Dermicol-P35 Collagen - Techniques in Facial and Hand Rejuvenation (2009)

Volume 29 Number 3S May/June 2009
Dermicol-P35 Collagen: Techniques in Facial and Hand Rejuvenation

Supplement to Aesthetic Surgery Journal
Table of Contents
S1 CME INFORMATION
www.aestheticsurgeryjournal.com
S3 INTRODUCTION THE SCIENCE AND TECHNOLOGY OF DERMICOL-P35: UTILITY AND SAFETY IN AESTHETIC PROCEDURES
Robert W. Bernard, MD
S5 CHEEK AUGMENTATION WITH DERMICOL-P35 27G

Neil S. Sadick, MD; and Laura Palmisano, RPA-C
S9 CORRECTION OF TEAR TROUGH DEFORMITY WITH NOVEL PORCINE COLLAGEN DERMAL FILLER (DERMICOL-P35)
David J. Goldberg, MD, JD
S12 LIP AUGMENTATION AND REJUVENATION USING DERMICOL-P35 30G: PERSONAL EXPERIENCES FROM MY CLINIC
Marina Landau, MD
S16 REPAIR OF ACNE SCARS WITH DERMICOL-P35

Kevin C. Smith, MD
S19 NONSURGICAL HAND REJUVENATION WITH DERMICOL-P35 30G

Christopher Inglefield, BSc, MBBS
S22 THE USE OF DERMICOL-P35 DERMAL FILLER FOR NONSURGICAL RHINOPLASTY

Daniel Cassuto, MD
This CME supplement is to be published July 2009. This activity is jointly sponsored by the Elsevier Office of Continuing Medical Education and Aesthetic Surgery Journal and is supported by an educational grant from Ortho Dermatologics, Inc.
A1
Contentscontinued
S25 CME TEST QUESTIONS S26 CME ASSESSMENT TEST ANSWER SHEET S27 CME EVALUATION FORM
Editors Note: As of 2006, Allergan completed acquisition of Inamed (Santa Barbera, CA), so all have been changed to reflect the merger.
To submit your manuscript online to Aesthetic Surgery Journal visit www.aestheticsurgeryjournal.com

The opinions or views expressed in this professional education supplement are those of the authors and do not necessarily reflect the opinions or recommendations of Ortho Dermatologics, Inc. Dosages, indications, and methods of use for products that are referred to in the supplement by the authors may reflect their clinical experience or may be derived from the professional literature or other clinical sources. Because of the differences between in vitro and in vivo systems and between laboratory animal models and clinical data in humans, in vitro and animal data may not necessarily correlate with clinical results.
A2 Volume 29 Number 3S May/June 2009
Volume 29 Number 3S May/June 2009
Aesthetic Surgery Journal

A Peer-Reviewed International Journal P R i dI t ti lJ l
www.aestheticsurgeryjournal.com Founding Editor
Editor Emeritus
Stanley A. Klatsky, MD
Editorial Board
Editor in Chief
Foad Nahai, MD
Clinical Professor of Plastic Surgery Emory University School of Medicine
Research David L. Larson, MD

Chairman and George J. Korkos Professor of Plastic and Reconstructive Surgery Medical College of Wisconsin
Associate Editor
Jeffrey M. Kenkel, MD
Professor and Vice-Chairman, Department of Plastic Surgery University of Texas Southwestern Medical Center
Featured Operative Techniques Editor

Michael J. Yaremchuk, MD
Clinical Professor of Surgery Division of Plastic and Reconstructive Surgery Harvard Medical School
Section Editors
Facial Surgery Fritz E. Barton, Jr., MD
Clinical Professor of Plastic Surgery University of Texas Southwestern Medical Center
CME Editor
Richard J. Warren, MD
Clinical Professor Division of Plastic Surgery, Department of Surgery University of British Columbia
Oculoplastic Surgery James. H. Carraway, MD

Professor and Chairman, Division of Plastic Surgery Eastern Virginia Medical School
Editors
A. Jay Burns, MD
Assistant Professor of Plastic Surgery University of Texas Southwestern Medical Center
Rhinoplasty Bahman Guyuron, MD

Kiehn-DesPrez Professor and Chief Division of Plastic Surgery Case Western Reserve University and University Hospitals Case Medical Center
James Grotting, MD, FACS

Clinical Professor of Surgery, Division of Plastic Surgery University of Alabama at Birmingham and University of Wisconsin, Madison
Breast Surgery Laurie A. Casas, MD

Associate Professor Division of Plastic and Reconstructive Surgery Department of Surgery Northwestern University Feinberg School of Medicine
Dennis J. Hurwitz, MD
Clinical Professor of Surgery (Plastic) University of Pittsburgh Medical Center
Mary McGrath, MD, MPH

Professor of Surgery, Division of Plastic Surgery University of California San Francisco
Body Contouring Al Aly, MD

Clinical Professor of Plastic Surgery University of California at Irvine
Peter J. Rubin, MD
Director, Body Contouring Program Associate Professor of Plastic Surgery University of Pittsburgh
Cosmetic Medicine Alan Matarasso, MD

Clinical Professor Department of Plastic and Reconstructive Surgery Albert Einstein College of Medicine
Graeme Southwick, MB, BS, FRACS, FACS

Honorary Senior Lecturer Department of Anatomy and Cell Biology Montash University, Australia
Continued
A3
Editorial Board continued

Berish Strauch, MD
Professor and Chairman Emeritus Department of Plastic and Reconstructive Surgery Albert Einstein College of Medicine
Daniel G. Becker, MD
Clinical Associate Professor Division of Facial Plastic and Reconstructive Surgery Department of Otolaryngology-Head and Neck Surgery University of Pennsylvania Medical Center and University of Virginia Medical Center
Luis Vasconez, MD
Professor and Director Division of Plastic Surgery, Department of Surgery University of Alabama-Birmingham School of Medicine
Michael Grant, MD, PhD, FACS

Assistant Professor of Ophthalmology and Plastic Surgery Wilmer Eye Institute at John Hopkins
James Zins, MD
Chairman, Department of Plastic Surgery Cleveland Clinic
Thomas E. Joiner, MD
Distinguished Research Professor & Bright-Burton Professor of Psychology Florida State University
Statistical Editor
Navin K. Singh, MD, MBA
Assistant Professor of Plastic Surgery The Johns Hopkins University School of Medicine
Seth Matarasso, MD
Clinical Professor of Dermatology University of California School of Medicine San Francisco, CA
Deborah S. Sarnoff, MD, FAAD, FACP
International Editors
Alberto Arguello, MD
Professor of Plastic Surgery University of Costa Rica San Jose, Costa Rica
Clinical Professor Department of Dermatology NYU Medical Center
Editorial Staff
Managing Editor - Melissa Knoll Editorial Consultant - Elizabeth Sadati Bernard Freelance Manuscript Editor - Paul Bernstein Journal Manager - Beth Schad Journal Composition Designer - Gwen Eckenrode
Jenny Carvajal, MD
Medellin, Colombia
Claudio Cardoso de Castro, MD

Chief and Professor University of the State of Rio de Janeiro Rio de Janeiro, Brazil
Apirag Chuangsuwanich, MD
Associate Professor, Faculty of Medicine Sirirraj Hospital, Mahidol University Bangkok, Thailand
Seum Chung, MD
Clinical Professor of Plastic Surgery Yonsei College of Medicine Seoul, South Korea
OFFICIAL ENGLISH-LANGUAGE JOURNAL OF:

Brazilian Society of Plastic Surgery Colombian Society of Plastic, Aesthetic, Maxillofacial, and Hand Surgery Costa Rican Association of Plastic, Reconstructive, and Aesthetic Surgery Dutch Society for Aesthetic Plastic Surgery Indian Association of Aesthetic Plastic Surgeons Israel Society for Plastic Surgeons Japan Society of Aesthetic Plastic Surgery Korean Society for Aesthetic Plastic Surgery Mexican Association of Plastic, Aesthetic, and Reconstructive Surgery Society of Plastic and Reconstructive Surgeons of Thailand
Lokesh Kumar, MD
Senior Consultant Plastic Surgeon Department of Plastic & Reconstructive Surgery Indraprastha Apollo Hospital New Delhi, India
Roland Luijendijk, MD, PhD

Chairman, Department of Plastic and Reconstructive Surgery Diakonessenhuis, Utrecht, the Netherlands
Fernando Magallanes, MD
Mexico City, Mexico
Kitaro Ohmori, MD
Tokyo, Japan
OFFICIAL JOURNAL OF:

The Rhinoplasty Society
Michael Scheflan, MD
Tel Aviv, Israel
Interspecialty Consulting Editors

Jeffrey L. Apfelbaum, MD
Professor and Chair, Department of Anesthesia and Critical Care University of Chicago Pritzker School of Medicine
OFFICIAL PUBLICATION OF THE AMERICAN SOCIETY FOR AESTHETIC PLASTIC SURGERY
A4 Volume 29 Number 3S May/June 2009
CME Information
Dermicol-P35 Collagen: Techniques in Facial and Hand Rejuvenation
Accreditation Statement
This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) and jointly sponsored by the Elsevier Office of Continuing Medical Education (EOCME) and Aesthetic Surgery Journal. The EOCME is accredited by the ACCME to provide continuing medical education (CME) for physicians.
Resolution of Conflict of Interest (COI)

The Elsevier Office of CME has implemented a process to resolve COI for each CME activity. In order to help ensure content objectivity, independence, fair balance, and ensure that the content is aligned with the interest of the public, the EOCME has resolved the conflict by external content review.
Financial Support
The Elsevier Office of CME and Aesthetic Society Journal gratefully acknowledge the educational grant provided by Ortho Dermatologics, Inc.
Credit Designation
The EOCME designates this educational activity for a maximum of 2.5 AMA PRA Category 1 Credit(s). Physicians should only claim credit commensurate with the extent of their participation in the activity.
Intended Audience
This activity is intended for aesthetic and plastic surgeons, dermatologists, and other healthcare professionals involved in providing treatment for the aesthetic needs of patients, with a focus on the face and hands.
Faculty Disclosures
As a sponsor accredited by the ACCME, it is the policy of the EOCME to require the disclosure of anyone who is in a position to control the content of an educational activity. All relevant financial relationships with any commercial interests and/or manufacturers must be disclosed to participants at the beginning of each activity (see table below). The faculty of this CME activity disclose the following:
Goal of the Activity

Loss of structural integrity, elasticity, and regenerative capability of the skin is a consequence of aging, a chronologic and environmental process. These changes often have negative psychological effects, especially in a culture that values youthful appearances. Aesthetic
Nature of Relevant Financial Relationship (Include all those that apply) Faculty Member Robert W Bernard Daniel Cassuto David J Goldberg Christopher Inglefield Marina Landau Laura Palmisano Neil S Sadick Kevin C Smith Commercial Interest Allergan None None None Johnson & Johnson None Johnson & Johnson Johnson & Johnson Consultant For What Role?
Speaker Faculty, Evolence Star Program Grant, Research Support, Consultant, Speaker
Volume 29 Number 3S May/June 2009 S1
replenishment is associated with better work performance and self-esteem. Despite the difficult economy, according to both the American Society for Aesthetic Plastic Surgery and the American Society of Plastic Surgeons, there is a great demand for aesthetic procedures. Dermal fillers have long been recognized as an important tool to address patient needs for both aesthetic enhancements and for soft tissue corrections required as a result of trauma, disease, or congenital defect. This supplement provides an overview of the different types of dermal fillers on the market. It further focuses on the characteristics, utility, and versatility of a new dermal filler, Dermicol-P35. This supplement addresses the unique technical challenges presented by the use of this product in the different regions of the face and hands. Finally, this supplement also provides information on the options available based on the aesthetic structural needs of the patient and the region of the face into which the product is to be injected.
Determine the issues influencing the choice of

dermal filler based on aesthetic structural need and region of the face or hands Identify the technical challenges of injecting dermal fillers into different parts of the face and hands
Unapproved Use Disclosure

The EOCME requires CME faculty to disclose to the participants: 1) When products or procedures being discussed are off-label, unlabeled, experimental, and/or investigational (not US Food and Drug Administration [FDA] approved); and 2) Any limitations on the information that is presented, such as data that are preliminary or that represent ongoing research, interim analyses, and/or unsupported opinion. Faculty may discuss information about pharmaceutical agents that is outside of FDA approved labeling. This information is intended solely for Continuing Medical Education and is not intended to promote off-label use of these medications. If you have questions, contact the medical affairs department of the manufacturer for the most recent prescribing information. We encourage participation by all individuals. If you have any special needs, please contact Craig Smith at 212-462-1933, or c.smith@elsevier.com for assistance. Responses must be submitted by July 30, 2010.
Educational Objectives
Upon completion of this activity, participants will be able to: Discuss the role of dermal fillers in aesthetic and corrective procedures Describe the differences between the 2 major classes of dermal fillers Recognize the unique characteristics of Dermicol-P35
Release date: July 1, 2009 Expiration date: July 30, 2010 Estimated time to complete activity: 2.5 Hours
S2 Volume 29 Number 3S May/June 2009
Introduction
The Science and Technology of Dermicol-P35: Utility and Safety in Aesthetic Procedures
ging is both chronologic and environmental, resulting in skin that increasingly loses structural integrity, elasticity, and regenerative capability.1 In a culture that values a youthful appearance, its loss can often have psychological effects on an individual. Consequently, aesthetic rejuvenation is linked with better self-esteem and work performance.2 From 2006 to 2007, the total number of cosmetic procedures in the United States increased by between 2.4% and 4%.3,4 Injectable medical devices are an important addition to the choices that aesthetic surgeons and dermatologists can offer patients for restoration of a youthful appearance. The ideal characteristics of an injectable medical device for aesthetic use are biocompatibility, a predictably long duration of clinical effect ( 12 months; ie. the retention of 3-dimensional structure at the site of implantation), minimal adverse effects, reduced or no hypersensitivity reaction, and no need for a pretreatment skin test. Dermal fillers fall into 2 main categories, depending on whether they are based on hyaluronic acid (HA) or collagen.5 Constituting approximately 2% of the skin, HA is a glycosaminoglycan polysaccharide with a repeating disaccharide structure and is therefore inherently unlikely to provoke an immune response.6,7 It is also very hygroscopic; dermal fillers that use unmodified HA have a very short lifespan in the body and can be eliminated from the injection site within a week.7 Indeed, the number of HA fillers on the market shows that, while they share basic principles, there are distinctions among them that impact both their utility and their persistence.6,8 Collagens constitute more than 50% of the skin; they are proteins that interact with cells and elements of the extracellular matrix, providing flexibility, elasticity, and strength to the skin.9,10 Collagens can also be customized into various physical forms while retaining their tensile strength, making them a logical choice for use in devices designed to repair, restore, or augment soft tissues, such as the skin. Collagens, being proteins, can be immunogenic and, like those using HA, injectable devices using unmodified collagen are also short-lived.5,11,12
Dr. Bernard is in private practice in White Plains, NY.

