dermicol-p35 collagen - techniques in facial and hand rejuvenation (2009)

Dermicol-P35 Collagen:Techniques in Facial

and Hand Rejuvenation

Volume 29 • Number 3S • May/June 2009

A1

Table of Contents

S1 CME INFORMATION

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 27GNeil S. Sadick, MD; and Laura Palmisano, RPA-C

S9 CORRECTION OF TEAR TROUGH DEFORMITY WITH NOVEL PORCINECOLLAGEN DERMAL FILLER (DERMICOL-P35)

David J. Goldberg, MD, JD

S12 LIP AUGMENTATION AND REJUVENATION USING DERMICOL-P35 30G:PERSONAL EXPERIENCES FROM MY CLINICMarina Landau, MD

S16 REPAIR OF ACNE SCARS WITH DERMICOL-P35Kevin C. Smith, MD

S19 NONSURGICAL HAND REJUVENATION WITH DERMICOL-P35 30GChristopher Inglefield, BSc, MBBS

S22 THE USE OF DERMICOL-P35 DERMAL FILLER FOR NONSURGICALRHINOPLASTYDaniel Cassuto, MD

Supplement to Aesthetic Surgery Journal

www.aestheticsurgeryjournal.com

This CME supplement is to be published July 2009. This activity is jointly sponsored by the Elsevier Office ofContinuing Medical Education and Aesthetic Surgery Journal and is supported by an educational grant fromOrtho Dermatologics, Inc.

A1-A2_YMAJ_TOC_CP:Layout 1 6/25/09 8:54 AM Page A1

A2 • Volume 29 • Number 3S • May/June 2009

The opinions or views expressed in this professional education supplement are those of the authors and do not necessarily reflect the opinions orrecommendations 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 bederived from the professional literature or other clinical sources. Because of the differences between in vitro and in vivo systems and between laboratoryanimal models and clinical data in humans, in vitro and animal data may not necessarily correlate with clinical results.

Contents—continued

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

S25 CME TEST QUESTIONS

S26 CME ASSESSMENT TEST ANSWER SHEET

S27 CME EVALUATION FORM

Editor’s Note: As of 2006, Allergan completed acquisition of Inamed (Santa Barbera, CA), so all have beenchanged to reflect the merger.

A1-A2_YMAJ_TOC_CP:Layout 1 6/25/09 8:54 AM Page A2

Volume 29 • Number 3S • May/June 2009

A3

Editor in ChiefFoad Nahai, MDClinical Professor of Plastic Surgery

Emory University School of Medicine

Associate EditorJeffrey M. Kenkel, MDProfessor and Vice-Chairman, Department of Plastic Surgery

University of Texas Southwestern Medical Center

Section EditorsFacial Surgery

Fritz E. Barton, Jr., MDClinical Professor of Plastic Surgery


Oculoplastic Surgery

James. H. Carraway, MDProfessor and Chairman, Division of Plastic Surgery

Eastern Virginia Medical School

Rhinoplasty

Bahman Guyuron, MDKiehn-DesPrez Professor and Chief

Division of Plastic SurgeryCase Western Reserve University and University Hospitals Case Medical Center

Breast Surgery

Laurie A. Casas, MDAssociate Professor

Division of Plastic and Reconstructive SurgeryDepartment of SurgeryNorthwestern University Feinberg School of Medicine

Body Contouring

Al Aly, MDClinical Professor of Plastic Surgery

University of California at Irvine

Cosmetic Medicine

Alan Matarasso, MDClinical Professor

Department of Plastic and Reconstructive SurgeryAlbert Einstein College of Medicine

Research

David L. Larson, MDChairman and George J. Korkos Professor of Plastic andReconstructive Surgery

Medical College of Wisconsin

Featured Operative Techniques EditorMichael J. Yaremchuk, MDClinical Professor of Surgery

Division of Plastic and Reconstructive SurgeryHarvard Medical School

CME EditorRichard J. Warren, MDClinical Professor

Division of Plastic Surgery, Department of SurgeryUniversity of British Columbia

EditorsA. Jay Burns, MDAssistant Professor of Plastic Surgery


James Grotting, MD, FACSClinical Professor of Surgery, Division of Plastic Surgery

University of Alabama at Birmingham andUniversity of Wisconsin, Madison

Dennis J. Hurwitz, MDClinical Professor of Surgery (Plastic)

University of Pittsburgh Medical Center

Mary McGrath, MD, MPHProfessor of Surgery, Division of Plastic Surgery

University of California San Francisco

Peter J. Rubin, MDDirector, Body Contouring Program

Associate Professor of Plastic Surgery University of Pittsburgh

Graeme Southwick, MB, BS, FRACS, FACSHonorary Senior Lecturer

Department of Anatomy and Cell Biology Montash University,Australia

Editorial Board

Continued

Aesthetic Surgery JournalA Peer-Reviewed International JournalA P R i d I t ti l J l

www.aestheticsurgeryjournal.comFounding EditorRobert W. Bernard, MD

Editor EmeritusStanley A. Klatsky, MD

A3-A4_YMAJ_Masthead_CP:Layout 1 6/24/09 3:20 PM Page A3

A4 • Volume 29 • Number 3S • May/June 2009 Aesthetic Surgery Journal

Berish Strauch, MDProfessor and Chairman Emeritus

Department of Plastic and Reconstructive SurgeryAlbert Einstein College of Medicine

Luis Vasconez, MDProfessor and Director

Division of Plastic Surgery, Department of SurgeryUniversity of Alabama-Birmingham School of Medicine

James Zins, MDChairman, Department of Plastic Surgery

Cleveland Clinic

Statistical EditorNavin K. Singh, MD, MBAAssistant Professor of Plastic Surgery

The Johns Hopkins University School of Medicine

International EditorsAlberto Arguello, MDProfessor of Plastic Surgery

University of Costa RicaSan Jose, Costa Rica

Jenny Carvajal, MDMedellin, Colombia

Claudio Cardoso de Castro, MDChief and Professor

University of the State of Rio de JaneiroRio de Janeiro, Brazil

Apirag Chuangsuwanich, MDAssociate Professor, Faculty of Medicine

Sirirraj Hospital, Mahidol UniversityBangkok, Thailand

Seum Chung, MDClinical Professor of Plastic Surgery

Yonsei College of MedicineSeoul, South Korea

Lokesh Kumar, MDSenior Consultant Plastic Surgeon

Department of Plastic & Reconstructive SurgeryIndraprastha Apollo HospitalNew Delhi, India

Roland Luijendijk, MD, PhDChairman, Department of Plastic and Reconstructive Surgery

Diakonessenhuis, Utrecht, the Netherlands

Fernando Magallanes, MDMexico City, Mexico

Kitaro Ohmori, MDTokyo, Japan

Michael Scheflan, MDTel Aviv, Israel

Interspecialty Consulting EditorsJeffrey L. Apfelbaum, MDProfessor and Chair, Department of Anesthesia and Critical Care

University of Chicago Pritzker School of Medicine

Daniel G. Becker, MDClinical Associate Professor Division of Facial Plastic and

Reconstructive SurgeryDepartment of Otolaryngology-Head and Neck SurgeryUniversity of Pennsylvania Medical Center and University ofVirginia Medical Center

Michael Grant, MD, PhD, FACSAssistant Professor of Ophthalmology and Plastic Surgery

Wilmer Eye Institute at John Hopkins

Thomas E. Joiner, MDDistinguished Research Professor & Bright-Burton Professor of

PsychologyFlorida State University

Seth Matarasso, MDClinical Professor of Dermatology

University of California School of MedicineSan Francisco, CA

Deborah S. Sarnoff, MD, FAAD, FACPClinical 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

OFFICIAL PUBLICATION OF THE AMERICAN SOCIETY FOR AESTHETIC PLASTIC SURGERY

Editorial Board continued

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 SurgeryDutch Society for Aesthetic Plastic Surgery Indian Association of Aesthetic Plastic SurgeonsIsrael Society for Plastic SurgeonsJapan Society of Aesthetic Plastic SurgeryKorean Society for Aesthetic Plastic Surgery Mexican Association of Plastic, Aesthetic, and Reconstructive Surgery Society of Plastic and Reconstructive Surgeons of Thailand

OFFICIAL JOURNAL OF:The Rhinoplasty Society

A3-A4_YMAJ_Masthead_CP:Layout 1 6/24/09 3:20 PM Page A4

Nature of Relevant Financial Relationship(Include all those that apply)

Faculty Member Commercial Interest For What Role?

