baseline
Week 8
Week 16
Week 26
Control
Screening
Baseline
Week 8
Week 16
Week 26
Observed Values
N Mean (SD) Median Min, Max N
78 124.8 (13.68) 124.0
96, 165
45
74
68
65
39
17
37
36
36
78
125.2 (13.20)
128.5 (15.49)
128.9 (15.27)
127.0 (15.40)
126.4 (12.40)
126.5 (12.03)
128.5 (13.55)
127.0 (11.67)
128.6 (11.37)
77.6 (9.46)
123.0
129.0
128.5
125.0
125.0
128.0
126.0
125.0
128.5
78.0
104, 165
98, 174
92, 170
102, 177
106, 164
100, 145
98, 160
110, 166
102, 159
60, 104
45 79.5 (10.02)
74 78.6 (10.02)
68 77.2 (10.21)
65 76.8 (8.96)
39 78.1 (9.80)
17 78.0 (9.96)
37 77.9 (8.36)
36 77.9 (9.70)
36 79.8 (9.05)
80.0
78.0
76.5
76.0
79.0
79.0
80.0
78.5
80.0
62, 110
60, 102
53, 104
61, 106
60, 102
64, 102
60, 95
60, 99
60, 99
43
39
38
Change from Baseline

Mean (SD) Median Min, Max
1.5 (14.52)
4.1 (17.07)
1.0 (16.22)
1.0
5.0
-2.0
-35, 36
-45, 41
-34, 51
16 -0.6 (15.36)
14 -0.1 (14.30)
14 6.1 (12.98)
-4.0
-0.5
7.5
-24, 39
-26, 33
-14, 34
43
39
38
-0.3 (9.78)
-1.4 (9.28)
-3.2 (9.32)
0.0
-2.0
-4.0
-24, 28
-21, 18
-24, 20
16
14
14
-1.3 (9.41)
1.1 (11.45)
4.1 (10.55)
-1.5
2.5
7.0
-21, 17
-23, 14
-18, 18

P-value1
0.6302
0.4158
0.2944
0.7518
0.4284
0.0192
44
Table 24
Vital Signs Results and Change from Baseline Values by Visit
Safety Subjects
Measure
Pulse Rate
(bpm)
Treatment
Visit
HairMax
Screening
LaserComb 7, 9,
12 Beam
Baseline
Week 8
Week 16
Week 26
Control
Screening
Baseline
Week 8
Week 16
Week 26
1
Two-sample t-test
Observed Values
N Mean (SD) Median Min, Max N
78 71.3 (10.45)
69.5
48, 100
44
74
68
65
39
17
37
36
36
71.5 (9.76)
75.9 (12.64)
71.9 (9.68)
72.6 (10.83)
69.1 (8.98)
70.4 (10.85)
70.5 (7.46)
71.4 (10.16)
71.4 (8.46)
71.0
74.5
70.0
69.0
70.0
70.0
71.0
70.5
71.0
53, 94
54, 106
56, 97
57, 100
43, 86
56, 94
52, 84
52, 98
54, 89
42
39
38
Change from Baseline

Mean (SD) Median Min, Max
5.4 (10.66)
2.7 (8.89)
3.8 (9.15)
4.0
2.0
3.5
-17, 37
-14, 22
-20, 19
16 -2.3 (13.19)
14 -2.6 (12.24)
14 -0.1 (11.19)
-1.5
0.0
1.5
-42, 14
-39, 9
-26, 13

P-value1
0.0257
0.0867
0.2130
45
Table 25
Terminal Hair Count Change from Baseline Summary by LaserComb Device
Last Observation Carried Forward
Efficacy Subjects
Summary
Number of Subjects
Week 16
N
Mean (SD)
Median
Min, Max
P-value [1]
Week 26
N
Mean (SD)
Median
Min, Max
P-value [1]
LaserComb 7
24
Treatment
LaserComb 9 LaserComb 12
21
22
Control
36
24
17.7 (12.83)
17.8
-16.6, 49.7
0.0023
21
20.4 (14.52)
19.1
-1.3, 57.3
0.0001
22
23.5 (17.67)
21.0
-5.1, 56.0
<.0001
36
3.8 (7.77)
3.8
-15.3, 31.8
24
18.4 (13.78)
16.6
-5.1, 48.4
0.0011
21
20.9 (14.08)
17.8
2.5, 57.3
0.0090
22
25.7 (16.92)
25.5
-3.8, 56.0
0.0001
36
6.4 (11.95)
5.1
-16.6, 53.5

7.0. Conclusion
The results of the clinical studies showed that the HairMax LaserComb 7, 9, 12 Beam
devices were safe and effective in the promotion of hair growth and in the cessation of hair
loss in males diagnosed with androgenetic alopecia when treatment is applied three times
per week on non-concurring days a week (i.e. Monday, Wednesday, Friday) for 26 weeks.

Appendix I -Macro Photos -1

Sample photos from Study
Baseline to 26 Weeks
Un-retouched photos

Appendix I -Macro Photos -2

Un-retouched photos

Appendix II Global Photos - 1

Un-retouched photos


Un-retouched photos


Un-retouched photos


Un-retouched photos
End of Document

Final Clinical Study Report

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Final Clinical Study Report

Pooled Study Results for Two Randomized, Double-Blind, Device Controlled

Subject Population and Demographics

Prospective subject is male with a diagnosis of androgenetic alopecia according to the

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Prospective subject must be in good general health.

Prospective subject must have a Norwood-Hamilton classification of IIa to V.

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Prospective subject has a history of hypogonadism.

Prospective subject has photosensitivity to laser light.

Prospective subject has used Accutane in the previous year.

Prospective subject has a history of poor wound healing.

Prospective subject has a history of keloid formation.

Prospective subject has chronic dermatological condition (eczema, psoriasis, infection,

Prospective subject has a pacemaker, defibrillator or other active implantable device.

Visit 1 Screening (Day-14)

Visit 2 Baseline (Day 0)

target site area identification

global digital images(must be taken prior to the hair clipping/tattooing)

macro imaging (final determination if subject may be enrolled)

diary dispensing and instructions.

3.2.1. Target Site Area Identification

3.2.3. Hair Clipping

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Visit 3 (Week 8) and Visit 4 (Week 16)

global digital images (must be taken prior to the hair clipping/tattooing).

hair clipping and re-tattooing if necessary

questionnaire for subjects static assessments of hair regrowth

dermatological scalp assessment at Visit 4

Phone Follow Up Visit (Week 21) (7 days)

Safety assessment for adverse events

Reminded subject to return diary, questionnaire and LaserComb device at Visit 5

All subjective information recorded in EDC

Visit 5 (Week 26) or Early Termination LOCF

global digital images

macro imaging uploaded to EDC and hair count

questionnaire and dairies collected

dermatological scalp assessment

4. Pre-Specified Study Endpoints

Primary Effectiveness Endpoint

Secondary Effectiveness Endpoint

Secondary effectiveness endpoints include the following measures:

Categorical change from baseline in terminal hair count.

Tertiary effectiveness endpoints include the following measures:

Investigators global assessment of hair regrowth at the last visit.

5. Description of Statistical Methods

Sample Size Calculations

Primary Effectiveness Analysis

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Secondary Effectiveness Analysis

5.5.1. Categorical Change from Baseline in Terminal Hair Count

Tertiary Endpoints Analysis

5.6.1. Subject and Investigator Questionnaires

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5.6.2. Perceived Treatment Group

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Table 3 summarizes the demographic characteristics of subjects by treatment group. No

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Fishers Exact test.

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