Crosslinking is a process that generates bonds between monomeric units, thereby producing a material that has greater viscosity and structural integrity and is more durable.12-14 The first collagen and the current HA devices all use chemicals for crosslinking.11-13,15 However, extensive chemical crosslinking can make the material too rigid and reduce biocompatibility.16 Some concerns have been raised regarding the possibility of delayed adverse immunologic events.17 In addition, it has been suggested that toxicity may be common to all devices using chemical crosslinking because of residual chemicals, leeching, or byproducts.7,18 Devices using crosslinked collagen (eg. CosmoPlast [human; Allergan, Santa Barbara, CA]19 and Zyplast [McGhan Medical Corp., Fremont, CA]11) have been shown to be quite effective and generally safe. However, bovine collagens have a high incidence of allergies and they require a pretreatment skin test20,21 and human collagens have all the safety issues inherent to using allogeneic components. Clinical studies with HA-based dermal fillers (eg. Juvderm [Allergan Inc., Santa Barbara, CA] and Restylane [Medicis Pharmaceutical Corp., Scottsdale, AZ]) show that these implants are effective, exhibit a long duration, and are generally safe,15,22,23 making them the current standard of treatment. Advancements in injectable collagen and crosslinking technologies enabled the development of a new device, Dermicol-P35 (Evolence [Ortho-Dermatologics, Skillman, NJ]), which uses porcine collagen crosslinked through Glymatrix technology.24 This novel process crosslinks collagen fibers using glycation, a natural nonenzymatic reaction that adds sugar moieties to proteins in order to generate intra- and intermolecular bridges.24 Glycation of collagen fibers is associated with increased heat stability and resistance to enzymatic degradation.25 The D-ribose glycation used to crosslink the porcine collagen fibers involved in manufacturing Dermicol-P35 produces a device that has a 3-dimensional structure akin to natural tissue. It is resistant to local enzymatic degradation, while providing an implant that has a highly fibrous network permiting cell implantation, structural and biochemical interaction with the surrounding tissue, and the reconstitution of lost volume.24 Clinical trials with this injectable device have shown its utility for correcting nasolabial folds.24,26 Indeed, DermicolVolume 29 Number 3S May/June 2009 S3
P35 filler exhibits very good clinical performance when directly compared with a bovine collagen dermal filler24 or with an HA dermal filler.26,27 Furthermore, the clinical effects of Dermicol-P35 implants have been shown to persist for at least 12 months, which is as long as HA-based implants.27,28 There do not appear to be any significant adverse events and patients appear to tolerate these implants quite well.24,26,27,29 Finally, unlike devices using bovine collagen, Dermicol-P35 does not appear to require a pretreatment skin test for hypersensitivity,20 thereby allowing a patient immediate access to treatment. It appears that Glymatrix porcine collagen may circumvent the concerns that have been raised regarding chemical crosslinking. In this special supplement to Aesthetic Surgery Journal, practicing aesthetic surgeons and dermatologists provide brief reports on their clinical experiences in the use of DermicolP35 for dermal rejuvenation and/or restoration of the skin in various sites, including acne scars, cheeks, hands, lips, nose, and tear troughs. Although the total number of patients in these studies is small, these reports demonstrate the potentially wide utility and relative safety of this product. In the coming years, as both physicians and patients gain greater experience in the use of this injectable device, we will see more definitively whether Dermicol-P35 lives up to its promising start in the field of dermal filler implants.
ACKNOWLEDGEMENT
Editorial assistance was provided by Mukund Nori, PhD, MBA, of Envision Pharma, Southport, CT.
DISCLOSURES
The author is a consultant for Allergan. An honorarium was offered to Dr. Bernard for his role as Guest Editor of this supplement, but he declined it personally and generously asked that it instead be donated to ASERF.
REFERENCES
1. Makrantonaki E, Zouboulis CC. William J. Cunliffe scientific awards. Characteristics and pathomechanisms of endogenously aged skin. Dermatology 2007;214:352360. 2. Cox SE, Finn JC. Social implications of hyperdynamic facial lines and patient satisfaction outcomes. Int Ophthalmol Clin 2005;45:1324. 3. American Society for Aesthetic Plastic Surgery Web site. Cosmetic surgery national data bank: Statistics. (Accessed 11/10/2008, at http://www.surgery.org/download/2007stats.pdf.) 4. American Society of Plastic Surgeons Web site. 2000/2006/2007 national plastic surgery statistics: Cosmetic and reconstructive procedure trends. (Accessed 12/2/2008, at http://www.plasticsurgery.org/media/statistics/loader.cfm?url /comm onspot/security/getfile.cfm&PageID 29287.) 5. Klein AW. Soft tissue augmentation 2006: Filler fantasy. Dermatol Ther 2006;19:129133. 6. Green MS. Not all hyaluronic acid dermal fillers are equal. Cosmetic Dermatol 2007;20:724729. 7. Tezel A, Fredrickson GH. The science of hyaluronic acid dermal fillers. J Cosmet Laser Ther 2008;10:3542. 8. Rao J, Chi GC, Goldman MP. Clinical comparison between 2 hyaluronic acid-derived fillers in the treatment of nasolabial folds: Hylaform versus Restylane. Dermatol Surg 2005;31:15871590.
9. Cannas M, Bosetti M, Sabbatini M, Ren F. Role of extracellular matrix remodeling in advanced biocompatibility. In: Yaszemski MJ, Trantolo DJ, Lewandrowski K-U, Hasirci V, Altobelli DE, Wise DL, eds. Tissue Engineering and Novel Delivery Systems. New York: Marcel Dekker, Inc.; 2004:130. 10. Leitinger B, Hohenester E. Mammalian collagen receptors. Matrix Biol 2007;26:146155. 11. Klein AW. Collagen substances. Facial Plast Surg Clin North Am 2001;9:205218. 12. Koide T. Designed triple-helical peptides as tools for collagen biochemistry and matrix engineering. Phil Trans R Soc B 2007;362:12811291. 13. Falcone SJ, Berg RA. Crosslinked hyaluronic acid dermal fillers: A comparison of rheological properties. J Biomed Mater Res A 2008;87:264271. 14. Friess W, Schlapp M. Effects of processing conditions on the rheological behavior of collagen dispersions. Eur J Pharm Biopharm 2001;51:259265. 15. Baumann LS, Shamban AT, Lupo MP, et al. Comparison of smooth-gel hyaluronic acid dermal fillers with cross-linked bovine collagen: A multicenter, double-masked, randomized, within-subject study. Dermatol Surg 2007;33(Suppl 2):S128S135. 16. Yang CH. Evaluation of the release rate of bioactive recombinant human epidermal growth factor from crosslinking collagen sponges. J Mater Sci Mater Med 2008;19:14331440. 17. Alijotas-Reig J, Garcia-Gimenez V. Delayed immune-mediated adverse effects related to hyaluronic acid and acrylic hydrogel dermal fillers: Clinical findings, long-term follow-up and review of the literature. J Eur Acad Dermatol Venereol 2008;22:150161. 18. Huang-Lee LL, Cheung DT, Nimni ME. Biochemical changes and cytotoxicity associated with the degradation of polymeric glutaraldehyde derived crosslinks. J Biomed Mater Res 1990;24:11851201. 19. Bauman L. CosmoDerm/CosmoPlast (human bioengineered collagen) for the aging face. Facial Plast Surg 2004;20:125128. 20. Shoshani D, Markovitz E, Cohen Y, Heremans A, Goldlust A. Skin test hypersensitivity study of a crosslinked, porcine collagen implant for aesthetic surgery. Dermatol Surg 2007;33(Suppl 2):S152S158. 21. Soo C, Rahbar G, Moy RL. The immunogenicity of bovine collagen implants. J Dermatol Surg Oncol 1993;19:431434. 22. DeLorenzi C, Weinberg M, Solish N, Swift A. Multicenter study of the efficacy and safety of subcutaneous non-animal-stabilized hyaluronic acid in aesthetic facial contouring: Interim report. Dermatol Surg 2006;32:205211. 23. Schweiger ES, Riddle CC, Tonkovic-Capin V, Aires DJ. Successful treatment with injected hyaluronic acid in a patient with lip asymmetry after surgical correction of cleft lip. Dermatol Surg 2008;34:717719. 24. Monstrey SJ, Pitaru S, Hamdi M, et al. A 2-stage phase I trial of Evolence30 collagen for soft-tissue contour correction. Plast Reconstr Surg 2007;120:303311. 25. Paul RG, Bailey AJ. Glycation of collagen: The basis of its central role in the late complications of ageing and diabetes. Int J Biochem Cell Biol 1996;28:12971310. 26. Narins RS, Brandt FS, Lorenc ZP, et al. A randomized, multicenter study of the safety and efficacy of dermicol-p35 and non-animal-stabilized hyaluronic acid gel for the correction of nasolabial folds. Dermatol Surg 2007;33(Suppl 2):S213S221. 27. Narins RS, Brandt FS, Lorenc ZP, Maas CS, Monheit GD, Smith SR. Twelve-month persistency of a novel ribose-crosslinked collagen dermal filler. Dermatol Surg 2008;34(Suppl 1):S31S39. 28. Pitaru S, Noff M, Blok L, et al. Long-term efficacy of a novel ribosecrosslinked collagen dermal filler: A histologic and histomorphometric study in an animal model. Dermatol Surg 2007;33:10451054. 29. Landau M. Lip augmentation and rejuvenation using a novel, porcine collagen-derived filler. J Drugs Dermatol 2008;7:236240. Copyright 2009 by The American Society for Aesthetic Plastic Surgery, Inc. 1090-820X/$36.00 doi:10.1016/j.asj.2009.01.012
Cheek Augmentation With Dermicol-P35 27G

Neil S. Sadick, MD; and Laura Palmisano, RPA-C
Full and high cheekbones are considered a desirable component of facial attractiveness. The aging process can result in a loss of facial volume and changes in facial contours. Cheek augmentation can replace lost facial volume, rejuvenate facial appearance, enhance cheek prominence, and improve facial symmetry. A new, highly purified, porcine-based collagen filler Dermicol-P35 #27G (Evolence; Ortho Dermatologics, Skillman, NJ) is now available that does not require pretreatment sensitivity testing and has shown a 12-month persistence of results in clinical trials. This article discusses the clinical experience of patients who received cheek augmentation with Dermicol-P35. ( (Aesthetic Surg J 2009;29:S5S8.)
ull and high cheek bones are considered highly desirable for facial attractiveness and are associated with youth.1 During the aging process, the soft tissues of the face can suffer a loss of volume when subcutaneous fat redistributes or diminishes.2 Factors that can contribute to facial aging include diminished tissue elasticity, gravity, stress, and sun exposure.2 Cheek (malar) augmentation is a very popular procedure that can replace lost facial volume, enhance cheek prominence, improve facial symmetry, and restore a youthful appearance. Surgical procedures to enhance the cheek area include permanent implantation of materials such as silicone.3 However, there are several disadvantages to permanent implants, including the invasiveness of the procedure, infection, the potential displacement of implants, and the loss of sensation to the area.4 Therefore, for many patients who are seeking an effective procedure to enhance their malar region but who also want to avoid the potential problems of surgery, a minimally invasive, nonsurgical procedure is preferable. Nonsurgical options for soft tissue contouring include autologous fat injections (which require a separate preliminary harvesting procedure)5 and injectable dermal fillers. Dermal fillers in particular have become increasingly popular among both patients and clinicians because they can be used to restore volume and rejuvenate facial appearance with minimal discomfort to the patient.6 The ideal dermal filler should be safe and nonpermanent, but last 1 to 2 years, have low immunogenicity and low incidence of adverse events, be easy to inject, and cause minimal pain upon injection.7 Currently, there exist many dermal filler options, which can differ in material origin (biologic or synthetic) and longevity in the body (biodegradable or permanent).8 Biodegradable fillers include hyaluronic acid-based and collagen-based fillers, both of which range in longevity from 3 months to 1 year,5 and calcium hydroxylapatite9
Dr. Sadick is in private practice in New York, NY.

(Radiesse/Radiance FN; BioForm Medical, San Mateo, CA) and poly-L-lactic acid (Sculptra; Dermik Laboratories, Bridgewater, NJ), both of which can last up to 2 years. Permanent fillers (including polymethylmethacrylate and silicone) can be difficult to remove and may be associated with a higher incidence of late complications, such as inflammatory nodules, vascular occlusion, and granulomas.5,10-12 Therefore, biodegradable fillers may be a better option for some patients, such as those receiving treatment for the first time.5 Injectable bovine collagen-derived dermal fillers (Zyderm and Zyplast; Allergan, Santa Barbara, CA) have been available for use in the correction of facial contour defects since the 1980s.13 However, this material has been associated with sensitivity in some patients and therefore requires a skin test 4 weeks before treatment.5,8 In addition, this material generally provides shorter-term results (3-5 months) compared with newer dermal fillers and it uses glutaraldehyde as a crosslinking molecule.5,14 Human collagen-based dermal fillers (Cosmoderm and Cosmoplast; Inamed) are also available. These fillers do not require a skin test, but results from these products are also shorter-term (3-5 months).5 Hyaluronic acid-based dermal fillers (including Restylane and Perlane [Medicis Aesthetics, Scottsdale, AZ] and Juvderm [Allergan, Santa Barbara, CA]) do not require a pretreatment skin test and provide longerlasting results compared with bovine collagenbased dermal fillers. In one clinical study, smooth gel hyaluronic acid dermal filler (Juvderm) showed an improved persistence of results (>6 months) compared with a bovine collagen-based dermal filler and was preferred by the majority of treated patients.15 For Restylane SubQ, beneficial results were reported to persist up to 64 weeks in patients who received cheek augmentation.16 However, a 2007 study by Alijotas-Reig et al17 reported that hyaluronic acid-based fillers may be associated with chronic inflammatory and granulomatous adverse reactions.
Recently, a new, highly purified, crosslinked, porcine collagen-derived dermal filler Dermicol-P35 27G (Evolence [Ortho Dermatologics, Skillman, NJ]) has become available. This filler is produced using Glymatrix technology, a novel method of crosslinking collagen molecules using a natural sugar, D-ribose.18 Dermicol-P35 27G has proven efficacious for the treatment of nasolabial folds, with results persisting for at least 12 months.18,19 Low immunogenicity was also reported; therefore, a skin test is not required before the procedure. Here we discuss our clinical experience with Dermicol-P35 27G in patients who received cheek augmentation.
RESULTS
The typical volumes of Dermicol-P35 27G administered for cheek augmentation are 1 mL (1 full syringe) per cheek, but some patients may require more. The results are immediately visible to patients after injection. The majority of patients experience little or no recovery time and are able to resume their normal activities immediately after the procedure. For the majority of patients, full correction is achieved in 1 visit. In our clinical practice, patients have reported that the Dermicol-P35 27G injection may be more painful than other fillers. However, generally, minimal or no swelling or bruising is observed postinjection and at the first follow-up visit. Patient satisfaction has been very high and patients return for further treatments every 3 to 6 months to maintain their results. Unlike results seen with some hyaluronic acid fillers, which can swell,20 we have not encountered any cases of overcorrection with Dermicol-P35 27G.
MATERIALS AND METHODS