Robert W Bernard Allergan ConsultantDaniel Cassuto NoneDavid J Goldberg NoneChristopher Inglefield NoneMarina Landau Johnson & Johnson SpeakerLaura Palmisano NoneNeil S Sadick Johnson & Johnson Faculty, Evolence Star ProgramKevin C Smith Johnson & Johnson Grant, Research Support, Consultant, Speaker

CME Information

Dermicol-P35 Collagen: Techniques in Facialand Hand Rejuvenation

Accreditation StatementThis activity has been planned and implemented inaccordance with the Essential Areas and policies of theAccreditation Council for Continuing Medical Education(ACCME) and jointly sponsored by the Elsevier Office ofContinuing Medical Education (EOCME) and AestheticSurgery Journal. The EOCME is accredited by theACCME to provide continuing medical education (CME)for physicians.

Credit DesignationThe EOCME designates this educational activity for amaximum of 2.5 AMA PRA Category 1 Credit(s)™.Physicians should only claim credit commensurate withthe extent of their participation in the activity.

Faculty DisclosuresAs a sponsor accredited by the ACCME, it is the policy ofthe EOCME to require the disclosure of anyone who is ina position to control the content of an educational activity.All relevant financial relationships with any commercialinterests and/or manufacturers must be disclosed toparticipants at the beginning of each activity (see tablebelow).

The faculty of this CME activity disclose the following:

Resolution of Conflict of Interest (COI)The Elsevier Office of CME has implemented a processto resolve COI for each CME activity. In order to helpensure content objectivity, independence, fair balance,and ensure that the content is aligned with the interestof the public, the EOCME has resolved the conflict byexternal content review.

Financial SupportThe Elsevier Office of CME and Aesthetic SocietyJournal gratefully acknowledge the educational grantprovided by Ortho Dermatologics, Inc.

Intended AudienceThis activity is intended for aesthetic and plastic sur-geons, dermatologists, and other healthcare profession-als involved in providing treatment for the aestheticneeds of patients, with a focus on the face and hands.

Goal of the ActivityLoss of structural integrity, elasticity, and regenerativecapability of the skin is a consequence of aging, achronologic and environmental process. These changesoften have negative psychological effects, especially in aculture that values youthful appearances. Aesthetic

Volume 29 • Number 3S • May/June 2009 • S1Aesthetic Surgery Journal

S1-S2_YMAJ669_CME_Enduring_CP:Layout 1 6/24/09 3:34 PM Page S1eee geeeeeee egeee

Release date: July 1, 2009Expiration date: July 30, 2010Estimated time to complete activity: 2.5 Hours

replenishment is associated with better work perform-ance and self-esteem. Despite the difficult economy,according to both the American Society for AestheticPlastic Surgery and the American Society of PlasticSurgeons, there is a great demand for aesthetic proce-dures. Dermal fillers have long been recognized as animportant tool to address patient needs for both aestheticenhancements and for soft tissue corrections required asa result of trauma, disease, or congenital defect.

This supplement provides an overview of the differenttypes of dermal fillers on the market. It further focuseson the characteristics, utility, and versatility of a newdermal filler, Dermicol-P35. This supplement addressesthe unique technical challenges presented by the use ofthis product in the different regions of the face andhands. Finally, this supplement also provides informa-tion on the options available based on the aestheticstructural needs of the patient and the region of the faceinto which the product is to be injected.

Educational ObjectivesUpon completion of this activity, participants will beable to:

• Discuss the role of dermal fillers in aesthetic andcorrective procedures

• Describe the differences between the 2 major classesof dermal fillers

• Recognize the unique characteristics of Dermicol-P35

• Determine the issues influencing the choice ofdermal filler based on aesthetic structural needand region of the face or hands

• Identify the technical challenges of injecting dermalfillers into different parts of the face and hands

Unapproved Use DisclosureThe EOCME requires CME faculty to disclose to the par-ticipants:

1) When products or procedures being discussed areoff-label, unlabeled, experimental, and/or investi-gational (not US Food and Drug Administration[FDA] approved); and

2) Any limitations on the information that is present-ed, such as data that are preliminary or that repre-sent ongoing research, interim analyses, and/orunsupported opinion.

Faculty may discuss information about pharmaceuti-cal agents that is outside of FDA approved labeling. Thisinformation is intended solely for Continuing MedicalEducation and is not intended to promote off-label useof these medications. If you have questions, contact themedical affairs department of the manufacturer for themost recent prescribing information.

We encourage participation by all individuals. If youhave any special needs, please contact Craig Smith at212-462-1933, or [email protected] for assistance.Responses must be submitted by July 30, 2010.

Aesthetic Surgery JournalS2 • Volume 29 • Number 3S • May/June 2009

S1-S2_YMAJ669_CME_Enduring_CP:Layout 1 6/24/09 3:34 PM Page S2eee geeeeeee egeee

mailto:[email protected]

Introduction


The Science and Technology of Dermicol-P35:Utility and Safety in Aesthetic Procedures

Robert W. Bernard, MD

Aging is both chronologic and environmental,resulting in skin that increasingly loses structuralintegrity, elasticity, and regenerative capability.1 In

a culture that values a youthful appearance, its loss canoften have psychological effects on an individual.Consequently, aesthetic rejuvenation is linked with betterself-esteem and work performance.2 From 2006 to 2007,the total number of cosmetic procedures in the UnitedStates increased by between 2.4% and 4%.3,4

Injectable medical devices are an important addition tothe choices that aesthetic surgeons and dermatologistscan offer patients for restoration of a youthful appearance.The ideal characteristics of an injectable medical devicefor aesthetic use are biocompatibility, a predictably longduration of clinical effect (�12 months; ie. the retentionof 3-dimensional structure at the site of implantation),minimal adverse effects, reduced or no hypersensitivityreaction, and no need for a pretreatment skin test.

Dermal fillers fall into 2 main categories, dependingon whether they are based on hyaluronic acid (HA) orcollagen.5 Constituting approximately 2% of the skin, HAis a glycosaminoglycan polysaccharide with a repeatingdisaccharide structure and is therefore inherently unlikelyto provoke an immune response.6,7 It is also very hygro-scopic; dermal fillers that use unmodified HA have a veryshort lifespan in the body and can be eliminated from theinjection site within a week.7 Indeed, the number of HAfillers on the market shows that, while they share basicprinciples, there are distinctions among them that impactboth their utility and their persistence.6,8

Collagens constitute more than 50% of the skin; theyare proteins that interact with cells and elements of theextracellular matrix, providing flexibility, elasticity, andstrength to the skin.9,10 Collagens can also be customizedinto various physical forms while retaining their tensilestrength, making them a logical choice for use in devicesdesigned to repair, restore, or augment soft tissues, suchas the skin. Collagens, being proteins, can be immuno-genic and, like those using HA, injectable devices usingunmodified collagen are also short-lived.5,11,12

Crosslinking is a process that generates bondsbetween monomeric units, thereby producing a materialthat has greater viscosity and structural integrity and ismore durable.12-14 The first collagen and the current HAdevices all use chemicals for crosslinking.11-13,15

However, extensive chemical crosslinking can make thematerial too rigid and reduce biocompatibility.16 Someconcerns have been raised regarding the possibility ofdelayed adverse immunologic events.17 In addition, ithas been suggested that toxicity may be common to alldevices using chemical crosslinking because of residualchemicals, 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 beenshown to be quite effective and generally safe. However,bovine collagens have a high incidence of allergies andthey require a pretreatment skin test20,21 and human colla-gens have all the safety issues inherent to using allogeneiccomponents. Clinical studies with HA-based dermal fillers(eg. Juvéderm [Allergan Inc., Santa Barbara, CA] andRestylane [Medicis Pharmaceutical Corp., Scottsdale, AZ])show that these implants are effective, exhibit a long dura-tion, and are generally safe,15,22,23 making them the cur-rent standard of treatment.

Advancements in injectable collagen and crosslinkingtechnologies enabled the development of a new device,Dermicol-P35 (Evolence [Ortho-Dermatologics, Skillman,NJ]), which uses porcine collagen crosslinked throughGlymatrix technology.24 This novel process crosslinks colla-gen fibers using glycation, a natural nonenzymatic reactionthat adds sugar moieties to proteins in order to generateintra- and intermolecular bridges.24 Glycation of collagenfibers is associated with increased heat stability and resist-ance to enzymatic degradation.25 The D-ribose glycationused to crosslink the porcine collagen fibers involved inmanufacturing Dermicol-P35 produces a device that has a3-dimensional structure akin to natural tissue. It is resistantto local enzymatic degradation, while providing an implantthat has a highly fibrous network permiting cell implanta-tion, structural and biochemical interaction with the sur-rounding tissue, and the reconstitution of lost volume.24

Clinical trials with this injectable device have shown itsutility for correcting nasolabial folds.24,26 Indeed, Dermicol-Dr. Bernard is in private practice in White Plains, NY.

S3-S4_YMAJ630_Bernard_CP:Layout 1 6/18/09 9:23 AM Page S3

S4 • Volume 29 • Number 3S • May/June 2009 Aesthetic Surgery Journal

P35 filler exhibits very good clinical performance whendirectly compared with a bovine collagen dermal filler24 orwith an HA dermal filler.26,27 Furthermore, the clinicaleffects of Dermicol-P35 implants have been shown to per-sist for at least 12 months, which is as long as HA-basedimplants.27,28 There do not appear to be any significantadverse events and patients appear to tolerate theseimplants quite well.24,26,27,29 Finally, unlike devices usingbovine collagen, Dermicol-P35 does not appear to require apretreatment skin test for hypersensitivity,20 thereby allow-ing a patient immediate access to treatment. It appears thatGlymatrix porcine collagen may circumvent the concernsthat have been raised regarding chemical crosslinking. Inthis special supplement to Aesthetic Surgery Journal, prac-ticing aesthetic surgeons and dermatologists provide briefreports on their clinical experiences in the use of Dermicol-P35 for dermal rejuvenation and/or restoration of the skinin various sites, including acne scars, cheeks, hands, lips,nose, and tear troughs. Although the total number ofpatients in these studies is small, these reports demonstratethe potentially wide utility and relative safety of this prod-uct. In the coming years, as both physicians and patientsgain greater experience in the use of this injectable device,we will see more definitively whether Dermicol-P35 livesup to its promising start in the field of dermal fillerimplants. ◗

ACKNOWLEDGEMENT

Editorial assistance was provided by Mukund Nori, PhD, MBA, ofEnvision Pharma, Southport, CT.

DISCLOSURES

The author is a consultant for Allergan. An honorarium wasoffered to Dr. Bernard for his role as Guest Editor of this supple-ment, but he declined it personally and generously asked that itinstead be donated to ASERF.

REFERENCES1. Makrantonaki E, Zouboulis CC. William J. Cunliffe scientific awards.

Characteristics and pathomechanisms of endogenously aged skin.Dermatology 2007;214:352–360.

2. Cox SE, Finn JC. Social implications of hyperdynamic facial lines andpatient satisfaction outcomes. Int Ophthalmol Clin 2005;45:13–24.

3. American Society for Aesthetic Plastic Surgery Web site. Cosmetic sur-gery national data bank: Statistics. (Accessed 11/10/2008, athttp://www.surgery.org/download/2007stats.pdf.)

4. American Society of Plastic Surgeons Web site. 2000/2006/2007 nation-al plastic surgery statistics: Cosmetic and reconstructive proceduretrends. (Accessed 12/2/2008, athttp://www.plasticsurgery.org/media/statistics/loader.cfm?url�/commonspot/security/getfile.cfm&PageID�29287.)

5. Klein AW. Soft tissue augmentation 2006: Filler fantasy. Dermatol Ther2006;19:129–133.

6. Green MS. Not all hyaluronic acid dermal fillers are equal. CosmeticDermatol 2007;20:724–729.

7. Tezel A, Fredrickson GH. The science of hyaluronic acid dermal fillers.J Cosmet Laser Ther 2008;10:35–42.

8. Rao J, Chi GC, Goldman MP. Clinical comparison between 2 hyaluronicacid-derived fillers in the treatment of nasolabial folds: Hylaform versusRestylane. Dermatol Surg 2005;31:1587–1590.

9. Cannas M, Bosetti M, Sabbatini M, Renò F. Role of extracellular matrixremodeling in advanced biocompatibility. In: Yaszemski MJ, TrantoloDJ, Lewandrowski K-U, Hasirci V, Altobelli DE, Wise DL, eds. TissueEngineering and Novel Delivery Systems. New York: Marcel Dekker,Inc.; 2004:1–30.

10. Leitinger B, Hohenester E. Mammalian collagen receptors. Matrix Biol2007;26:146–155.

11. Klein AW. Collagen substances. Facial Plast Surg Clin North Am2001;9:205–218.

12. Koide T. Designed triple-helical peptides as tools for collagen biochem-istry and matrix engineering. Phil Trans R Soc B 2007;362:1281–1291.

13. Falcone SJ, Berg RA. Crosslinked hyaluronic acid dermal fillers: A com-parison of rheological properties. J Biomed Mater Res A2008;87:264–271.

14. Friess W, Schlapp M. Effects of processing conditions on the rheologicalbehavior of collagen dispersions. Eur J Pharm Biopharm2001;51:259–265.

15. Baumann LS, Shamban AT, Lupo MP, et al. Comparison of smooth-gelhyaluronic acid dermal fillers with cross-linked bovine collagen: A mul-ticenter, double-masked, randomized, within-subject study. DermatolSurg 2007;33(Suppl 2):S128–S135.

16. Yang CH. Evaluation of the release rate of bioactive recombinanthuman epidermal growth factor from crosslinking collagen sponges. JMater Sci Mater Med 2008;19:1433–1440.

17. Alijotas-Reig J, Garcia-Gimenez V. Delayed immune-mediated adverseeffects related to hyaluronic acid and acrylic hydrogel dermal fillers:Clinical findings, long-term follow-up and review of the literature. J EurAcad Dermatol Venereol 2008;22:150–161.

18. Huang-Lee LL, Cheung DT, Nimni ME. Biochemical changes and cyto-toxicity associated with the degradation of polymeric glutaraldehydederived crosslinks. J Biomed Mater Res 1990;24:1185–1201.

19. Bauman L. CosmoDerm/CosmoPlast (human bioengineered collagen)for the aging face. Facial Plast Surg 2004;20:125–128.

20. Shoshani D, Markovitz E, Cohen Y, Heremans A, Goldlust A. Skin testhypersensitivity study of a crosslinked, porcine collagen implant foraesthetic surgery. Dermatol Surg 2007;33(Suppl 2):S152–S158.

21. Soo C, Rahbar G, Moy RL. The immunogenicity of bovine collagenimplants. J Dermatol Surg Oncol 1993;19:431–434.

22. DeLorenzi C, Weinberg M, Solish N, Swift A. Multicenter study of theefficacy and safety of subcutaneous non-animal-stabilized hyaluronicacid in aesthetic facial contouring: Interim report. Dermatol Surg2006;32:205–211.

23. Schweiger ES, Riddle CC, Tonkovic-Capin V, Aires DJ. Successfultreatment with injected hyaluronic acid in a patient with lip asym-metry after surgical correction of cleft lip. Dermatol Surg2008;34:717–719.

24. Monstrey SJ, Pitaru S, Hamdi M, et al. A 2-stage phase I trial ofEvolence30 collagen for soft-tissue contour correction. Plast ReconstrSurg 2007;120:303–311.