Dermicol-P35 27G is suitable for patients desiring mild to moderate cheek correction and is supplied in a sterile, prefilled, 1-mL syringe with a 27-gauge needle (with either an 0.5- or 1-inch needle). For some patients, injection with a 30-gauge needle is preferable. Patients who are prone to bruising are instructed to avoid aspirin and nonsteroidal antiinflammatory drugs for 1 week prior to treatment. Before treatment, our patients were photographed and patient consent was collected. To increase patient comfort during injection, either a topical anesthetic (such as lidocaine) was applied to the injection site 30 minutes before injection or 0.2 mL of lidocaine was mixed into the syringe. Injection sites were marked and the treatment area was cleaned with a topical antiseptic. The needle was inserted in 3 locations where the tear trough meets the zygomatic arch. The sites of injection for cheek augmentation are shown in Figure 1. The filler was injected in a retrograde fashion transdermally into the mid-to-deep dermal layer (Figure 2) to provide structural support. Injection techniques comprised a combination of linear threading and vertical and horizontal crosshatching. Once the treatment was complete, the cheek areas were slightly massaged and ice was applied if necessary. Patients were instructed to apply ice if swelling occurred and not to manipulate the area for several hours. Patients were evaluated immediately after injection and 1 week posttreatment.
Mid-pupil
Case Report
A 37-year-old woman presented with mild volume loss and desired a fuller, more youthful appearance to her face (Figure 3, A, C). One milliliter of filler was injected C into each cheek. She also elected to have filler injected into her chin. No swelling, bruising, or lumps were observed 1 hour posttreatment (Figure 3, B, D). After treatment, her cheeks appeared fuller and more prominent and her overall appearance was more youthful.
DISCUSSION
Sagging skin and the loss of facial fullness are common consequences of the aging process. Biodegradable dermal fillers provide a practical, convenient, and effective alternative to surgical cheek augmentation.21 To reduce the signs of facial aging, dermal fillers can replace subdermal malar fat, restore facial volume, and smooth the appearance of facial skin. Dermicol-P35 27G is a new, porcine collagen-derived biodegradable dermal filler that has shown high patient satisfaction and superior durability compared with bovine collagen filler in clinical trials.18 In addition, lower incidences of bruising and swelling have been reported with porcine collagen dermal filler injection compared with hyaluronic acid-based fillers.22
Zygomatic Arch
Tear trough
Dermicol-P35 27G
Injection sites
Figure 1. Diagram of injection sites for cheek augmentation.
Figure 2. Placement of Dermicol-P35 27G within the dermal layer for cheek augmentation.
Figure 3. A, C, Pretreatment views of a 37-year-old woman. B, D, Posttreatment view 1 hour after treatment with Dermicol-P35 27G (total injection of 1 mL per cheek).
Our clinical experience with Dermicol-P35 27G for the purpose of cheek augmentation has been highly favorable. We have found that Dermicol-P35 27G demonstrates good tolerability, reproducible effects, and less bruising and swelling than other dermal fillers. Over the past year, our clinical results have been consistent with the results previously reported for Dermicol-P35 27G and our patients have consistently reported high satisfaction with their aesthetic outcomes. Because of their satisfaction with DermicolP35 27G, some patients have requested additional treatment after 3 to 6 months to further augment or enhance the prominence of their cheek region. Patients desiring maintenance treatment generally return after 6 or more months.
mentation. We have found that patients who have undergone cheek augmentation with Dermicol-P35 27G report minimal recovery time, a low incidence of adverse events, little to no swelling or bruising immediately postinjection, and high satisfaction with their results. Therefore, Dermicol-P35 27G is a convenient and tolerable option for patients seeking to restore facial volume and improve facial contours with a temporary dermal filler.
ACKNOWLEDGMENT
The authors would like to acknowledge the assistance of Rebecca Jarvis, PhD, of Envision Pharma (Southport, CT) in the preparation of this manuscript.
CONCLUSION
Dermicol-P35 27G is a newly available porcine collagen-based dermal filler for use in facial contour augCheek Augmentation With Dermicol-P35 27G
DISCLOSURES
The author is a faculty member of the Evolence STAR Program and Colbar LifeSciences.
REFERENCES
1. Sito G. Transoral injection of Restylane SubQ for aesthetic contouring of the cheeks. Aesthetic Surg J 2006;26(Suppl 1):S22S27. 2. Coleman S, Grover R. The anatomy of the aging face: Volume loss and changes in 3-dimensional topography. Aesthetic Surg J 2006;26(Suppl 1):S4S9. 3. Ivy EJ, Lorenc ZP, Aston SJ. Malar augmentation with silicone implants. Plast Reconstr Surg 1995;96:6368. 4. The American Society for Aesthetic Plastic Surgery Web site. Cheek augmentation. (Available at http://www.surgery.org/public/ procedures/cheek_augmentation, accessed 12/7/2008.) 5. Narins RS, Bowman PH. Injectable skin fillers. Clin Plast Surg 2005;32:151162. 6. Busso M. Soft tissue augmentation: Nonsurgical approaches to treatment of the mid and lower facial regions. Dermatol Nurs 2008;20:211214, 217219. 7. Tezel A, Fredrickson GH. The science of hyaluronic acid dermal fillers. J Cosmet Laser Ther 2008;10:3542. 8. Cirillo P, Benci M, Bartoletti E, Bertana C. Proposed guidelines for use of dermal and subdermal fillers. G Ital Dermatol Venereol 2008;143:187193. 9. Sklar JA, White SM. Radiance FN: A new soft tissue filler. Dermatol Surg 2004;30:764768. 10. Salles AG, Lotierzo PH, Gemperli R, et al. Complications after polymethylmethacrylate injections: Report of 32 cases. Plast Reconstr Surg 2008;121:18111820. 11. Bagal A, Dahiya R, Tsai V, Adamson PA. Clinical experience with polymethylmethacrylate microspheres (Artecoll) for soft-tissue augmentation: A retrospective review. Arch Facial Plast Surg 2007;9:275280. 12. Vedamurthy M. Standard guidelines for the use of dermal fillers. Indian J Dermatol Venereol Leprol 2008;74(Suppl):S23S27. 13. Cooperman LS, Mackinnon V, Bechler G, Pharriss BB. Injectable collagen: A six-year clinical investigation. Aesthetic Plast Surg 1985;9:145151. 14. Klein AW. Collagen substances. Facial Plast Surg Clin North Am 2001;9:205218. 15. Baumann LS, Shamban AT, Lupo MP, et al. Comparison of smooth-gel hyaluronic acid dermal fillers with crosslinked bovine collagen: A multicenter, double-masked, randomized, within-subject study. Dermatol Surg 2007;33(Suppl 2):S128S135. 16. Lowe NJ, Grover R. Injectable hyaluronic acid implant for malar and mental enhancement. Dermatol Surg 2006;32:881885. 17. Alijotas-Reig J, Garcia-Gimenez V. Delayed immune-mediated adverse effects related to hyaluronic acid and acrylic hydrogel dermal fillers: Clinical findings, long-term follow-up and review of the literature. J Eur Acad Dermatol Venereol 2008;22:150161. 18. Monstrey SJ, Pitaru S, Hamdi M, et al. A two-stage phase I trial of Evolence30 collagen for soft-tissue contour correction. Plast Reconstr Surg 2007;120:303311. 19. Narins RS, Brandt FS, Lorenc ZP, Maas CS, Monheit GD, Smith SR. Twelve-month persistency of a novel ribose-cross-linked collagen dermal filler. Dermatol Surg 2008;34(Suppl 1):S31S39. 20. Belmontesi M, Grover R, Verpaele A. Transdermal injection of Restylane SubQ for aesthetic contouring of the cheeks, chin, and mandible. Aesthetic Surg J 2006;26(Suppl 1):S28S34. 21. Carruthers JD, Carruthers A. Facial sculpting and tissue augmentation. Dermatol Surg 2005;31(11 Part 2):16041612. 22. Narins RS, Brandt FS, Lorenc ZP, et al. A randomized, multicenter study of the safety and efficacy of Dermicol-P35 and non-animal-stabilized hyaluronic acid gel for the correction of nasolabial folds. Dermatol Surg 2007;33(Suppl 2):S213S221. Accepted for publication March 6, 2009. Reprint requests: Neil S. Sadick, MD, FAAD, FACS, Sadick Dermatology, New York, NY 10075. E-mail: nssderm@sadickdermatology.com. Copyright 2009 by The American Society for Aesthetic Plastic Surgery, Inc. 1090-820X/$36.00 doi:10.1016/j.asj.2009.03.004
Correction of Tear Trough Deformity With Novel Porcine Collagen Dermal Filler (Dermicol-P35)
David J. Goldberg, MD, JD
Deformity of the tear trough region, which can occur during the aging process, can result in dark shadows under the eyes and a fatigued appearance. Augmentation of the tear trough is challenging because of the thin skin and lack of fat in the region. Adding volume to the tear trough region with a dermal filler is a nonsurgical procedure with minimal discomfort to the patient. Dermicol-P35 (Evolence; Ortho Dermatologics, Skillman, NJ) is a new, ribose crosslinked, highly purified, porcine-based collagen filler that does not require prior skin testing and has shown improved persistence compared with bovine collagen-based dermal fillers. In this article, we present the clinical outcomes of patients who have received treatment with a novel ribose crosslinked porcine collagen dermal filler for the correction of tear trough deformity. (Aesthetic Surg J 2009;29:S9S11.) (
he loss of volume in the face and the anterior displacement of the infraorbital fat, primarily caused by the aging process, can lead to an unsightly depression in the suborbital region known as the tear trough.1,2 The tear trough has been defined as the hollow of the medial lower eyelid, bordered by the anterior lacrimal crest and the inferior orbital rim.3,4 Tear trough deformity can result in dark shadows under the eyes and a fatigued appearance.3 The correction of tear trough deformity can be challenging because the skin in this region lacks fat and thins with age. The proximity of the tear troughs to the eyes is also a concern.2 Swelling and, rarely, blindness from intraarterial injections are concerns when treating the tear trough.5,6 Options for tear trough augmentation have included both surgical (blepharoplasty) and nonsurgical methods, such as injection of either autologous fat or one of the currently available dermal fillers. While surgery can be successful, it is also very invasive, has a long recovery time, and is subject to a higher risk of complications than dermal fillers.5 The injection of autologous fat, while less prone to immune responses, requires harvesting this tissue from the patient, often requires a long time for recovery, and may produce results that are lumpy.5,6 The use of a dermal filler to correct tear trough deformity is minimally invasive and causes much less discomfort to the patient than a surgical procedure. While dermal fillers do not address the underlying causes of the tear trough deformity, they can restore volume and provide a smoother and more even appearance to the region. Permanent dermal fillers that are not biodegradable (eg. silicone and polymethylmethacrylate) are not recommended
Dr. Goldberg is in private practice in New York, NY.

for use in the tear trough region because they are microsphere-based and may cause clumping.2 Several biodegradable dermal fillers, which can be classified as semipermanent or temporary, are available for use in tear trough augmentation.7 Semipermanent options, which can last for 1 to 2 years, include calcium hydroxylapatite (Radiesse/Radiance FN; BioForm Medical, San Mateo, CA) and poly-L-lactic acid (Sculptra; Dermik Laboratories, Bridgewater, NJ). Temporary dermal fillers can be either hyaluronic acid (HA)-based (Restylane [Medicis Aesthetics, Scottsdale, AZ] and Juvderm [Allergan, Santa Barbara, CA]) or collagen-based (Zyderm and Zyplast [Allergan, Santa Barbara, CA], and DermicolP35 [Ortho Dermatologics, Skillman, NJ]. Favorable results have been reported with the use of HA-based dermal fillers in tear trough correction.5 One potential disadvantage that has been reported with HAbased dermal fillers is the Tyndall effect, characterized by a bluish-gray discoloration that can result from excessively superficial placement of the filler.8,9 Bovine collagen based dermal fillers such as Zyderm and Zyplast have also been used in this region, but these dermal fillers generally have a shorter duration of effect compared with HA-based fillers.7 Localized hypersensitivity has been associated with bovine collagenbased dermal fillers,10 requiring a skin test 4 weeks before the procedure.11 Dermicol-P35 is a new, highly purified, porcine-based collagen dermal filler that produced by a novel crosslinking of collagen molecules using a natural sugar, D-ribose.12 Clinical studies have found that Dermicol-P35 demonstrated comparable efficacy for treating nasolabial folds to bovine collagenbased and HA-based products.12,13 Dermicol-P35 has also demonstrated persistence for up to 12 months and low immunogenicity.12 A skin test is therefore not required before the procedure. In this article, we
A 30-gauge needle allowed for more careful placement of dermal filler with less trauma to the thin-skinned tear trough region. Dermal filler material was injected in a retrograde fashion, wherein the needle is slowly withdrawn as the material is injected. This allowed the majority of the filler material to be injected at the periosteum, with small amounts being injected in the subcutaneous and dermal level. Such an approach provided for a blending and softening of the clinical appearance. Magnifier/polarizing lenses were worn by the injecting physician in an attempt to avoid vessels and thereby lessen the likelihood of injectioninduced ecchymosis. The area was gently massaged after injection and cold compresses were applied to the area for 5 minutes after the procedure. All subjects were followed for 3 months after treatment and evaluated for both clinical effect and complications.
RESULTS
A total of 10 female patients were treated for tear trough deformities with Dermicol-P35. Patients ranged in age from 30 to 60 years. No patients had received any previous tear trough treatments. Average total injected volumes of dermal filler ranged from 0.3 to 0.6 mL. All patients were noted to have excellent clinical results. No swelling or lumpiness was observed after treatment. Few adverse events were reported; only 1 subject was noted to have any posttreatment ecchymoses. Additionally, no Tyndall effect was noted. All patients were able to resume normal work and social activities immediately after treatment. At the 3-month follow-up visit, treatment results were persistent and patient satisfaction was high. In addition, no complications were reported at this visit.
Patients
Patient 1. A 31-year-old female patient presented with mild tear trough deformities and lower eyelid hyperpigmentation (Figure 1,A). No swelling or lumpiness was observed 1 day after treatment (Figure 1,B). After 3 months, the appearance of the tear troughs was greatly improved and the appearance of undereye shadows was diminished (Figure 1,C). C Patient 2. A 55-year-old female patient showed tear trough deformity, with a thinned appearance to the lower eyelid skin and small angioma on the lower eyelid skin as well (Figure 2,A). After 3 months, the quality of the lower eyelid skin was greatly improved and partial hiding of the vascular lesion was also achieved (Figure 2,B).
C
Figure 1. A, Pretreatment view of a 31-year-old woman. B, Posttreatment view 1 day after porcine collagen injection. C, Posttreatment view 3 months after Dermicol-P35 injection.
present the clinical experience and outcomes of patients who have received treatment with Dermicol-P35 (Evolence) for the correction of tear trough deformity.
MATERIALS AND METHODS