25. Paul RG, Bailey AJ. Glycation of collagen: The basis of its central rolein the late complications of ageing and diabetes. Int J Biochem Cell Biol1996;28:1297–1310.

26. Narins RS, Brandt FS, Lorenc ZP, et al. A randomized, multicenterstudy of the safety and efficacy of dermicol-p35 and non-animal-stabi-lized hyaluronic acid gel for the correction of nasolabial folds.Dermatol Surg 2007;33(Suppl 2):S213–S221.

27. Narins RS, Brandt FS, Lorenc ZP, Maas CS, Monheit GD, Smith SR.Twelve-month persistency of a novel ribose-crosslinked collagen dermalfiller. Dermatol Surg 2008;34(Suppl 1):S31–S39.

28. Pitaru S, Noff M, Blok L, et al. Long-term efficacy of a novel ribose-crosslinked collagen dermal filler: A histologic and histomorphometricstudy in an animal model. Dermatol Surg 2007;33:1045–1054.

29. Landau M. Lip augmentation and rejuvenation using a novel, porcinecollagen-derived filler. J Drugs Dermatol 2008;7:236–240.

Copyright © 2009 by The American Society for Aesthetic Plastic Surgery, Inc.

1090-820X/$36.00

doi:10.1016/j.asj.2009.01.012

S3-S4_YMAJ630_Bernard_CP:Layout 1 6/18/09 9:23 AM Page S4

http://www.surgery.org/download/2007stats.pdf

http://www.plasticsurgery.org/media/statistics/loader.cfm?url=/commonspot/security/getfile.cfm&PageID=29287

http://www.plasticsurgery.org/media/statistics/loader.cfm?url=/commonspot/security/getfile.cfm&PageID=29287

Full and high cheek bones are considered highlydesirable for facial attractiveness and are associatedwith youth.1 During the aging process, the soft tis-

sues of the face can suffer a loss of volume when subcu-taneous fat redistributes or diminishes.2 Factors that cancontribute to facial aging include diminished tissue elas-ticity, gravity, stress, and sun exposure.2 Cheek (malar)augmentation is a very popular procedure that can replacelost facial volume, enhance cheek prominence, improvefacial symmetry, and restore a youthful appearance.

Surgical procedures to enhance the cheek area includepermanent implantation of materials such as silicone.3

However, there are several disadvantages to permanentimplants, including the invasiveness of the procedure,infection, the potential displacement of implants, and theloss of sensation to the area.4 Therefore, for manypatients who are seeking an effective procedure toenhance their malar region but who also want to avoidthe potential problems of surgery, a minimally invasive,nonsurgical procedure is preferable. Nonsurgical optionsfor soft tissue contouring include autologous fat injec-tions (which require a separate preliminary harvestingprocedure)5 and injectable dermal fillers.

Dermal fillers in particular have become increasinglypopular among both patients and clinicians because theycan be used to restore volume and rejuvenate facial appear-ance with minimal discomfort to the patient.6 The idealdermal filler should be safe and nonpermanent, but last 1to 2 years, have low immunogenicity and low incidence ofadverse events, be easy to inject, and cause minimal painupon injection.7 Currently, there exist many dermal filleroptions, which can differ in material origin (biologic or syn-thetic) and longevity in the body (biodegradable or perma-nent).8 Biodegradable fillers include hyaluronic acid-basedand collagen-based fillers, both of which range in longevityfrom 3 months to 1 year,5 and calcium hydroxylapatite9

(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 andsilicone) can be difficult to remove and may be associatedwith a higher incidence of late complications, such asinflammatory nodules, vascular occlusion, and granulo-mas.5,10-12 Therefore, biodegradable fillers may be a betteroption for some patients, such as those receiving treatmentfor the first time.5

Injectable bovine collagen-derived dermal fillers(Zyderm and Zyplast; Allergan, Santa Barbara, CA) havebeen available for use in the correction of facial contourdefects since the 1980s.13 However, this material hasbeen associated with sensitivity in some patients andtherefore requires a skin test 4 weeks before treatment.5,8

In addition, this material generally provides shorter-termresults (3-5 months) compared with newer dermal fillersand it uses glutaraldehyde as a crosslinking molecule.5,14

Human collagen-based dermal fillers (Cosmoderm andCosmoplast; Inamed) are also available. These fillers donot require a skin test, but results from these productsare also shorter-term (3-5 months).5

Hyaluronic acid-based dermal fillers (includingRestylane and Perlane [Medicis Aesthetics, Scottsdale,AZ] and Juvéderm [Allergan, Santa Barbara, CA]) do notrequire a pretreatment skin test and provide longer-lasting results compared with bovine collagen–based der-mal fillers. In one clinical study, smooth gel hyaluronicacid dermal filler (Juvéderm) showed an improved per-sistence of results (>6 months) compared with a bovinecollagen-based dermal filler and was preferred by themajority of treated patients.15 For Restylane SubQ, benefi-cial results were reported to persist up to 64 weeks inpatients who received cheek augmentation.16 However, a2007 study by Alijotas-Reig et al17 reported that hyaluronicacid-based fillers may be associated with chronic inflam-matory and granulomatous adverse reactions.


Full and high cheekbones are considered a desirable component of facial attractiveness. The aging process canresult in a loss of facial volume and changes in facial contours. Cheek augmentation can replace lost facial vol-ume, 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 persist-ence of results in clinical trials. This article discusses the clinical experience of patients who received cheek aug-mentation with Dermicol-P35. (Aesthetic Surg J 2009;29:(( S5–S8.)

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

Cheek Augmentation With Dermicol-P35 27GNeil S. Sadick, MD; and Laura Palmisano, RPA-C

S5-S8_YMAJ657_Sadick_CP:Layout 1 6/24/09 3:20 PM Page S5

S6 • Volume 29 • Number 3S • May/June 2009

Recently, a new, highly purified, crosslinked, porcinecollagen-derived dermal filler Dermicol-P35 27G(Evolence [Ortho Dermatologics, Skillman, NJ]) hasbecome available. This filler is produced usingGlymatrix technology, a novel method of crosslinkingcollagen molecules using a natural sugar, D-ribose.18

Dermicol-P35 27G has proven efficacious for the treat-ment of nasolabial folds, with results persisting for atleast 12 months.18,19 Low immunogenicity was alsoreported; therefore, a skin test is not required beforethe procedure. Here we discuss our clinical experiencewith Dermicol-P35 27G in patients who received cheekaugmentation.

MATERIALS AND METHODSDermicol-P35 27G is suitable for patients desiring mild tomoderate cheek correction and is supplied in a sterile, pre-filled, 1-mL syringe with a 27-gauge needle (with either an0.5- or 1-inch needle). For some patients, injection with a30-gauge needle is preferable. Patients who are prone tobruising are instructed to avoid aspirin and nonsteroidalantiinflammatory drugs for 1 week prior to treatment.

Before treatment, our patients were photographedand patient consent was collected. To increase patientcomfort during injection, either a topical anesthetic(such as lidocaine) was applied to the injection site 30minutes before injection or 0.2 mL of lidocaine wasmixed into the syringe. Injection sites were marked andthe treatment area was cleaned with a topical antiseptic.The needle was inserted in 3 locations where the teartrough meets the zygomatic arch. The sites of injectionfor cheek augmentation are shown in Figure 1. The fillerwas injected in a retrograde fashion transdermally intothe mid-to-deep dermal layer (Figure 2) to provide struc-tural support. Injection techniques comprised a combi-nation of linear threading and vertical and horizontalcrosshatching. Once the treatment was complete, thecheek areas were slightly massaged and ice was appliedif necessary. Patients were instructed to apply ice ifswelling occurred and not to manipulate the area forseveral hours. Patients were evaluated immediately afterinjection and 1 week posttreatment.

RESULTSThe typical volumes of Dermicol-P35 27G administeredfor cheek augmentation are 1 mL (1 full syringe) percheek, but some patients may require more. The resultsare immediately visible to patients after injection. Themajority of patients experience little or no recovery timeand are able to resume their normal activities immedi-ately after the procedure. For the majority of patients,full correction is achieved in 1 visit.

In our clinical practice, patients have reported that theDermicol-P35 27G injection may be more painful than oth-er fillers. However, generally, minimal or no swelling orbruising is observed postinjection and at the first follow-upvisit. Patient satisfaction has been very high and patientsreturn for further treatments every 3 to 6 months to main-tain their results. Unlike results seen with some hyaluronicacid fillers, which can swell,20 we have not encounteredany cases of overcorrection with Dermicol-P35 27G.

Case ReportA 37-year-old woman presented with mild volume lossand desired a fuller, more youthful appearance to herface (Figure 3, A, C). One milliliter of filler was injectedCinto each cheek. She also elected to have filler injectedinto her chin. No swelling, bruising, or lumps wereobserved 1 hour posttreatment (Figure 3, B, D). Aftertreatment, her cheeks appeared fuller and more promi-nent and her overall appearance was more youthful.

DISCUSSIONSagging skin and the loss of facial fullness are commonconsequences of the aging process. Biodegradable der-mal fillers provide a practical, convenient, and effectivealternative to surgical cheek augmentation.21 To reducethe signs of facial aging, dermal fillers can replace sub-dermal malar fat, restore facial volume, and smooth theappearance of facial skin.

Dermicol-P35 27G is a new, porcine collagen-derivedbio degrad able dermal filler that has shown high patientsatisfaction and superior durability compared withbovine collagen filler in clinical trials.18 In addition, low-er incidences of bruising and swelling have been report-ed with porcine collagen dermal filler injectioncompared with hyaluronic acid-based fillers.22

Aesthetic Surgery JournalAesthetic Surgery Journal

Figure 1. Diagram of injection sites for cheek augmentation.

ArchZygomatic

Mid-pupil

sitesInjection

Teartrough

Figure 2. Placement of Dermicol-P35 27G within the dermal layer forcheek augmentation.

Dermicol-P35 27G


Volume 29 • Number 3S • May/June 2009 • S7Cheek Augmentation With Dermicol-P35 27G

Our clinical experience with Dermicol-P35 27G forthe purpose of cheek augmentation has been highlyfavorable. We have found that Dermicol-P35 27Gdemonstrates good tolerability, reproducible effects,and less bruising and swelling than other dermalfillers. Over the past year, our clinical results havebeen consistent with the results previously reportedfor Dermicol-P35 27G and our patients have consis-tently reported high satisfaction with their aestheticoutcomes. Because of their satisfaction with Dermicol-P35 27G, some patients have requested additionaltreatment after 3 to 6 months to further augment orenhance the prominence of their cheek region. Patientsdesiring maintenance treatment generally return after6 or more months.

CONCLUSIONDermicol-P35 27G is a newly available porcine colla-gen-based dermal filler for use in facial contour aug-

mentation. We have found that patients who haveundergone cheek augmentation with Dermicol-P3527G report minimal recovery time, a low incidence ofadverse events, little to no swelling or bruising imme-diately postinjection, and high satisfaction with theirresults. Therefore, Dermicol-P35 27G is a convenientand tolerable option for patients seeking to restorefacial volume and improve facial contours with a tem-porary dermal filler. ◗

ACKNOWLEDGMENT

The authors would like to acknowledge the assistance of RebeccaJarvis, PhD, of Envision Pharma (Southport, CT) in the prepara-tion of this manuscript.

DISCLOSURES

The author is a faculty member of the Evolence STAR Program andColbar LifeSciences.

A B

C D

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 injectionof 1 mL per cheek).



REFERENCES1. Sito G. Transoral injection of Restylane SubQ for aesthetic contouring of

the cheeks. Aesthetic Surg J 2006;26(Suppl 1):S22–S27.2. Coleman S, Grover R. The anatomy of the aging face: Volume loss and

changes in 3-dimensional topography. Aesthetic Surg J 2006;26(Suppl1):S4–S9.

3. Ivy EJ, Lorenc ZP, Aston SJ. Malar augmentation with siliconeimplants. Plast Reconstr Surg 1995;96:63–68.

4. The American Society for Aesthetic Plastic Surgery Web site. Cheekaugmentation. (Available at http://www.surgery.org/public/procedures/cheek_augmentation, accessed 12/7/2008.)

5. Narins RS, Bowman PH. Injectable skin fillers. Clin Plast Surg2005;32:151–162.

6. Busso M. Soft tissue augmentation: Nonsurgical approaches to treat-ment of the mid and lower facial regions. Dermatol Nurs2008;20:211–214, 217–219.

7. Tezel A, Fredrickson GH. The science of hyaluronic acid dermal fillers.J Cosmet Laser Ther 2008;10:35–42.

8. Cirillo P, Benci M, Bartoletti E, Bertana C. Proposed guidelines for useof dermal and subdermal fillers. G Ital Dermatol Venereol2008;143:187–193.

9. Sklar JA, White SM. Radiance FN: A new soft tissue filler. DermatolSurg 2004;30:764–768.

10. Salles AG, Lotierzo PH, Gemperli R, et al. Complications after poly-methylmethacrylate injections: Report of 32 cases. Plast Reconstr Surg2008;121:1811–1820.

11. Bagal A, Dahiya R, Tsai V, Adamson PA. Clinical experience with poly-methylmethacrylate microspheres (Artecoll) for soft-tissue augmenta-tion: A retrospective review. Arch Facial Plast Surg 2007;9:275–280.

12. Vedamurthy M. Standard guidelines for the use of dermal fillers. IndianJ Dermatol Venereol Leprol 2008;74(Suppl):S23–S27.

13. Cooperman LS, Mackinnon V, Bechler G, Pharriss BB. Injectable colla-gen: A six-year clinical investigation. Aesthetic Plast Surg1985;9:145–151.

14. Klein AW. Collagen substances. Facial Plast Surg Clin North Am2001;9:205–218.

15. Baumann LS, Shamban AT, Lupo MP, et al. Comparison of smooth-gelhyaluronic acid dermal fillers with crosslinked bovine collagen: A mul-ticenter, double-masked, randomized, within-subject study. DermatolSurg 2007;33(Suppl 2):S128–S135.

16. Lowe NJ, Grover R. Injectable hyaluronic acid implant for malar andmental enhancement. Dermatol Surg 2006;32:881–885.

17. Alijotas-Reig J, Garcia-Gimenez V. Delayed immune-mediated adverseeffects related to hyaluronic acid and acrylic hydrogel dermal fillers:Clinical findings, long-term follow-up and review of the literature. J EurAcad Dermatol Venereol 2008;22:150–161.

18. Monstrey SJ, Pitaru S, Hamdi M, et al. A two-stage phase I trial ofEvolence30 collagen for soft-tissue contour correction. Plast ReconstrSurg 2007;120:303–311.

19. Narins RS, Brandt FS, Lorenc ZP, Maas CS, Monheit GD, Smith SR.Twelve-month persistency of a novel ribose-cross-linked collagen der-mal filler. Dermatol Surg 2008;34(Suppl 1):S31–S39.

20. Belmontesi M, Grover R, Verpaele A. Transdermal injection of RestylaneSubQ for aesthetic contouring of the cheeks, chin, and mandible.Aesthetic Surg J 2006;26(Suppl 1):S28–S34.

21. Carruthers JD, Carruthers A. Facial sculpting and tissue augmentation.Dermatol Surg 2005;31(11 Part 2):1604–1612.

22. Narins RS, Brandt FS, Lorenc ZP, et al. A randomized, multicenterstudy of the safety and efficacy of Dermicol-P35 and non-animal-stabi-lized hyaluronic acid gel for the correction of nasolabial folds.Dermatol Surg 2007;33(Suppl 2):S213–S221.

Accepted for publication March 6, 2009.

Reprint requests: Neil S. Sadick, MD, FAAD, FACS, Sadick Dermatology,New York, NY 10075. E-mail: [email protected].