Female patients presenting with tear trough deformities were injected with porcine collagen dermal filler. Subjects were excluded if they had previous eyelid surgery or a history of atopic dermatitis because patients with this condition are highly susceptible to inflammatory responses (eg. inflammation of the lower eyelid). After photographic documentation and informed consent, topical anesthetic was applied for 30 minutes before treatment. Dermicol-P35 (Evolence) was injected with a 30gauge needle, predominantly at the level of the periosteum. S10 Volume 29 Number 3S May/June 2009
DISCUSSION
Treatment with Dermicol-P35 (Evolence) injection improved the appearance of tear trough deformity and reduced hyperpigmentation in all 10 treated patients. Unlike the results reported with both autologous fat injections and permanent dermal fillers,6 porcine collagen filler produced smooth and even results. Adverse events and recovery periods were minimal and all patients were able to resume normal activities immediately after treatment. These results are consistent with previous studies.13 Lastly, treatment effects
Figure 2. A, Pretreatment view of a 55-year-old woman. B, Posttreatment view 3 months after porcine collagen injection.
were found to persist for at least 3 months and all patients reported high satisfaction with their results. Tear trough deformities caused by aging can result in unsightly dark shadows under the eyes and a tired appearance. Many patients elect to treat tear trough deformities to restore a youthful appearance. While surgical treatments are available, surgery is invasive, can require a lengthy recovery period, and has a higher risk of complications.6,14 Conversely, temporary dermal fillers offer a minimally invasive and nonsurgical method to improve the appearance of tear trough deformities with minimal discomfort and recovery time. They can restore volume to the region, improve the appearance of hyperpigmentation, and rejuvenate the facial appearance when combined with a good injection technique.
CONCLUSION
Dermicol-P35 (Evolence) is a new dermal filler that is available for use in nonsurgical soft tissue augmentation. The results from these 10 treated patients indicate that DermicolP35 injection provides a convenient, effective, and minimally invasive option for the correction of tear trough deformities. Patients experienced minimal adverse events and reported high levels of satisfaction with their results.
ACKNOWLEDGMENTS
The author would like to acknowledge the assistance of Rebecca Jarvis, PhD, of Envision Pharma (Southport, CT) in the preparation of this manuscript.
2. Busso M. Soft tissue augmentation: Nonsurgical approaches to treatment of the mid and lower facial regions. Dermatol Nurs 2008;20:211214, 217219. 3. Sadick NS, Bosniak SL, Cantisano-Zilkha M, Glavas IP, Roy D. Definition of the tear trough and the tear trough rating scale. J Cosmet Dermatol 2007;6:218222. 4. Bosniak S, Cantisano-Zilkha M, Purewal BK, Torres JJ, Rubin M, Remington K. Defining the tear trough. Ophthal Plast Reconstr Surg 2007;23:254255. 5. Kane MA. Treatment of tear trough deformity and lower lid bowing with injectable hyaluronic acid. Aesthetic Plast Surg 2005;29:363367. 6. Lambros VS. Hyaluronic acid injections for correction of the tear trough deformity. Plast Reconstr Surg 2007;120(6 Suppl):74S80S. 7. Vedamurthy M. Standard guidelines for the use of dermal fillers. Indian J Dermatol Venereol Leprol 2008;74(Suppl):S23S27. 8. Douse-Dean T, Jacob CI. Fast and easy treatment for reduction of the Tyndall effect secondary to cosmetic use of hyaluronic acid. J Drugs Dermatol 2008;7:281283. 9. Hirsch RJ, Narurkar V, Carruthers J. Management of injected hyaluronic acid induced Tyndall effects. Lasers Surg Med 2006;38:202204. 10. Keefe J, Wauk L, Chu S, DeLustro F. Clinical use of injectable bovine collagen: A decade of experience. Clin Mater 1992;9:155162. 11. Zyderm (bovine collagen implant) [package insert]. Fremont, CA: McGhan Medical Corp; 2000. 12. Monstrey SJ, Pitaru S, Hamdi M, et al. A two-stage phase I trial of Evolence30 collagen for soft-tissue contour correction. Plast Reconstr Surg 2007;120:303311. 13. Narins RS, Brandt FS, Lorenc ZP, Maas CS, Monheit GD, Smith SR. Twelve-month persistency of a novel ribose-crosslinked collagen dermal filler. Dermatol Surg 2008;34(Suppl 1):S31S39. 14. Spector JA, Draper L, Aston SJ. Lower lid deformity secondary to autogenous fat transfer: A cautionary tale. Aesthetic Plast Surg 2008;32:411414. Accepted for publication February 27, 2009. Reprint requests: David J. Goldberg, MD, JD, FAAD, Skin Laser and Surgery Specialists of New York and New Jersey, 115 E. 57th St., Ste. 710, New York, NY 10022-2184. E-mail: drdavidgoldberg@skinandlasers.com. Copyright 2009 by The American Society for Aesthetic Plastic Surgery, Inc. 1090-820X/$36.00 doi:10.1016/j.asj.2009.02.013
DISCLOSURES
The author has no financial interest in products mentioned in this article.
REFERENCES
1. Coleman SR, Grover R. The anatomy of the aging face: Volume loss and changes in 3-dimensional topography. Aesthetic Surg J 2006;26(Suppl 1):S4S9. Correction of Tear Trough Deformity With Novel Porcine Collagen Dermal Filler
Lip Augmentation and Rejuvenation Using Dermicol-P35 30G: Personal Experiences From My Clinic
Marina Landau, MD
Predictable changes in the lips caused by aging often prompt women to seek lip augmentation and/or rejuvenation. This article describes the clinical experience of patients who underwent lip augmentation and rejuvenation procedures using Dermicol-P35 30G (Evolence Breeze; Ortho Dermatologics, Skillman, NJ) a novel, Dribose cross-linked, porcine collagen dermal filler. The majority of patients reported that the improvement afforded by Dermicol-P35 30G was either good or very good 3 months after their procedure, with minimal adverse effects. (Aesthetic Surg J 2009;29:S12S15.) (
lthough a universal definition describing an ideal pair of lips does not exist, a pair of proportionally projecting feminine lips is generally considered to be sexually attractive.1 As one ages, the lips are inevitably subjected to predictable physical changes that often prompt women to seek lip augmentation and/or rejuvenation in an attempt to improve their appearance. Lip augmentation can be loosely defined as a procedure to enhance the fullness of lips. Lip rejuvenation refers to a procedure for the correction of lip lines, restoration of the contour and buttresses, and redirection of the drooping angles of the lips, all with the aim of reversing the changes associated with aging. In recent years, an increasing number of interventions have been introduced that seek to improve the appearance of the lips. These include tissue or autologous fat grafts, alloplastic implants, and surgical procedures on lip mucosa. The use of injectable fillers is the most common technique for lip shape and volume enhancement. Two of the more popular injectable fillers are made from hyaluronic acid (HA) or collagen, both of which are natural constituents of the normal dermis.2 Collagen was one of the first fillers for aesthetic enhancement and has been in use for more than 20 years. The results of lip shaping by collagen have always been highly appreciated aesthetically. However, because of the relatively short longevity of the results, the early injectable collagen devices have been replaced by HAbased fillers for this indication. In its pure form, HA is a naturally occurring linear polysaccharide with a low risk of immunogenicity because of its lack of species or tissue specificity. Studies on nonanimal, stabilized HA devices
such as Restylane (Medicis Pharmaceutical Corp., Scottsdale, AZ) have shown favorable efficacy results and a low incidence of adverse events following injection.3,4 However, HA fillers are hygroscopic and these procedures on the lips are inevitably accompanied by bruising and swelling. More recent studies have also raised concerns over delayed adverse events relating to HA.5,6 Dermicol-P35 (Evolence; Ortho Dermatologics, Skillman, NJ) is a suspension of crosslinked, fibrillar type I collagen isolated from porcine tendons. DermicolP35 is considered more human-like and has not been associated with the same degree of immunogenicity as bovine collagen.7 The inter- and intramolecular crosslinking of collagen fibers in Dermicol-P35 fillers is produced via D-ribose glycation, a naturally occurring nonenzymatic series of reactions between sugars and proteins. This results in a product that exceeds the clinical performance of previous collagen-based devices and includes advantages such as longevity, low immunogenicity, easy injectability, natural-appearing results, and a lower rate of postinjection swelling and bruising.8 Dermicol-P35 30G is a newer formulation containing shorter collagen fibers that allow the product to flow through a smaller needle lumen. The major practical difference between the 2 products is that Dermicol-P35 27G is delivered through a 27-gauge needle, while DermicolP35 30G is delivered through a 30-gauge needle. This article focuses on the authors clinical experience with patients who underwent lip augmentation and rejuvenation procedures using Dermicol-P35 30G.
PATIENTS AND PROCEDURES

Lip augmentation and rejuvenation procedures using Dermicol-P35 30G were performed on 15 patients
From the Dermatology Unit, Wolfson Medical Center, Holon, Israel.
Table. Patient demographics and satisfaction after procedure Patient no. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

F F, Female.
Patient satisfaction Touch-up at 3 months in 2 weeks Very good Very good Good Very good Very good Very good Good Good Satisfactory Very good Good Very good Good Satisfactory Very good + + +
Amount of filler, mL 1.0 1.5 1.0 2.0 2.0 1.2 2.0 1.0 1.0 2.2 1.0 1.0 1.4 1.2 1.8
Nasolabial correction + + + + + +
Indication Augmentation Rejuvenation Rejuvenation Rejuvenation Rejuvenation Augmentation Rejuvenation Augmentation Augmentation Rejuvenation Rejuvenation Rejuvenation Augmentation Augmentation Rejuvenation
Age, y 42 57 60 55 55 47 59 43 44 61 58 57 44 47 56
Sex F F F F F F F F F F F F F F F
(Table). The use of any anticoagulant or antiplatelet medication was prohibited before the procedures. Oral acyclovir (400 mg twice daily for 5 days) was administered to those with a previous history of herpes labialis. A thorough assessment of lip shape, volume, and condition was performed before Dermicol-P35 30G injection. The initial stages of the procedures on lips were performed under local anesthesia because the lips are one of the most sensitive areas of the face. DermicolP35 30G was mixed with a local anesthetic (0.3 mL lidocaine 1%) to render the injections more tolerable to patients. The mixture was performed through a commercially available female-to-female connector under strict aseptic conditions. The results were assessed immediately after the procedure, after 2 to 3 weeks, and after 3 months. Adverse events were assessed by the physician up to 6 months after the procedure.
mal amount of filler (1 mL) required a touch-up 2 weeks after the procedure. The addition of 0.3 mL lidocaine 1% did not affect the longevity or the efficacy of Dermicol-P35 30G. Contrary to cases where topical or regional pretreatment anesthesia was used, no distortion of the lip shape and volume occurred. Because swelling was minimal during the injection, the final result was more visible and could be more easily appreciated by the physician and the patient. In contrast to our previous experience with HA-based dermal fillers, only minimal swelling on the lips was noted after injection with Dermicol-P35 30G. Transient lumps on the lips were reported, but spontaneously cleared within 4 weeks after the procedure.
Patients
Patient 1. A 47-year-old woman (Figure 1) was injected with 1.2 mL of Dermicol-P35 30G into the lower and upper lips in order to enhance their volume and to correct the slight asymmetry in the shape of the right part of the lower lip. Immediate results were obtained, where more symmetric and pleasantly plump lips were observed. No swelling or bruising was noted. Patient 2. A 42-year-old woman presented with an unsatisfactory appearance in the shape of her lips, mainly because of the upper lip, which lacked volume. Lip augmentation to correct the volume and redefine the vermillion border of the lip was performed with 1.0 mL of Dermicol-P35 30G. A comparison made on photographs taken before and after the procedure (Figure 2) shows that the philtral columns were successfully reconstructed, which makes the upper lip look pleasantly shorter.
RESULTS
As we have previously reported, 15 patients were included in the study.9 All of the patients were women, with a mean age of 52.3 years (range 42-61 years). Nine patients underwent lip rejuvenation (with or without correction of the nasolabial folds) and 6 patients underwent lip augmentation (with or without correction of the nasolabial folds; Table). The mean amount of Dermicol-P35 30G used per patient was 1.4 mL (range 1.0-2.2 mL). Three months after the procedures, 13 patients (86.7%) reported that the improvement afforded by Dermicol-P35 30G was either good or very good and 2 patients (13.3%) reported that the improvement was satisfactory. Only 3 patients who initially received a miniLip Augmentation and Rejuvenation Using Dermicol-P35 30 G
Figure 1. Patient 1. A, Pretreatment view of a 47-year-old woman. B, Posttreatment view immediately after the injection of 1.2 mL of DermicolP35 30G into the lower and upper lips.
Figure 2. A, Pretreatment view of a 42-year-old woman. B, Posttreatment view 2 weeks after the injection of 1.0 mL of Dermicol-P35 30G into the upper lip.
Patient 3. A 57-year-old patient with upper lip wrinkles and blurred vermilion border of both lips was injected with 1.0 mL of Dermicol-P35 30G. Three months after the procedure, an almost absolute disappearance of the wrinkles was noted. The postprocedure photograph clearly shows that a redefinition of the vermilion border rejuvenated the patients appearance.
DISCUSSION
Injectable fillers for dermal contour corrections originated with the introduction of Zyderm and Zyplast (McGhan Medical Corp., Fremont, CA)10 injectable bovine collagen in the United States in 1981.9 These agents opened up the possibilities for lip augmentation and rejuvenation to create a fuller appearance. Since the mid-1990s, HA-based fillers have provided an additional option to the physician. As mentioned above, the continuing use of HAbased fillers, especially on the lips, is limited by the bruising and swelling that occur after injection. S14 Volume 29 Number 3S May/June 2009
The ideal injectable filler for immediate correction is characterized by a long-term persistency and a low occurrence of adverse events or complications.11 The use of bovine injectable collagens was limited because of the high incidence of allergies and the need for a pretreatment skin test, as well as their limited duration of clinical contour correction. Although human-sourced collagens such as CosmoDerm and CosmoPlast (Allergan, Santa Barbara, CA) may circumvent the need for skin tests, the use of glutaraldehyde-based crosslinking technology limits the extent of crosslinking that can be achieved and the nature of the crosslinks formed.11,12 The deficiencies of earlier collagen-based fillers are mostly resolved by the introduction of Dermicol-P35 filler. The inter- and intramolecular cross-linking of collagen fibers in Dermicol-P35 filler are generated via glycation, which results in a product that is resistant to local enzymatic degradation.12 In addition, a pretreatment skin test is unnecessary and the occurrence of
Figure 3. Patient 3. A, Pretreatment view of a 57-year-old woman. B, Posttreatment view 3 months after the injection of 1.0 mL of Dermicol-P35 30G into both lips.
hypersensitivity is minimal.13 The sugar-based crosslinkers used to produce Dermicol-P35 also result in a structure with enhanced integrity and strength, which could lead to higher persistency in areas that are subjected to corrections. Based on the experience garnered during this study, Dermicol-P35 30G was found to be especially efficient in the treatment of small upper lip wrinkles (Figure 3). Our experience has shown that these wrinkles are extremely challenging and cannot be efficiently eliminated using HA-based fillers without some swelling of the upper lip skin or linear ridges along the injection lines. On the contrary, the use of Dermicol-P35 30G in the lip region produced relatively minimal swelling and bruising. This rendered the procedure more acceptable and the immediate results could be more easily appreciated. The longevity of the results in the lips was another important advantage of this filler. The advantages of Dermicol-P35 when compared with previous collagen-based fillers were successfully shown in clinical trials.8 The satisfaction expressed by the majority of patients in this study further supported the remarkable effectiveness and safety of Dermicol-P35 30G when used in lip augmentation and rejuvenation procedures.
REFERENCES
1. Sutter RE Jr, Turley PK. Soft tissue evaluation of contemporary Caucasian and African American female facial profiles. Angle Orthod 1998;68:487496. 2. Carruthers JD, Glogau RG, Blitzer A, Facial Aesthetics Consensus Group Faculty. Advances in facial rejuvenation: Botulinum toxin type A, hyaluronic acid dermal fillers, and combination therapiesconsensus recommendations. Plast Reconstr Surg 2008;121(5 Suppl):5S30S. 3. Olenius M. The first clinical study using a new biodegradable implant for the treatment of lips, wrinkles, and folds. Aesthetic Plast Surg 1998;22:97101. 4. Duranti F, Salti G, Bovani B, Calandra M, Rosati ML. Injectable hyaluronic acid gel for soft tissue augmentation. A clinical and histological study. Dermatol Surg 1998;24:13171325. 5. Lowe NJ, Maxwell CA, Lowe P, Duick MG, Shah K. Hyaluronic acid skin fillers: Adverse reactions and skin testing. J Am Acad Dermatol 2001;45:930933. 6. Lupton JR, Alster TS. Cutaneous hypersensitivity reaction to injectable hyaluronic acid gel. Dermatol Surg 2000;26:135137. 7. Nir E, Goldlust A, Shoshani D, Azachi M. Long-term in vivo evaluation of the safety and efficacy of a new porcine collagen dermal filler crosslinked with ribose [abstract]. J Am Acad Dermatol 2008;58:AB63. 8. Monstrey SJ, Pitaru S, Hamdi M, et al. A two-stage phase I trial of Evolence30 collagen for soft-tissue contour correction. Plast Reconstr Surg 2007;120:303311. 9. Landau M. Lip augmentation and rejuvenation using a novel, porcine collagen-derived filler. J Drugs Dermatol 2008;7:236240. 10. Klein AW. Indications and implantation techniques for the various formulations of injectable collagen. J Dermatol Surg Oncol 1988;14 (Suppl 1):2730. 11. Bauman L. CosmoDerm/CosmoPlast (human bioengineered collagen) for the aging face. Facial Plast Surg 2004;20:125128. 12. Huang-Lee LL, Cheung DT, Nimni ME. Biochemical changes and cytotoxicity associated with the degradation of polymeric glutaraldehyde derived crosslinks. J Biomed Mater Res 1990;24:11851201. 13. Shoshani D, Markovitz E, Cohen Y, Heremans A, Goldlust A. Skin test hypersensitivity study of a cross-linked, porcine collagen implant for aesthetic surgery. Dermatol Surg 2007;33(Suppl 2):S152S158. Accepted for publication January 23, 2009. Reprint requests: Marina Landau, MD, Joshua Ben Nun St., 56 Herzliya Pituach, Israel 46763. E-mail: mlandau@zahav.net.il. Copyright 2009 by The American Society for Aesthetic Plastic Surgery, Inc. 1090-820X/$36.00 doi:10.1016/j.asj.2009.02.010
CONCLUSIONS
The use of Dermicol-P35 30G for lip augmentation and rejuvenation is associated with a high degree of clinician and subject satisfaction. There were minimal and mostly mild adverse events that resolved quickly.
ACKNOWLEDGMENT
Editorial support was provided by Keni CS Lee, PhD, and Mukund Nori, PhD, MBA, of Envision Pharma, Southport, CT.
DISCLOSURES
The author speaks for Johnson & Johnson occasionally during Congresses, presenting her own clinical experience with their product.
Lip Augmentation and Rejuvenation Using Dermicol-P35 30 G
Repair of Acne Scars With Dermicol-P35