1090-820X/$36.00

doi:10.1016/j.asj.2009.03.004


http://www.surgery.org/public/procedures/cheek_augmentation


http://www.surgery.org/public/procedures/cheek_augmentation

The loss of volume in the face and the anterior dis-placement of the infraorbital fat, primarily caused bythe aging process, can lead to an unsightly depres-

sion in the suborbital region known as the tear trough.1,2

The tear trough has been defined as the hollow of themedial lower eyelid, bordered by the anterior lacrimalcrest and the inferior orbital rim.3,4 Tear trough deformi-ty can result in dark shadows under the eyes and afatigued appearance.3

The correction of tear trough deformity can be challeng-ing because the skin in this region lacks fat and thins withage. The proximity of the tear troughs to the eyes is also aconcern.2 Swelling and, rarely, blindness from intraarterialinjections are concerns when treating the tear trough.5,6

Options for tear trough augmentation have included bothsurgical (blepharoplasty) and nonsurgical methods, such asinjection of either autologous fat or one of the currentlyavailable dermal fillers. While surgery can be successful, itis also very invasive, has a long recovery time, and is sub-ject to a higher risk of complications than dermal fillers.5

The injection of autologous fat, while less prone to immuneresponses, requires harvesting this tissue from the patient,often requires a long time for recovery, and may produceresults that are lumpy.5,6

The use of a dermal filler to correct tear trough deformi-ty is minimally invasive and causes much less discomfortto the patient than a surgical procedure. While dermalfillers do not address the underlying causes of the teartrough deformity, they can restore volume and provide asmoother and more even appearance to the region.Permanent dermal fillers that are not biodegradable (eg. sil-icone and polymethylmethacrylate) are not recommended

for use in the tear trough region because they are micros-phere-based and may cause clumping.2

Several biodegradable dermal fillers, which can be clas-sified as semipermanent or temporary, are available foruse in tear trough augmentation.7 Semipermanentoptions, which can last for 1 to 2 years, include calciumhydroxylapatite (Radiesse/Radiance FN; BioForm Medical,San Mateo, CA) and poly-L-lactic acid (Sculptra; DermikLaboratories, Bridgewater, NJ). Temporary dermal fillerscan be either hyaluronic acid (HA)-based (Restylane[Medicis Aesthetics, Scottsdale, AZ] and Juvéderm[Allergan, Santa Barbara, CA]) or collagen-based (Zydermand Zyplast [Allergan, Santa Barbara, CA], and Dermicol-P35 [Ortho Dermatologics, Skillman, NJ].

Favorable results have been reported with the use ofHA-based dermal fillers in tear trough correction.5 Onepotential disadvantage that has been reported with HA-based dermal fillers is the Tyndall effect, characterized bya bluish-gray discoloration that can result from excessive-ly superficial placement of the filler.8,9 Bovine collagen–based dermal fillers such as Zyderm and Zyplast havealso been used in this region, but these dermal fillersgenerally have a shorter duration of effect compared withHA-based fillers.7 Localized hypersensitivity has beenassociated with bovine collagen–based dermal fillers,10

requiring a skin test 4 weeks before the procedure.11

Dermicol-P35 is a new, highly purified, porcine-basedcollagen dermal filler that produced by a novel crosslinkingof collagen molecules using a natural sugar, D-ribose.12

Clinical studies have found that Dermicol-P35 demonstrat-ed comparable efficacy for treating nasolabial folds tobovine collagen–based and HA-based products.12,13

Dermicol-P35 has also demonstrated persistence for up to12 months and low immunogenicity.12 A skin test is there-fore not required before the procedure. In this article, we


Deformity of the tear trough region, which can occur during the aging process, can result in dark shadows underthe eyes and a fatigued appearance. Augmentation of the tear trough is challenging because of the thin skinand lack of fat in the region. Adding volume to the tear trough region with a dermal filler is a nonsurgical pro-cedure with minimal discomfort to the patient. Dermicol-P35 (Evolence; Ortho Dermatologics, Skillman, NJ) isa new, ribose crosslinked, highly purified, porcine-based collagen filler that does not require prior skin testingand has shown improved persistence compared with bovine collagen-based dermal fillers. In this article, wepresent the clinical outcomes of patients who have received treatment with a novel ribose crosslinked porcinecollagen dermal filler for the correction of tear trough deformity. (Aesthetic Surg J 2009;29:S9–S11.(( )

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

Correction of Tear Trough Deformity With NovelPorcine Collagen Dermal Filler (Dermicol-P35)

David J. Goldberg, MD, JD

S9-S11_YMAJ652_Goldberg_CP:Layout 1 6/24/09 3:19 PM Page S9999S99999999S999


present the clinical experience and outcomes of patientswho have received treatment with Dermicol-P35 (Evolence)for the correction of tear trough deformity.

MATERIALS AND METHODSFemale patients presenting with tear trough deformitieswere injected with porcine collagen dermal filler. Subjectswere excluded if they had previous eyelid surgery or a his-tory of atopic dermatitis because patients with this condi-tion are highly susceptible to inflammatory responses (eg.inflammation of the lower eyelid).

After photographic documentation and informed con-sent, topical anesthetic was applied for 30 minutes beforetreatment. Dermicol-P35 (Evolence) was injected with a 30-gauge needle, predominantly at the level of the periosteum.

A 30-gauge needle allowed for more careful placement ofdermal filler with less trauma to the thin-skinned teartrough region. Dermal filler material was injected in a retro-grade fashion, wherein the needle is slowly withdrawn asthe material is injected. This allowed the majority of thefiller material to be injected at the periosteum, with smallamounts being injected in the subcutaneous and dermallevel. Such an approach provided for a blending and soften-ing of the clinical appearance. Magnifier/polarizing lenseswere worn by the injecting physician in an attempt to avoidvessels and thereby lessen the likelihood of injection-induced ecchymosis. The area was gently massaged afterinjection and cold compresses were applied to the area for5 minutes after the procedure. All subjects were followedfor 3 months after treatment and evaluated for both clinicaleffect and complications.

RESULTSA total of 10 female patients were treated for tear troughdeformities with Dermicol-P35. Patients ranged in agefrom 30 to 60 years. No patients had received any previ-ous tear trough treatments. Average total injected vol-umes 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 not-ed to have any posttreatment ecchymoses. Additionally, noTyndall effect was noted. All patients were able to resumenormal work and social activities immediately after treat-ment. At the 3-month follow-up visit, treatment resultswere persistent and patient satisfaction was high. In addi-tion, no complications were reported at this visit.

PatientsPatient 1. A 31-year-old female patient presented

with mild tear trough deformities and lower eyelidhyperpigmentation (Figure 1,A). No swelling or lumpi-ness was observed 1 day after treatment (Figure 1,B).After 3 months, the appearance of the tear troughs wasgreatly improved and the appearance of undereye shad-ows was diminished (Figure 1,C).C

Patient 2. A 55-year-old female patient showed teartrough deformity, with a thinned appearance to the lowereyelid skin and small angioma on the lower eyelid skin aswell (Figure 2,A). After 3 months, the quality of the lowereyelid skin was greatly improved and partial hiding of thevascular lesion was also achieved (Figure 2,B).

DISCUSSIONTreatment with Dermicol-P35 (Evolence) injectionimproved the appearance of tear trough deformity andreduced hyperpigmentation in all 10 treated patients. Unlikethe results reported with both autologous fat injections andpermanent dermal fillers,6 porcine collagen filler producedsmooth and even results. Adverse events and recovery peri-ods were minimal and all patients were able to resume nor-mal activities immediately after treatment. These results areconsistent with previous studies.13 Lastly, treatment effects


A

B

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.

C

S9-S11_YMAJ652_Goldberg_CP:Layout 1 6/24/09 3:19 PM Page S1011110S111110S11

Volume 29 • Number 3S • May/June 2009 • S11Correction of Tear Trough Deformity With Novel Porcine Collagen Dermal Filler

were found to persist for at least 3 months and all patientsreported high satisfaction with their results.