Kevin C. Smith, MD
Acne vulgaris is a prevalent skin condition that can cause disfiguring residual scarring. While the complete removal of acne scars is unlikely, several treatments exist that can improve the appearance of acne scars. Dermal fillers offer a simple, nonsurgical corrective procedure that can provide improved skin texture. Dermicol-P35 (Evolence [Ortho Dermatologics, Skillman, NJ]) is a new, highly purified, ribose cross-linked, porcine collagenbased dermal filler that has demonstrated low immunogenicity and results that persist for at least 12 months. This article presents the aesthetic results of a male patient treated with Dermicol-P35 for severe facial acne scars. ( (Aesthetic Surg J 2009;29:S16S18.)
cne vulgaris is a prevalent skin condition that can afflict men and women, generally beginning in the teen years. A common complication of acne is disfiguring residual scarring. Facial acne scars can have a devastating impact on self-esteem and quality of life for many acne sufferers.1 Acne scars are predominantly atrophic and can be classified as rolling, ice pick or pitted, and deep or shallow boxcar.2 While the complete removal of acne scars is unlikely, there exist a variety of treatments that can lessen their appearance.3 These include wire brush dermabrasion, laser resurfacing treatment, ablative fractional laser resurfacing, surgery (such as punch incision), and injected soft tissue fillers.2,4 Surface techniques can be especially useful for shallow scars, but dermal fillers may provide a better option for depressed scars. Dermal fillers offer a simple, nonsurgical corrective option that can improve skin texture and appearance. However, limited benefits have been observed with ice pick scars.3 Ideally, dermal fillers used for acne scar treatment should provide lasting results and should not induce further skin inflammation or the formation of granulomas.5 Several types of dermal fillers have been explored for use in acne scar treatment. Biodegradable fillers include temporary fillers, such as collagen-based (Zyderm [Allergan, Santa Barbara, CA])6 and hyaluronic acid based (Restylane [Medicis Aesthetics, Scottsdale, AZ] and Juvderm [Allergan, Santa Barbara, CA])7 fillers, as well as semipermanent fillers, such as calcium hydroxylapatite gel5 (Radiesse [BioForm Medical, San Mateo, CA]) and poly-L-lactic acid (Sculptra [Dermik Laboratories, Bridgewater, NJ]).8 Permanent filler options include silicone fillers 3 and polymethymethacrylate combined
with bovine collagen (Artefill [Artes Medical, San Diego, CA]).4 Treatment with bovine collagen dermal filler has resulted in the improved appearance of soft scars, but no improvements in the appearance of ice pick scars.6 Similarly, the appearance of saucerized scars was found to improve with calcium hydroxylapatite treatment, but minimal or no improvement was observed for ice pick scars.5 Silicone microdroplet treatment has shown benefits for correcting broad-based depressed scars, with results lasting up to 30 years.3 Bovine collagen dermal fillers have demonstrated efficacy, but are associated with sensitivity in some patients, require a pretreatment skin test, and provide shorter-term results than other dermal fillers.9 Dermicol-P35 (Evolence [Ortho Dermatologics, Skillman, NJ]) is a new, highly purified, porcine collagenbased dermal filler that has demonstrated low immunogenicity and therefore does not require a prior skin test.10 It is produced using the novel Glymatrix technology, which uses a natural sugar, D-ribose, to crosslink collagen molecules instead of a potential toxin, such as glutaraldehyde.11 In addition, results of Dermicol-P35 have been shown to persist for at least 12 months.10 This article presents the results of a male patient treated with Dermicol-P35 for the correction of severe facial acne scarring.
PATIENT AND PROCEDURES Case Study

A 45-year-old male in good health with no comorbid conditions presented with facial scarring (a mixture of depressed scars and some ice pick scars on both cheeks) resulting from severe acne (Figure 1A, B). The patient had not received any previous acne scar treatment with a dermal filler. No topical anesthetic or ice was used before injection. Dermicol-P35 was supplied as a singleuse, prefilled sterile syringe.
From the Niagara Falls Dermatology and Skin Care Center, Niagara Falls, Ontario, Canada.
Figure 1. A, B, Pretreatment view of a 45-year-old male with facial acne scars immediately before injections. C, D, One month posttreatment with 1 mL of Dermicol P-35. These photos were taken immediately prior to this patients second treatment. E, F, Two months after the first treatment and one month after the second treatment. The total cumulative dose of Dermicol P-35 was 2 mL.
At each visit, before collagen filler injection, the scars to be treated were marked and intradermal injections of normal saline were administered using a 1-mL insulin syringe (BD-II; Becton Dickinson, Franklin Lakes, NJ) with attached 30-gauge 8-mm needle. Each saline injection of 0.1 to 0.2 mL raised a hard wheal and caused hydrostatic dissection of the scar tissue. Injection discomfort was reduced by the local anesthetic effect of 0.9% benzyl alcohol preservative in the normal saline solution. Approximately 2 minutes after the saline injection, 0.05 to 0.1 mL of Dermicol-P35 was injected into the
Repair of Acne Scars With Dermicol-P35
mid dermis of each scar, using a 30-gauge half-inch needle. To further reduce injection discomfort, 0.15 mL of 2% lidocaine without epinephrine was mixed into each syringe of dermal filler. After each Dermicol-P35 injection, the treated area was immediately massaged to ensure proper placement of the filler. Improvements were monitored by referring to pretreatment photos taken under standardized oblique lighting conditions.
RESULTS
The patient underwent 2 treatment sessions, with a dose of 1 mL (1 syringe) injected at each treatment session.
The injection procedure was well-tolerated. Results were apparent immediately after each procedure, there was no down time, and there were no complaints of bruising or postprocedure discomfort. At the 1-month follow-up visit, the appearances of depressed scars and skin texture were still visibly improved (Figure 1C, D). Ice pick scars were still visible. No bruising, swelling, or granulomas were observed at this visit. The patient was so pleased that an additional 1 mL treatment was administrated at the 1-month follow-up visit. At the 2-month follow-up visit, after a total of 2 mL of Dermicol-P35 had been injected over 2 sessions, the appearance of the depressed acne scars was greatly diminished (Figure 1E, F). The F contour of the face was also smoother and greatly improved in the treated areas. Ice pick scars were still visible, but their appearance was minimized. There were no adverse events, no down time reported, and the patient was highly satisfied with his aesthetic outcome.
4. Rivera AE. Acne scarring: a review and current treatment modalities. J Am Acad Dermatol 2008;59:659676. 5. Goldberg DJ, Amin S, Hussain M. Acne scar correction using calcium hydroxylapatite in a carrier-based gel. J Cosmet Laser Ther 2006;8: 134136. 6. Varnavides CK, Forster RA, Cunliffe WJ. The role of bovine collagen in the treatment of acne scars. Br J Dermatol 1987;116:199206. 7. Vedamurthy M. Soft tissue augmentationUse of hyaluronic acid as dermal filler. Indian J Dermatol Venereol Leprol 2004;70:383387. 8. Sadove R. Injectable poly-L-lactic acid: A novel sculpting agent for the treatment of dermal fat atrophy after severe acne. Aesthetic Plast Surg 2009;33:113116. 9. Narins RS, Bowman PH. Injectable skin fillers. Clin Plast Surg 2005;32:151162. 10. Monstrey SJ, Pitaru S, Hamdi M, et al. A two-stage phase I trial of Evolence30 collagen for soft-tissue contour correction. Plast Reconstr Surg 2007;120:303311. 11. Pitaru S, Noff M, Blok L, et al. Long-term efficacy of a novel ribosecross-linked collagen dermal filler: A histologic and histomorphometric study in an animal model. Dermatol Surg 2007;33:10451054. Accepted for publication February 27, 2009. Reprint requests: Kevin C. Smith, MD, FRCPC, Niagara Falls Dermatology and Skin Care Center, Ltd., 201-6453 Morrison St., Niagara Falls, ON, Canada L2E 7H1. E-mail: ksmithderm@gmail.com. Copyright 2009 by The American Society for Aesthetic Plastic Surgery, Inc. 1090-820X/$36.00 doi:10.1016/j.asj.2009.02.014
DISCUSSION
Severe facial acne can result in unsightly and permanent scarring. Dermal fillers offer a minimally invasive, nonsurgical option for the correction of acne scars. Dermicol-P35 (Evolence) is a new dermal filler that has been shown to provide results lasting longer than 12 months and has low immunogenicity. The case reported in this article demonstrates the effectiveness of using Dermicol-P35 for the treatment of severe atrophic acne scarring. Dermicol-P35 administered immediately after distention of the scars with saline produced a high degree of correction, with no papules or other adverse events and high patient satisfaction. While the acne scars were not completely removed, their appearance (along with overall skin texture) was greatly improved.
CONCLUSION
Dermicol-P35 was used to reduce the appearance of acne scars in a male patient. After 2 treatments with Dermicol-P35, acne scars were visibly diminished and skin texture was greatly improved.
ACKNOWLEDGMENTS
The author would like to acknowledge the editorial assistance of Rebecca Jarvis, PhD, of Envision Pharma (Southport, CT) in the preparation of this manuscript.
DISCLOSURES
The author has received research support and served as a consultant and speaker for Johnson & Johnson.
REFERENCES
1. Loney T, Standage M, Lewis S. Not just skin deep: Psychosocial effects of dermatological-related social anxiety in a sample of acne patients. J Health Psychol 2008;13:4754. 2. Alam M, Dover JS. Treatment of acne scarring. Skin Therapy Lett 2006 Dec-2007 Jan;11:79. 3. Barnett JG, Barnett CR. Treatment of acne scars with liquid silicone injections: 30-year perspective. Dermatol Surg 2005;31(11 Pt 2): 15421549.
Nonsurgical Hand Rejuvenation With Dermicol-P35 30G