Tear trough deformities caused by aging can result inunsightly dark shadows under the eyes and a tiredappearance. Many patients elect to treat tear troughdeformities to restore a youthful appearance. While surgi-cal treatments are available, surgery is invasive, canrequire a lengthy recovery period, and has a higher riskof complications.6,14 Conversely, temporary dermal fillersoffer a minimally invasive and nonsurgical method toimprove the appearance of tear trough deformities withminimal discomfort and recovery time. They can restorevolume to the region, improve the appearance of hyper-pigmentation, and rejuvenate the facial appearance whencombined with a good injection technique.

CONCLUSIONDermicol-P35 (Evolence) is a new dermal filler that is avail-able for use in nonsurgical soft tissue augmentation. Theresults from these 10 treated patients indicate that Dermicol-P35 injection provides a convenient, effective, and minimal-ly invasive option for the correction of tear troughdeformities. Patients experienced minimal adverse eventsand reported high levels of satisfaction with their results. ◗

ACKNOWLEDGMENTS

The author would like to acknowledge the assistance of RebeccaJarvis, PhD, of Envision Pharma (Southport, CT) in the preparationof this manuscript.

DISCLOSURES

The author has no financial interest in products mentioned in this article.

REFERENCES1. Coleman SR, Grover R. The anatomy of the aging face: Volume loss

and changes in 3-dimensional topography. Aesthetic Surg J2006;26(Suppl 1):S4–S9.

2. Busso M. Soft tissue augmentation: Nonsurgical approaches to treatmentof the mid and lower facial regions. Dermatol Nurs 2008;20:211–214,217–219.

3. Sadick NS, Bosniak SL, Cantisano-Zilkha M, Glavas IP, Roy D. Definitionof the tear trough and the tear trough rating scale. J Cosmet Dermatol2007;6:218–222.

4. Bosniak S, Cantisano-Zilkha M, Purewal BK, Torres JJ, Rubin M,Remington K. Defining the tear trough. Ophthal Plast Reconstr Surg2007;23:254–255.

5. Kane MA. Treatment of tear trough deformity and lower lid bowing withinjectable hyaluronic acid. Aesthetic Plast Surg 2005;29:363–367.

6. Lambros VS. Hyaluronic acid injections for correction of the tear troughdeformity. Plast Reconstr Surg 2007;120(6 Suppl):74S–80S.

7. Vedamurthy M. Standard guidelines for the use of dermal fillers. IndianJ Dermatol Venereol Leprol 2008;74(Suppl):S23–S27.

8. Douse-Dean T, Jacob CI. Fast and easy treatment for reduction of theTyndall effect secondary to cosmetic use of hyaluronic acid. J DrugsDermatol 2008;7:281–283.

9. Hirsch RJ, Narurkar V, Carruthers J. Management of injected hyaluronicacid induced Tyndall effects. Lasers Surg Med 2006;38:202–204.

10. Keefe J, Wauk L, Chu S, DeLustro F. Clinical use of injectable bovinecollagen: A decade of experience. Clin Mater 1992;9:155–162.

11. Zyderm (bovine collagen implant) [package insert]. Fremont, CA:McGhan Medical Corp; 2000.


13. Narins RS, Brandt FS, Lorenc ZP, Maas CS, Monheit GD, Smith SR.Twelve-month persistency of a novel ribose-crosslinked collagen dermalfiller. Dermatol Surg 2008;34(Suppl 1):S31–S39.

14. Spector JA, Draper L, Aston SJ. Lower lid deformity secondary to auto-genous fat transfer: A cautionary tale. Aesthetic Plast Surg2008;32:411–414.

Accepted for publication February 27, 2009.

Reprint requests: David J. Goldberg, MD, JD, FAAD, Skin Laser and SurgerySpecialists of New York and New Jersey, 115 E. 57th St., Ste. 710, New York,NY 10022-2184. E-mail: [email protected].


1090-820X/$36.00

doi:10.1016/j.asj.2009.02.013

A B

Figure 2. A, Pretreatment view of a 55-year-old woman. B, Posttreatment view 3 months afterporcine collagen injection.

S9-S11_YMAJ652_Goldberg_CP:Layout 1 6/24/09 3:19 PM Page S11



Although a universal definition describing an idealpair of lips does not exist, a pair of proportionallyprojecting feminine lips is generally considered to

be sexually attractive.1 As one ages, the lips areinevitably subjected to predictable physical changes thatoften prompt women to seek lip augmentation and/orrejuvenation in an attempt to improve their appearance.Lip augmentation can be loosely defined as a procedureto enhance the fullness of lips. Lip rejuvenation refers toa procedure for the correction of lip lines, restoration ofthe contour and buttresses, and redirection of the droop-ing angles of the lips, all with the aim of reversing thechanges associated with aging.

In recent years, an increasing number of interventionshave been introduced that seek to improve the appear-ance of the lips. These include tissue or autologous fatgrafts, alloplastic implants, and surgical procedures onlip mucosa. The use of injectable fillers is the most com-mon technique for lip shape and volume enhancement.Two of the more popular injectable fillers are made fromhyaluronic acid (HA) or collagen, both of which are nat-ural constituents of the normal dermis.2

Collagen was one of the first fillers for aestheticenhancement and has been in use for more than 20 years.The results of lip shaping by collagen have always beenhighly appreciated aesthetically. However, because of therelatively short longevity of the results, the earlyinjectable collagen devices have been replaced by HA-based fillers for this indication. In its pure form, HA is anaturally occurring linear polysaccharide with a low riskof immunogenicity because of its lack of species or tissuespecificity. Studies on nonanimal, stabilized HA devices

such as Restylane (Medicis Pharmaceutical Corp.,Scottsdale, AZ) have shown favorable efficacy results anda low incidence of adverse events following injection.3,4

However, HA fillers are hygroscopic and these procedureson the lips are inevitably accompanied by bruising andswelling. More recent studies have also raised concernsover delayed adverse events relating to HA.5,6

Dermicol-P35 (Evolence; Ortho Dermatologics,Skillman, NJ) is a suspension of crosslinked, fibrillartype I collagen isolated from porcine tendons. Dermicol-P35 is considered more “human-like” and has not beenassociated with the same degree of immunogenicity asbovine collagen.7 The inter- and intramolecular cross-linking of collagen fibers in Dermicol-P35 fillers is pro-duced via D-ribose glycation, a naturally occurringnonenzymatic series of reactions between sugars andproteins.

This results in a product that exceeds the clinical per-formance of previous collagen-based devices andincludes advantages such as longevity, low immuno-genicity, easy injectability, natural-appearing results, anda lower rate of postinjection swelling and bruising.8

Dermicol-P35 30G is a newer formulation containingshorter collagen fibers that allow the product to flowthrough a smaller needle lumen. The major practical dif-ference between the 2 products is that Dermicol-P35 27Gis delivered through a 27-gauge needle, while Dermicol-P35 30G is delivered through a 30-gauge needle. Thisarticle focuses on the author’s clinical experience withpatients who underwent lip augmentation and rejuvena-tion procedures using Dermicol-P35 30G.

PATIENTS AND PROCEDURESLip augmentation and rejuvenation procedures usingDermicol-P35 30G were performed on 15 patients

Predictable changes in the lips caused by aging often prompt women to seek lip augmentation and/or rejuve-nation. This article describes the clinical experience of patients who underwent lip augmentation and rejuve-nation procedures using Dermicol-P35 30G (Evolence Breeze; Ortho Dermatologics, Skillman, NJ) a novel, D-ribose cross-linked, porcine collagen dermal filler. The majority of patients reported that the improvementafforded by Dermicol-P35 30G was either good or very good 3 months after their procedure, with minimaladverse effects. (Aesthetic Surg J 2009;29:S12–S15.(( )

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

Lip Augmentation and RejuvenationUsing Dermicol-P35 30G: PersonalExperiences From My ClinicMarina Landau, MD

S12-S15_YMAJ649_Landau_CP:Layout 1 6/24/09 3:19 PM Page S122221222222221222

Volume 29 • Number 3S • May/June 2009 • S13Lip Augmentation and Rejuvenation Using Dermicol-P35 30 G

(Table). The use of any anticoagulant or antiplateletmedication was prohibited before the procedures. Oralacyclovir (400 mg twice daily for 5 days) was adminis-tered to those with a previous history of herpes labialis.A thorough assessment of lip shape, volume, and condi-tion was performed before Dermicol-P35 30G injection.