Christopher Inglefield, BSc, MBBS
Aesthetic hand rejuvenation and restoration have been relatively overlooked compared with other aesthetic enhancements. Cosmetic dermal fillers provide physicians and patients with a nonsurgical option for restoring volume and a youthful appearance to the aging and damaged hand. This paper presents the clinical experience of patients who received Dermicol-P35 30G (Evolence Breeze; Ortho Dermatologics, Skillman, NJ) injection for rejuvenation and restoration of the hand. ( (Aesthetic Surg J 2009;29:S19S21.)
ext to the face, the hands are the most visible part of the body.1 In addition to their utilitarian purposes, hands are also very important for both interpersonal interactions and contact.1 As such, it is important that hands maintain their appearance.2 This attitude is reflected in studies about patients opinions on hand aging.3 Nevertheless, aesthetic hand rejuvenation and restoration have been relatively overlooked compared with other aesthetic enhancements.3,4 There do not appear to be any standards of treatment, possibly because of a lack of consensus on the definition of an ideal hand. Still, there seems to be some agreement on the general characteristics that should define aesthetically pleasing hands, including size proportions, the extent and nature of the soft tissue, the characteristics of the palm, and the quality of the nails.3 As people age, the hand undergoes physical changes caused by intrinsic factors (such as a decrease in skin elasticity and soft tissue atrophy)4-6 and extrinsic factors (such as exposure to light).7,8 Several approaches to hand rejuvenation have been documented, including topical agents (such as creams) to reduce signs of photoaging, microdermabrasion for superficial restoration and rejuvenation of the skin, chemical peels to remove the upper layer of dead skin, various forms of phototherapy, and fat augmentation.4 While each method has met with some degree of success, some of these procedures involve injuring the epidermis.4,9 Fat augmentation does not injure the epidermis, but it often results in prolonged edema.4 There is clearly an unmet medical need for new technologies in aesthetic hand rejuvenation. The introduction of cosmetic dermal fillers has provided physicians and patients with new options for treating the aging and damaged hand.10,11 Such devices largely fall into 2 categories: those that are hyaluronic acidbased
and those that are collagen-based. The latter category can be further divided into those that use human collagen (CosmoDerm and CosmoPlast [Allergan, Santa Barbara, CA]),12 those that use bovine collagen (Zyderm and Zyplast Allergan, Santa Barbara, CA),13 and those that use porcine collagen (Dermitol-P35 30G; Evolence Breeze [Ortho Dermatologics, Skillman, NJ]).14 The collagen in Evolence is crosslinked with D-ribose through novel Glymatrix technology that allows the implant to be effective for a long duration with minimal adverse events when injected into nasolabial folds.15-17 Furthermore, unlike bovine collagen, Dermicol-P35 30G does not require a skin test.18 In this paper, I present some of my clinical experiences using Dermicol-P35 30G for rejuvenation and restoration of the hand.

Twelve patients (10 women and 2 men) who desired a natural looking, youthful improvement in their dorsal hand appearance were treated. Dermicol-P35 30G is supplied as a sterile, 1-mL, single-use syringe with a 30gauge needle. Before treatment, each patients medical history was collected and each underwent a full consultation and physical examination. Patients hands were assessed for skin elasticity, photoaging, volume loss, atrophy, and prominence of dorsal veins and tendons. After informed consent was obtained and pretreatment photographs were taken, topical local anesthetic cream was applied to the hand 20 to 30 minutes before injection. The skin was also cleaned with a topical antiseptic before injection. Dermicol-P35 30G was injected subcutaneously, either by serial puncture or linear threading technique, as appropriate. Firm massage was performed following injection to ensure a smooth result. After treatment, the patients were instructed to avoid vigorous use of their hands for 24 hours. Normal hand washing was allowed and patients were instructed to elevate the hand if swelling was evident.
The author is in private practice in London, United Kingdom.

Figure 1. A, Pretreatment view of a 54-year-old woman. B, Posttreatment view immediately after injection with 1.5 mL of Dermicol-P35 30G.
Figure 2. A, Pretreatment view of a 38-year-old man. B, Posttreatment view immediately after injection with 3.5 mL of Dermicol-P35 30G.
Patient satisfaction was rated on a scale of 0 (defined as no improvement, or low patient satisfaction) to 4 (defined as significant improvement, or high patient satisfaction). A posttreatment assessment was performed at 4 weeks, with optional touch-up treatment. Additional follow-up visits were scheduled at both 8 and 12 weeks. Adverse events were assessed for 3 months following the procedure.
with 1 of 24 hands. Minimal to no swelling was evident for all patients 24 hours postinjection. No cases of allergic reaction, infection, or lumps were observed. Mild discomfort lasting 24 to 48 hours was reported by some patients. All patients returned to normal activities after 24 hours. Minor bruising was observed in 2 out of 12 patients.
RESULTS
Twelve patients (a total of 24 hands) received hand augmentation treatment with Dermicol-P35 30G dermal filler. Patients ranged in age from 21 to 53 years (mean 41.5 years). An average of 1.2 mL of Dermicol-P35 30G was injected into each hand. Patients were followed for 8 to 24 weeks (mean 15.6 weeks). Clinical cosmetic results were maintained in 22 of 24 hands until at least the 3-month follow-up visit. Patients reported high satisfaction with the results of their treatment. The mean patient satisfaction score was 3.7; patients were very satisfied with 23 of 24 hands and satisfied S20 Volume 29 Number 3S May/June 2009
Patients
The 2 patients featured here were injected with Dermicol-P35 30G to improve hand appearance by restoring lost hand volume and reducing the prominence of dorsal tendons and joints. Greatly improved hand appearance was maintained at least 8 weeks postinjection. Tendons and joints were less prominent and the hands appeared smoother and more youthful. Before and immediately after treatment, photographs were taken of a 54-year-old woman injected with 1.5-mL of filler in each hand (Figure 1). Similarly, photographs were taken of a 38-year-old man before and immediately after treatment with 3.5 mL of filler in each hand (Figure 2).
DISCUSSION
While the appearance of the skin on aging hands can be improved with surface treatments such as chemical peeling, bleaching, laser resurfacing, and microdermabrasion, these methods do not address the loss of volume that can occur with age.4 Patients seeking to restore hand volume have been limited primarily to autologous fat injection. Fat injections require a separate harvesting procedure and can produce lumpy results. While the duration of efficacy for fat injections has been shown to be longer, the fat injection procedure can result in complications, including infection and marked postoperative edema.4 Recently, dermal fillers have been explored as a potential nonsurgical alternative to fat injections. A study published last year comparing the efficacies of dermal fillers containing human collagen (CosmoPlast) and hyaluronic acid (Restylane [Medicis Aesthetics, Scottsdale, AZ]) showed that although injections with the latter were more painful to the patient, they provided superior aesthetic efficacy in improving the appearance of the hand than did injections with human collagen.19 In clinical trials, Dermicol-P35 30G porcine collagen dermal filler has demonstrated low immunogenicity and persistence of results lasting at least 12 months.17,18 We found that Dermicol-P35 30G was efficacious at restoring hand volume and reducing the prominence of dorsal veins and tendons, thereby greatly improving hand appearance. Dermicol-P35 30G appears to be well tolerated, with patients reporting only mild adverse events. Results were maintained for at least 3 months and patients reported high satisfaction. While further study is necessary, based on our clinical experience, Dermicol-P35 30G provides a promising option for patients considering nonsurgical dorsal hand augmentation.
CONCLUSION
Dermicol-P35 30G is a newly available porcine collagenbased dermal filler for use in nonsurgical soft tissue augmentation. Patients who have undergone treatment with Dermicol-P35 30G for the correction of hand deformities and/or aging experienced minimal adverse events and reported satisfaction with their results.
3. Bains RD, Thorpe H, Southern S. Hand aging: Patients opinions. Plast Reconstr Surg 2006;117:22122218. 4. Butterwick KJ. Rejuvenation of the aging hand. Dermatol Clin 2005;23:515527, vii. 5. Tzaphlidou M. The role of collagen and elastin in aged skin: An image processing approach. Micron 2004;35:173177. 6. Uitto J. The role of elastin and collagen in cutaneous aging: Intrinsic aging versus photoexposure. J Drugs Dermatol 2008;7(2 Suppl):S12S16. 7. Giacomoni PU, Rein G. A mechanistic model for the aging of human skin. Micron 2004;35:179184. 8. Jakubietz RG, Kloss DF, Gruenert JG, Jakubietz MG. The ageing hand. A study to evaluate the chronological ageing process of the hand. J Plast Reconstr Aesthet Surg 2008;61:681686. 9. Aust MC, Reimers K, Repenning C, et al. Percutaneous collagen induction: Minimally invasive skin rejuvenation without risk of hyperpigmentation-fact or fiction? Plast Reconstr Surg 2008;122:15531563. 10. Broder KW, Cohen SR. An overview of permanent and semipermanent fillers. Plast Reconstr Surg 2006;118(3 Suppl):7S14S. 11. Engelman DE, Bloom B, Goldberg DJ. Dermal fillers: Complications and informed consent. J Cosmet Laser Ther 2005;7:2932. 12. Bauman L. Cosmoderm/Cosmoplast (human bioengineered collagen) for the aging face. Facial Plast Surg 2004;20:125128. 13. Klein AW. Collagen substances. Facial Plast Surg Clin North Am 2001;9:205218, viii. 14. Monstrey SJ, Pitaru S, Hamdi M, et al. A two-stage phase I trial of Evolence30 collagen for soft-tissue contour correction. Plast Reconstr Surg 2007;120:303311. 15. Narins RS, Brandt FS, Lorenc ZP, et al. A randomized, multicenter study of the safety and efficacy of Dermicol-p35 and non-animal-stabilized hyaluronic acid gel for the correction of nasolabial folds. Dermatol Surg 2007;33(Suppl 2):S213221. 16. Pitaru S, Noff M, Blok L, et al. Long-term efficacy of a novel ribosecrosslinked collagen dermal filler: A histologic and histomorphometric study in an animal model. Dermatol Surg 2007;33:10451054. 17. Narins RS, Brandt FS, Lorenc ZP, et al. Twelve-month persistency of a novel ribose-crosslinked collagen dermal filler. Dermatol Surg 2008;34(Suppl 1):S31S39. 18. Shoshani D, Markovitz E, Cohen Y, Heremans A, Goldlust A. Skin test hypersensitivity study of a crosslinked, porcine collagen implant for aesthetic surgery. Dermatol Surg 2007;33(Suppl 2):S152S158. 19. Man J, Rao J, Goldman M, A double-blind, comparative study of nonanimal-stabilized hyaluronic acid versus human collagen for tissue augmentation of the dorsal hands. Dermatol Surg 2008;34:10261031. Accepted for publication March 24, 2009. Reprint requests: Christopher Inglefield, BSc, MBBS, FRCS (Plast), London Bridge Plastic Surgery, 13 Tooley St., London SE1 2PE, United Kingdom. Email: chris@lbps.co.uk. Copyright 2009 by The American Society for Aesthetic Plastic Surgery, Inc. 1090-820X/$36.00 doi:10.1016/j.asj.2009.03.008
ACKNOWLEDGMENTS
The author acknowledges the editorial assistance provided by Mukund Nori, PhD, MBA, and Rebecca Jarvis, PhD, of Envision Pharma, Inc (Southport, CT) in the preparation of this manuscript.
DISCLOSURES
The author has no financial interest in manufacturers of products mentioned in this article.
REFERENCES
1. Goldman A, Prati C, Rossato F. Hand rejuvenation using intense pulsed light. J Cutan Med Surg 2008;12:107113. 2. Jakubietz RG, Jakubietz MG, Kloss D, Gruenert JG. Defining the basic aesthetics of the hand. Aesthetic Plast Surg 2005;29:546551. Volume 29 Number 3S May/June 2009 S21
Nonsurgical Hand Rejuvenation With Dermicol-P35 30G
The Use of Dermicol-P35 Dermal Filler for Nonsurgical Rhinoplasty

Daniel Cassuto, MD
A growing number of patients with congenital or acquired nasal defects is seeking nonsurgical procedures to correct the appearance of their nose. The use of fillers for the correction of nasal deformities is expanding because of their low risk and reversibility compared with surgery. Dermicol-P35 (Evolence; Ortho Dermatologics, Skillman, NJ) is a novel crosslinked, fibrillar type I collagen isolated from porcine tendons that has not been associated with the same degree of immunogenicity as bovine collagen. The use of Dermicol-P35 in this study of 12 subjects was associated with high tolerance, as well as a high degree of satisfaction. ( (Aesthetic Surg J 2009;29:S22S24.)
he aging process affects the physical appearance of the face, including the nose. Usually, the tip of the nose begins to droop because of the loss of subcutaneous tissues, which further exacerbates the visual impact of aging. Increasingly, patients undergoing marionette line corrections and lip augmentations are also considering nose augmentation to achieve a more balanced overall improvement of the face. Although the improvement afforded by traditional rhinoplasty is wellestablished, it remains a costly and invasive procedure that takes time to heal and may lead to scarring.1,2 The use of injectable dermal filler for nose augmentation or secondary rhinoplasty is gaining popularity because of its minimally invasive nature and quasi-immediate effect following the procedure.3 Two of the most popular dermal fillers are hyaluronic acid (HA) and collagen.4 The first resorbable fillers for aesthetic enhancement, introduced more than 20 years ago, were collagens. However, these early collagens suffered from a lack of longevity and were subsequently replaced by HA-based fillers. Pure HA is a naturally occurring linear polysaccharide that poses minimal risk of immunogenicity. Rhinoplasty augmentation and reconstruction trials using HA have shown favorable safety and efficacy results.3,5,6 Because of the hygroscopic nature of HA fillers, bruising and swelling remain possible side effects. Some recent studies have also raised concerns over the delayed adverse events associated with HA.5,6 Glymatrix collagen filler Dermicol-P35 (Evolence [Ortho Dermatologics, Skillman, NJ]) is a suspension of crosslinked, fibrillar type I collagen isolated from porcine tendons. Dermicol-P35 is considered more human-like and has not been associated with the same degree of
immunogenicity as bovine collagen.7 The inter- and intramolecular crosslinking of collagen fibers in Dermicol-P35 fillers are produced via D-ribose glycation, a naturally occurring nonenzymatic series of reactions between sugars and proteins. This results in a product that exceeds the clinical performance of previous collagen-based devices and includes advantages such as longevity, low immunogenicity, easy injectability, natural-appearing results, and lower rates of postinjection swelling and bruising.8 In a phase III study, direct comparison of Dermicol-P35 and Restylane (Medicis Aesthetics, Scottsdale, AZ) in a split-face design showed that both products were equally effective in reducing nasolabial folds, with fewer adverse events being reported for Dermicol-P35.9 This article focuses on the the authors clinical experience with patients who underwent rhinoplasty augmentation procedures using Dermicol-P35.
METHODS
A total of 12 patients were enrolled in this study. The number of sessions was not limited in advance but was determined retrospectively by patient satisfaction. In case of an uneven correction, the filler was manually molded immediately after injection. Dermicol-P35 30G (Evolence Breeze) was used in most patients until the spring of 2008, when the consistency of Dermicol-P35 27G (Evolence) was improved, thereby avoiding the occurrence of needle clogging. This improved consistency allowed Evolence Classic to be used for delicate procedures, such as rhinoplasty augmentation. The primary difference between the 2 products is the shorter collagen fiber length in Dermicol-P35 30G, which allows it to be delivered through a 30-gauge needle instead of a 27gauge needle. Only topical anesthesia was used (10% lidocaine cream). Satisfaction was recorded on a scale of 1 to 5.
From the Department of Plastic Surgery, University of Catania, Catania, Italy.
RESULTS
The demographic information of the 12 patients, who were between 23 and 63 years of age (mean 43 years), is summarized in the Table. The majority of the patients were women (4:1). Skin types were Fitzpatrick 2 and 3. Trauma was the main reason for patients in the study to opt for a rhinoplasty augmentation procedure; the other remaining reasons were rhinoplasty and basal cell carcinoma excision surgery. Although surgery was indicated in 2 rhinoplasty cases, these patients, who had already undergone a secondary rhinoplasty, were reluctant to have surgery a third time. The 3 patients who had undergone basal cell carcinoma excision surgery opted
Table. Demographics and results by patient Patient no. Age (y) 1 2 3 4 5 6 7 8 9 10 11 12 Mean 44 23 49 46 53 31 57 63 42 29 51 32 43 Fitzpatrick skin type 2 3 2 2 3 3 3 3 3 3 3 3
for a soft tissue defect correction via injection, because they preferred cosmetic improvement without any additional surgery. All patients tolerated the injections without experiencing any adverse events. The average amount of Dermicol-P35 27G or 30G injected was 0.6 mL. Most corrections (67%) were accomplished in 1 session, while the rest required a touch-up after 1 month. The mean follow-up was 8 months, during which the correction was stable. The average satisfaction score was 4.6 out of 5. These data are summarized in the Table. Photographic evidence of a patient before and after treatment is given in the Figure.
Sex F F F F F M M F F F M F 1:4 (M:F)
Etiology Trauma Rhinoplasty Trauma BCC BCC Trauma Rhinoplasty BCC Trauma Trauma Trauma Trauma
Injected volume, mL 0.6 0.8 0.5 0.6 0.5 0.4 0.5 1.0 0.6 0.4 0.6 0.7 0.6
Follow-up, months 8 16 14 12 2 8 15 7 2 5 9 8 8
No. of sessions 1 2 2 2 1 1 1 2 1 1 1 1 1.3
Satisfaction on scale 1 to 5 5 4 5 4 5 4 5 5 5 4 5 4 4.6
AEs
DermicolP35 type 30 G 30 G 30 G 30 G 27 G 30 G 30 G 30 G 27 G 27 G 30 G 30 G
AE, Adverse event; BCC, basal cell carcinoma; F, female; M, male. Dermicol-P35 is manufactured by Ortho Dermatologics (Skillman, NJ).
Figure. A, Pretreatment view of a 49-year-old woman. B, Posttreatment view immediately after nonsurgical rhinoplasty with Dermicol-P35 30G. C, Posttreatment view 13 months after nonsurgical rhinoplasty with Dermicol-P35 30G.
The Use of Evolence Dermal Filler for Nonsurgical Rhinoplasty Volume 29 Number 3S May/June 2009 S23
DISCUSSION
Dermicol-P35 is composed of collagen fibers that fix to the tissue and do not migrate from the location of injection. It also has a color that resembles that of the natural dermis. As such, Dermicol-P35 can be used in locations where the skin is very thin, such as the top of the nose, without appearing as a blemish. This advantage is obviously very important in the field of cosmetic medicine. The product also acts as a scaffold to the surrounding tissues, promoting neovascularization and new endogenic collagen formation.10 As previously mentioned, the use of HA-based fillers is limited by the bruising and swelling that occur after injection. The use of earlier collagens was limited because of their high immunogenicity, the need for a pretreatment skin test, and their lack of longevity. These shortcomings are mostly resolved by the introduction of Dermicol-P35. Because of the sugar-based inter- and intramolecular crosslinking of collagen fibers in Dermicol-P35, the product is highly persistent and hypersensitivity is minimal.7,11 The lack of reactivity with porcine collagen was particularly reassuring in patients after tumor excision.10 Furthermore, it helped to keep local tissues available for eventual reconstruction with flaps in case of a recurrence. Particular care was taken when performing injections in patients with secondary and tertiary rhinoplasty, so that flaps with limited perfusion were not separated from their vascular bed by the filler. A histologic study has shown that Dermicol-P35 27G was surrounded by a thin capsule after 2 to 3 months.10 Macroscopically, 3 months after injection, the implant looks like a firm, dry cottage cheese, which makes it easy to identify, dissect, and remove during future surgery, if necessary.
3. Han SK, Shin SH, Kang HJ, Kim WK. Augmentation rhinoplasty using injectable tissue-engineered soft tissue: A pilot study. Ann Plast Surg 2006;56:251255. 4. Carruthers JD, Glogau RG, Blitzer A, Facial Aesthetics Consensus Group Faculty. Advances in facial rejuvenation: Botulinum toxin type A, hyaluronic acid dermal fillers, and combination therapiesconsensus recommendations. Plast Reconstr Surg 2008;121(5 Suppl):5S30S. 5. Redaelli A. Medical rhinoplasty with hyaluronic acid and botulinum toxin A: A very simple and quite effective technique. J Cosmet Dermatol 2008;7:210220. 6. Beer KR. Nasal reconstruction using 20 mg/mL cross-linked hyaluronic acid. J Drugs Dermatol 2006;5:465466. 7. Shoshani D, Markovitz E, Cohen Y, Heremans A, Goldlust A. Skin test hypersensitivity study of a crosslinked, porcine collagen implant for aesthetic surgery. Dermatol Surg 2007;33(Suppl 2):S152S158. 8. Monstrey SJ, Pitaru S, Hamdi M, et al. A two-stage phase I trial of Evolence30 collagen for soft-tissue contour correction. Plast Reconstr Surg 2007;120:303311. 9. Narins RS, Brandt FS, Lorenc ZP, et al. A randomized, multicenter study of the safety and efficacy of Dermicol-P35 and non-animal-stabilized hyaluronic acid gel for the correction of nasolabial folds. Dermatol Surg 2007;33 Suppl 2:S213-21; discussion S221. 10. Pitaru S, Noff M, Blok L, Nir E, Pitaru S, Goldlust A, et al. Long-term efficacy of a novel ribose-cross-linked collagen dermal filler: A histologic and histomorphometric study in an animal model. Dermatol Surg 2007;33:10451054. 11. Huang-Lee LL, Cheung DT, Nimni ME. Biochemical changes and cytotoxicity associated with the degradation of polymeric glutaraldehyde derived crosslinks. J Biomed Mater Res 1990;24:11851201. Accepted for publication March 2, 2009. Reprint requests: Daniel Cassuto, MD, Department of Plastic Surgery, University of Catania, Piazza Cinque Giornate 1, 20129 Milan, Italy. E-mail: daniel.cassuto@fastwebnet.it. Copyright 2009 by The American Society for Aesthetic Plastic Surgery, Inc. 1090-820X/$36.00 doi:10.1016/j.asj.2009.03.003
CONCLUSION
The use of Dermicol-P35 for rhinoplasty augmentation is associated with a high degree of clinician and subject satisfaction in this small set of patients. The properties of this filler render it suitable for the safe correction of some nasal tissue defects without jeopardizing surgical options for the future. More extensive studies would be needed to confirm these results.
ACKNOWLEDGMENT
Editorial support was provided by Keni CS Lee, PhD, and Mukund Nori, PhD, MBA, Envision Pharma (Southport, CT).
DISCLOSURES
The author has no financial interest in products mentioned in this article.
REFERENCES
1. Constantinidis J, Daniilidis J. Aesthetic and functional rhinoplasty. Hosp Med 2005;66:221226. 2. Bracaglia R, Fortunato R, Gentileschi S. Secondary rhinoplasty. Aesthetic Plast Surg 2005;29:230239.
Lip Augmentation and Rejuvenation Using Dermicol-P35 30G: Personal Experiences From My Clinic
Marina Landau, MD
Predictable changes in the lips caused by aging often prompt women to seek lip augmentation and/or rejuvenation. This article describes the clinical experience of patients who underwent lip augmentation and rejuvenation procedures using Dermicol-P35 30G (Evolence Breeze; Ortho Dermatologics, Skillman, NJ) a novel, Dribose cross-linked, porcine collagen dermal filler. The majority of patients reported that the improvement afforded by Dermicol-P35 30G was either good or very good 3 months after their procedure, with minimal adverse effects. (Aesthetic Surg J 2009;29:S12S15.) (
lthough a universal definition describing an ideal pair of lips does not exist, a pair of proportionally projecting feminine lips is generally considered to be sexually attractive.1 As one ages, the lips are inevitably subjected to predictable physical changes that often prompt women to seek lip augmentation and/or rejuvenation in an attempt to improve their appearance. Lip augmentation can be loosely defined as a procedure to enhance the fullness of lips. Lip rejuvenation refers to a procedure for the correction of lip lines, restoration of the contour and buttresses, and redirection of the drooping angles of the lips, all with the aim of reversing the changes associated with aging. In recent years, an increasing number of interventions have been introduced that seek to improve the appearance of the lips. These include tissue or autologous fat grafts, alloplastic implants, and surgical procedures on lip mucosa. The use of injectable fillers is the most common technique for lip shape and volume enhancement. Two of the more popular injectable fillers are made from hyaluronic acid (HA) or collagen, both of which are natural constituents of the normal dermis.2 Collagen was one of the first fillers for aesthetic enhancement and has been in use for more than 20 years. The results of lip shaping by collagen have always been highly appreciated aesthetically. However, because of the relatively short longevity of the results, the early injectable collagen devices have been replaced by HAbased fillers for this indication. In its pure form, HA is a naturally occurring linear polysaccharide with a low risk of immunogenicity because of its lack of species or tissue specificity. Studies on nonanimal, stabilized HA devices
such as Restylane (Medicis Pharmaceutical Corp., Scottsdale, AZ) have shown favorable efficacy results and a low incidence of adverse events following injection.3,4 However, HA fillers are hygroscopic and these procedures on the lips are inevitably accompanied by bruising and swelling. More recent studies have also raised concerns over delayed adverse events relating to HA.5,6 Dermicol-P35 (Evolence; Ortho Dermatologics, Skillman, NJ) is a suspension of crosslinked, fibrillar type I collagen isolated from porcine tendons. DermicolP35 is considered more human-like and has not been associated with the same degree of immunogenicity as bovine collagen.7 The inter- and intramolecular crosslinking of collagen fibers in Dermicol-P35 fillers is produced via D-ribose glycation, a naturally occurring nonenzymatic series of reactions between sugars and proteins. This results in a product that exceeds the clinical performance of previous collagen-based devices and includes advantages such as longevity, low immunogenicity, easy injectability, natural-appearing results, and a lower rate of postinjection swelling and bruising.8 Dermicol-P35 30G is a newer formulation containing shorter collagen fibers that allow the product to flow through a smaller needle lumen. The major practical difference between the 2 products is that Dermicol-P35 27G is delivered through a 27-gauge needle, while DermicolP35 30G is delivered through a 30-gauge needle. This article focuses on the authors clinical experience with patients who underwent lip augmentation and rejuvenation procedures using Dermicol-P35 30G.

Lip augmentation and rejuvenation procedures using Dermicol-P35 30G were performed on 15 patients
From the Dermatology Unit, Wolfson Medical Center, Holon, Israel.
Table. Patient demographics and satisfaction after procedure Patient no. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

F F, Female.
Patient satisfaction Touch-up at 3 months in 2 weeks Very good Very good Good Very good Very good Very good Good Good Satisfactory Very good Good Very good Good Satisfactory Very good + + +
Amount of filler, mL 1.0 1.5 1.0 2.0 2.0 1.2 2.0 1.0 1.0 2.2 1.0 1.0 1.4 1.2 1.8
Nasolabial correction + + + + + +
Indication Augmentation Rejuvenation Rejuvenation Rejuvenation Rejuvenation Augmentation Rejuvenation Augmentation Augmentation Rejuvenation Rejuvenation Rejuvenation Augmentation Augmentation Rejuvenation
Age, y 42 57 60 55 55 47 59 43 44 61 58 57 44 47 56
Sex F F F F F F F F F F F F F F F
(Table). The use of any anticoagulant or antiplatelet medication was prohibited before the procedures. Oral acyclovir (400 mg twice daily for 5 days) was administered to those with a previous history of herpes labialis. A thorough assessment of lip shape, volume, and condition was performed before Dermicol-P35 30G injection. The initial stages of the procedures on lips were performed under local anesthesia because the lips are one of the most sensitive areas of the face. DermicolP35 30G was mixed with a local anesthetic (0.3 mL lidocaine 1%) to render the injections more tolerable to patients. The mixture was performed through a commercially available female-to-female connector under strict aseptic conditions. The results were assessed immediately after the procedure, after 2 to 3 weeks, and after 3 months. Adverse events were assessed by the physician up to 6 months after the procedure.
mal amount of filler (1 mL) required a touch-up 2 weeks after the procedure. The addition of 0.3 mL lidocaine 1% did not affect the longevity or the efficacy of Dermicol-P35 30G. Contrary to cases where topical or regional pretreatment anesthesia was used, no distortion of the lip shape and volume occurred. Because swelling was minimal during the injection, the final result was more visible and could be more easily appreciated by the physician and the patient. In contrast to our previous experience with HA-based dermal fillers, only minimal swelling on the lips was noted after injection with Dermicol-P35 30G. Transient lumps on the lips were reported, but spontaneously cleared within 4 weeks after the procedure.
Patients
Patient 1. A 47-year-old woman (Figure 1) was injected with 1.2 mL of Dermicol-P35 30G into the lower and upper lips in order to enhance their volume and to correct the slight asymmetry in the shape of the right part of the lower lip. Immediate results were obtained, where more symmetric and pleasantly plump lips were observed. No swelling or bruising was noted. Patient 2. A 42-year-old woman presented with an unsatisfactory appearance in the shape of her lips, mainly because of the upper lip, which lacked volume. Lip augmentation to correct the volume and redefine the vermillion border of the lip was performed with 1.0 mL of Dermicol-P35 30G. A comparison made on photographs taken before and after the procedure (Figure 2) shows that the philtral columns were successfully reconstructed, which makes the upper lip look pleasantly shorter.
RESULTS
As we have previously reported, 15 patients were included in the study.9 All of the patients were women, with a mean age of 52.3 years (range 42-61 years). Nine patients underwent lip rejuvenation (with or without correction of the nasolabial folds) and 6 patients underwent lip augmentation (with or without correction of the nasolabial folds; Table). The mean amount of Dermicol-P35 30G used per patient was 1.4 mL (range 1.0-2.2 mL). Three months after the procedures, 13 patients (86.7%) reported that the improvement afforded by Dermicol-P35 30G was either good or very good and 2 patients (13.3%) reported that the improvement was satisfactory. Only 3 patients who initially received a miniLip Augmentation and Rejuvenation Using Dermicol-P35 30 G
Figure 1. Patient 1. A, Pretreatment view of a 47-year-old woman. B, Posttreatment view immediately after the injection of 1.2 mL of DermicolP35 30G into the lower and upper lips.
Figure 2. A, Pretreatment view of a 42-year-old woman. B, Posttreatment view 2 weeks after the injection of 1.0 mL of Dermicol-P35 30G into the upper lip.
Patient 3. A 57-year-old patient with upper lip wrinkles and blurred vermilion border of both lips was injected with 1.0 mL of Dermicol-P35 30G. Three months after the procedure, an almost absolute disappearance of the wrinkles was noted. The postprocedure photograph clearly shows that a redefinition of the vermilion border rejuvenated the patients appearance.
DISCUSSION
Injectable fillers for dermal contour corrections originated with the introduction of Zyderm and Zyplast (McGhan Medical Corp., Fremont, CA)10 injectable bovine collagen in the United States in 1981.9 These agents opened up the possibilities for lip augmentation and rejuvenation to create a fuller appearance. Since the mid-1990s, HA-based fillers have provided an additional option to the physician. As mentioned above, the continuing use of HAbased fillers, especially on the lips, is limited by the bruising and swelling that occur after injection. S14 Volume 29 Number 3S May/June 2009
The ideal injectable filler for immediate correction is characterized by a long-term persistency and a low occurrence of adverse events or complications.11 The use of bovine injectable collagens was limited because of the high incidence of allergies and the need for a pretreatment skin test, as well as their limited duration of clinical contour correction. Although human-sourced collagens such as CosmoDerm and CosmoPlast (Allergan, Santa Barbara, CA) may circumvent the need for skin tests, the use of glutaraldehyde-based crosslinking technology limits the extent of crosslinking that can be achieved and the nature of the crosslinks formed.11,12 The deficiencies of earlier collagen-based fillers are mostly resolved by the introduction of Dermicol-P35 filler. The inter- and intramolecular cross-linking of collagen fibers in Dermicol-P35 filler are generated via glycation, which results in a product that is resistant to local enzymatic degradation.12 In addition, a pretreatment skin test is unnecessary and the occurrence of
Figure 3. Patient 3. A, Pretreatment view of a 57-year-old woman. B, Posttreatment view 3 months after the injection of 1.0 mL of Dermicol-P35 30G into both lips.
hypersensitivity is minimal.13 The sugar-based crosslinkers used to produce Dermicol-P35 also result in a structure with enhanced integrity and strength, which could lead to higher persistency in areas that are subjected to corrections. Based on the experience garnered during this study, Dermicol-P35 30G was found to be especially efficient in the treatment of small upper lip wrinkles (Figure 3). Our experience has shown that these wrinkles are extremely challenging and cannot be efficiently eliminated using HA-based fillers without some swelling of the upper lip skin or linear ridges along the injection lines. On the contrary, the use of Dermicol-P35 30G in the lip region produced relatively minimal swelling and bruising. This rendered the procedure more acceptable and the immediate results could be more easily appreciated. The longevity of the results in the lips was another important advantage of this filler. The advantages of Dermicol-P35 when compared with previous collagen-based fillers were successfully shown in clinical trials.8 The satisfaction expressed by the majority of patients in this study further supported the remarkable effectiveness and safety of Dermicol-P35 30G when used in lip augmentation and rejuvenation procedures.
REFERENCES
1. Sutter RE Jr, Turley PK. Soft tissue evaluation of contemporary Caucasian and African American female facial profiles. Angle Orthod 1998;68:487496. 2. Carruthers JD, Glogau RG, Blitzer A, Facial Aesthetics Consensus Group Faculty. Advances in facial rejuvenation: Botulinum toxin type A, hyaluronic acid dermal fillers, and combination therapiesconsensus recommendations. Plast Reconstr Surg 2008;121(5 Suppl):5S30S. 3. Olenius M. The first clinical study using a new biodegradable implant for the treatment of lips, wrinkles, and folds. Aesthetic Plast Surg 1998;22:97101. 4. Duranti F, Salti G, Bovani B, Calandra M, Rosati ML. Injectable hyaluronic acid gel for soft tissue augmentation. A clinical and histological study. Dermatol Surg 1998;24:13171325. 5. Lowe NJ, Maxwell CA, Lowe P, Duick MG, Shah K. Hyaluronic acid skin fillers: Adverse reactions and skin testing. J Am Acad Dermatol 2001;45:930933. 6. Lupton JR, Alster TS. Cutaneous hypersensitivity reaction to injectable hyaluronic acid gel. Dermatol Surg 2000;26:135137. 7. Nir E, Goldlust A, Shoshani D, Azachi M. Long-term in vivo evaluation of the safety and efficacy of a new porcine collagen dermal filler crosslinked with ribose [abstract]. J Am Acad Dermatol 2008;58:AB63. 8. Monstrey SJ, Pitaru S, Hamdi M, et al. A two-stage phase I trial of Evolence30 collagen for soft-tissue contour correction. Plast Reconstr Surg 2007;120:303311. 9. Landau M. Lip augmentation and rejuvenation using a novel, porcine collagen-derived filler. J Drugs Dermatol 2008;7:236240. 10. Klein AW. Indications and implantation techniques for the various formulations of injectable collagen. J Dermatol Surg Oncol 1988;14 (Suppl 1):2730. 11. Bauman L. CosmoDerm/CosmoPlast (human bioengineered collagen) for the aging face. Facial Plast Surg 2004;20:125128. 12. Huang-Lee LL, Cheung DT, Nimni ME. Biochemical changes and cytotoxicity associated with the degradation of polymeric glutaraldehyde derived crosslinks. J Biomed Mater Res 1990;24:11851201. 13. Shoshani D, Markovitz E, Cohen Y, Heremans A, Goldlust A. Skin test hypersensitivity study of a cross-linked, porcine collagen implant for aesthetic surgery. Dermatol Surg 2007;33(Suppl 2):S152S158. Accepted for publication January 23, 2009. Reprint requests: Marina Landau, MD, Joshua Ben Nun St., 56 Herzliya Pituach, Israel 46763. E-mail: mlandau@zahav.net.il. Copyright 2009 by The American Society for Aesthetic Plastic Surgery, Inc. 1090-820X/$36.00 doi:10.1016/j.asj.2009.02.010
CONCLUSIONS
The use of Dermicol-P35 30G for lip augmentation and rejuvenation is associated with a high degree of clinician and subject satisfaction. There were minimal and mostly mild adverse events that resolved quickly.
ACKNOWLEDGMENT
Editorial support was provided by Keni CS Lee, PhD, and Mukund Nori, PhD, MBA, of Envision Pharma, Southport, CT.
DISCLOSURES
The author speaks for Johnson & Johnson occasionally during Congresses, presenting her own clinical experience with their product.
Lip Augmentation and Rejuvenation Using Dermicol-P35 30 G
CME ASSESSMENT TEST

DERMICOL-P35: TECHNIQUES IN FACIAL AND HAND REJUVENATION
1. Aging of face and hands is a consequence of _____________. a. loss of collagen cross-linking b. increased collagen deposition c. chronologic and environmental processes d. lack of physical activity The 2 most commonly used components of dermal fillers are _________. a. collagen and fat b. collagen and hyaluronic acid c. silicone and fat d. silicone and collagen Dermicol-P35 differs from other collagens in that it ________. a. does not require a skin test prior to use b. is of human origin c. is hydrophylic d. uses glutaraldehyde for cross-linking In patients with acne scars, collagen-based dermal fillers are not successful in treating _______. a. shallow boxcar scars b. pitted scars c. deep boxcar scars d. ice-pick scars A Tyndall effect can be observed when ________. a. autologous fat is injected into the lips b. collagen-based fillers are injected into thin skin areas, eg, under the eyes c. hyaluronic acid-based fillers are injected into thin skin areas, eg, under the eyes d. silicone is injected into thin skin areas, eg, under the eyes 6. Injecting Dermicol-P35 into the hand results in __________. a. increased dorsal vein blood flow b. reduced dorsal vein and tendon prominence c. increased ventral hand soft tissue d. reduced carpal tunnel syndrome The effects of augmenting the lips with DermicolP35 produces results that are ____________. a. swollen b. red c. firm d. visible immediately In rhinoplasty, Dermicol-P35 acts as a __________. a. structural element b. glue c. bridge d. hemostatic agent Injection techniques for cheek augmentation with Dermicol-P35 include __________. a. microdroplets b. depot technique c. crosshatching with linear threading d. pooling
2.
7.
3.
8.
9. 4.
5.
10. Unlike hyaluronic acid-based fillers, Dermicol-P35 _________. a. is hydrophilic b. is a by-product of bacterial fermentation c. may be reversed with an enzyme d. is a suspension of cross-linked fibers
Dermicol-P35: Techniques in Facial and Hand Rejuvenation
CME ASSESSMENT TEST ANSWER SHEET

DERMICOL-P35: TECHNIQUES IN FACIAL AND HAND REJUVENATION CME INSTRUCTIONS
This activity provides 2.5 AMA PRA Category 1 CreditsTM. Access www.elseviercme.com/getcme/YMAJ293S and print your certificate online or forward the Test Answer Sheet and Evaluation Form to the address shown below. Please allow 6-8 weeks for processing. A photocopy of this form is acceptable. The Elsevier Office of Continuing Medical Education Department YMAJ 293S 60B Columbia Road Morristown, NJ 07960 Responses for AMA PRA credit must be submitted by July 30, 2010 or fax to: 973-630-2001. In order to receive credit, all participants must pass 70% of the questions.
ANSWER SHEET (circle the best answer to each question)

1. 2. 3. a a a b b b c c c d d d 4. 5. 6. a a a b b b c c c d d d 7. 8. 9. 10. a a a a b b b b c c c c d d d d
Release Date of Activity: July 1, 2009 Expiration Date of Activity for AMA PRA credit: July 30, 2010 Estimated Time to Complete this Activity: 2.5 Hours
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S26 Volume 29 Number 3S1 May/June 2009
CME EVALUATION FORM

Please evaluate the effectiveness of this activity in helping you to do each of the following by circling your choice on a scale of 1 to 5, with 1 the lowest and 5 the highest. 1. 2. 3. 4. 5. 6. 7. Discuss the role of dermal fillers in aesthetic and corrective procedures Describe the differences between collagen-based and hyaluronic acid-based dermal fillers Determine the issues influencing the choice of dermal filler Identify and describe the technical challenges of injecting dermal fillers in different parts of the face and hands Recognized the key characteristics of Dermicol-P35 How do you rate the overall quality of the activity? How do you rate the educational content of the activity? 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5
Was the information presented to be fair, objective, balanced, and free of bias in the discussion of any commercial product or service? ____Yes _____No If not, please describe:___________________________________________________________________________________ _______________________________________________________________________________________________________ Suggested topics for future activities:________________________________________________________________________ _______________________________________________________________________________________________________ Suggested authors for future activities:_____________________________________________________________________ _______________________________________________________________________________________________________ After participation in this activity, have you decided to change one or more aspects of the treatment of your patients? _____ Yes _____No If yes, what changes will you make: If no, why? Would you be willing to participate in postactivity follow-up surveys? ____Yes ____No
Would you be willing to participate in a phone, email, or in person discussion exploring ways to improve our CME activities? ____Yes ____No The EOCME thanks you for participation in this CME activity. All information provided improves the scope and purpose of our programs and your patients care.
Dermicol-P35: Techniques in Facial and Hand Rejuvenation
Volume 29 Number 3S1 May/June 2009 S27

Dermicol-P35 Collagen - Techniques in Facial and Hand Rejuvenation (2009)

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Volume 29 Number 3S May/June 2009

Dermicol-P35 Collagen: Techniques in Facial and Hand Rejuvenation

S5 CHEEK AUGMENTATION WITH DERMICOL-P35 27G

S16 REPAIR OF ACNE SCARS WITH DERMICOL-P35

S19 NONSURGICAL HAND REJUVENATION WITH DERMICOL-P35 30G

S22 THE USE OF DERMICOL-P35 DERMAL FILLER FOR NONSURGICAL RHINOPLASTY

To submit your manuscript online to Aesthetic Surgery Journal visit www.aestheticsurgeryjournal.com

A2 Volume 29 Number 3S May/June 2009

Volume 29 Number 3S May/June 2009

Aesthetic Surgery Journal

Research David L. Larson, MD

Featured Operative Techniques Editor

Oculoplastic Surgery James. H. Carraway, MD

Rhinoplasty Bahman Guyuron, MD

James Grotting, MD, FACS

Breast Surgery Laurie A. Casas, MD

Mary McGrath, MD, MPH

Body Contouring Al Aly, MD

Cosmetic Medicine Alan Matarasso, MD

Graeme Southwick, MB, BS, FRACS, FACS

Editorial Board continued

Michael Grant, MD, PhD, FACS

Deborah S. Sarnoff, MD, FAAD, FACP

Clinical Professor Department of Dermatology NYU Medical Center

Claudio Cardoso de Castro, MD

OFFICIAL ENGLISH-LANGUAGE JOURNAL OF:

Roland Luijendijk, MD, PhD

OFFICIAL JOURNAL OF:

Interspecialty Consulting Editors

OFFICIAL PUBLICATION OF THE AMERICAN SOCIETY FOR AESTHETIC PLASTIC SURGERY

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Aesthetic Surgery Journal

Dermicol-P35 Collagen: Techniques in Facial and Hand Rejuvenation

Resolution of Conflict of Interest (COI)

Goal of the Activity

Aesthetic Surgery Journal

Determine the issues influencing the choice of

Unapproved Use Disclosure

S2 Volume 29 Number 3S May/June 2009

Aesthetic Surgery Journal

Dr. Bernard is in private practice in White Plains, NY.

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Aesthetic Surgery Journal

Cheek Augmentation With Dermicol-P35 27G

Dr. Sadick is in private practice in New York, NY.

MATERIALS AND METHODS

Figure 1. Diagram of injection sites for cheek augmentation.

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S8 Volume 29 Number 3S May/June 2009

Aesthetic Surgery Journal

Dr. Goldberg is in private practice in New York, NY.

MATERIALS AND METHODS

Volume 29 Number 3S May/June 2009 S11

PATIENTS AND PROCEDURES

From the Dermatology Unit, Wolfson Medical Center, Holon, Israel.

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Table. Patient demographics and satisfaction after procedure Patient no. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Lip Augmentation and Rejuvenation Using Dermicol-P35 30 G

Volume 29 Number 3S May/June 2009 S15

Repair of Acne Scars With Dermicol-P35

PATIENT AND PROCEDURES Case Study

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S18 Volume 29 Number 3S May/June 2009