The initial stages of the procedures on lips wereperformed under local anesthesia because the lips areone of the most sensitive areas of the face. Dermicol-P35 30G was mixed with a local anesthetic (0.3 mLlidocaine 1%) to render the injections more tolerableto patients. The mixture was performed through acommercially available female-to-female connectorunder strict aseptic conditions.

The results were assessed immediately after the pro-cedure, after 2 to 3 weeks, and after 3 months. Adverseevents were assessed by the physician up to 6 monthsafter the procedure.

RESULTSAs we have previously reported, 15 patients were includedin the study.9 All of the patients were women, with a meanage of 52.3 years (range 42-61 years). Nine patients under-went lip rejuvenation (with or without correction of thenasolabial folds) and 6 patients underwent lip augmenta-tion (with or without correction of the nasolabial folds;Table). The mean amount of Dermicol-P35 30G used perpatient was 1.4 mL (range 1.0-2.2 mL).

Three months after the procedures, 13 patients(86.7%) reported that the improvement afforded byDermicol-P35 30G was either good or very good and 2patients (13.3%) reported that the improvement was sat-isfactory. Only 3 patients who initially received a mini-

mal amount of filler (1 mL) required a touch-up 2 weeksafter the procedure.

The addition of 0.3 mL lidocaine 1% did not affect thelongevity or the efficacy of Dermicol-P35 30G. Contraryto cases where topical or regional pretreatment anesthe-sia was used, no distortion of the lip shape and volumeoccurred. Because swelling was minimal during the injec-tion, the final result was more visible and could be moreeasily appreciated by the physician and the patient.

In contrast to our previous experience with HA-baseddermal fillers, only minimal swelling on the lips was not-ed after injection with Dermicol-P35 30G. Transientlumps on the lips were reported, but spontaneouslycleared within 4 weeks after the procedure.

PatientsPatient 1. A 47-year-old woman (Figure 1) was

injected with 1.2 mL of Dermicol-P35 30G into the lowerand upper lips in order to enhance their volume and tocorrect the slight asymmetry in the shape of the rightpart of the lower lip. Immediate results were obtained,where more symmetric and pleasantly plump lips wereobserved. No swelling or bruising was noted.

Patient 2. A 42-year-old woman presented with anunsatisfactory appearance in the shape of her lips,mainly because of the upper lip, which lacked volume.Lip augmentation to correct the volume and redefinethe vermillion border of the lip was performed with1.0 mL of Dermicol-P35 30G. A comparison made onphotographs taken before and after the procedure(Figure 2) shows that the philtral columns were suc-cessfully reconstructed, which makes the upper liplook pleasantly shorter.

Table. Patient demographics and satisfaction after procedure

Patient satisfaction Touch-up Amount of Nasolabial Patient no. at 3 months in 2 weeks filler, mL correction Indication Age, y Sex

1 Very good – 1.0 – Augmentation 42 F

2 Very good – 1.5 – Rejuvenation 57 F

3 Good + 1.0 – Rejuvenation 60 F

4 Very good – 2.0 + Rejuvenation 55 F



7 Good – 2.0 + Rejuvenation 59 F

8 Good – 1.0 – Augmentation 43 F

9 Satisfactory + 1.0 + Augmentation 44 F





14 Satisfactory – 1.2 – Augmentation 47 F


F, Female.FF



Patient 3. A 57-year-old patient with upper lip wrin-kles and blurred vermilion border of both lips wasinjected with 1.0 mL of Dermicol-P35 30G. Threemonths after the procedure, an almost absolute disap-pearance of the wrinkles was noted. The postprocedurephotograph clearly shows that a redefinition of the ver-milion border rejuvenated the patient’s appearance.

DISCUSSIONInjectable fillers for dermal contour corrections originatedwith the introduction of Zyderm and Zyplast (McGhanMedical Corp., Fremont, CA)10 injectable bovine collagenin the United States in 1981.9 These agents opened up thepossibilities for lip augmentation and rejuvenation to cre-ate a fuller appearance. Since the mid-1990s, HA-basedfillers have provided an additional option to the physi-cian. As mentioned above, the continuing use of HA-based fillers, especially on the lips, is limited by thebruising and swelling that occur after injection.

The ideal injectable filler for immediate correction ischaracterized by a long-term persistency and a lowoccurrence of adverse events or complications.11 The useof bovine injectable collagens was limited because of thehigh incidence of allergies and the need for a pretreat-ment skin test, as well as their limited duration of clinicalcontour correction. Although human-sourced collagenssuch as CosmoDerm and CosmoPlast (Allergan, SantaBarbara, CA) may circumvent the need for skin tests, theuse of glutaraldehyde-based crosslinking technology lim-its the extent of crosslinking that can be achieved and thenature of the crosslinks formed.11,12

The deficiencies of earlier collagen-based fillers aremostly resolved by the introduction of Dermicol-P35filler. The inter- and intramolecular cross-linking of col-lagen fibers in Dermicol-P35 filler are generated via gly-cation, which results in a product that is resistant tolocal enzymatic degradation.12 In addition, a pretreat-ment skin test is unnecessary and the occurrence of

A B

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 Dermicol-P35 30G into the lower and upper lips.

A B

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 30Ginto the upper lip.



A B

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-P3530G into both lips.

hypersensitivity is minimal.13 The sugar-based cross-linkers used to produce Dermicol-P35 also result in astructure with enhanced integrity and strength, whichcould lead to higher persistency in areas that are subject-ed to corrections.

Based on the experience garnered during this study,Dermicol-P35 30G was found to be especially efficient inthe treatment of small upper lip wrinkles (Figure 3). Ourexperience has shown that these wrinkles are extremelychallenging and cannot be efficiently eliminated usingHA-based fillers without some swelling of the upper lipskin or linear ridges along the injection lines. On thecontrary, the use of Dermicol-P35 30G in the lip regionproduced relatively minimal swelling and bruising. Thisrendered the procedure more acceptable and the imme-diate results could be more easily appreciated. Thelongevity of the results in the lips was another importantadvantage of this filler.

The advantages of Dermicol-P35 when compared withprevious collagen-based fillers were successfully shown inclinical trials.8 The satisfaction expressed by the majorityof patients in this study further supported the remarkableeffectiveness and safety of Dermicol-P35 30G when usedin lip augmentation and rejuvenation procedures.

CONCLUSIONSThe use of Dermicol-P35 30G for lip augmentation andrejuvenation is associated with a high degree of clinicianand subject satisfaction. There were minimal and mostlymild adverse events that resolved quickly. ◗

ACKNOWLEDGMENT

Editorial support was provided by Keni CS Lee, PhD, and MukundNori, PhD, MBA, of Envision Pharma, Southport, CT.

DISCLOSURES

The author speaks for Johnson & Johnson occasionally duringCongresses, presenting her own clinical experience with their product.

REFERENCES1. Sutter RE Jr, Turley PK. Soft tissue evaluation of contemporary

Caucasian and African American female facial profiles. Angle Orthod1998;68:487–496.

2. Carruthers JD, Glogau RG, Blitzer A, Facial Aesthetics ConsensusGroup Faculty. Advances in facial rejuvenation: Botulinum toxin typeA, hyaluronic acid dermal fillers, and combination therapies—consen-sus recommendations. Plast Reconstr Surg 2008;121(5 Suppl):5S–30S.

3. Olenius M. The first clinical study using a new biodegradable implantfor the treatment of lips, wrinkles, and folds. Aesthetic Plast Surg1998;22:97–101.

4. Duranti F, Salti G, Bovani B, Calandra M, Rosati ML. Injectablehyaluronic acid gel for soft tissue augmentation. A clinical and histo-logical study. Dermatol Surg 1998;24:1317–1325.

5. Lowe NJ, Maxwell CA, Lowe P, Duick MG, Shah K. Hyaluronic acidskin fillers: Adverse reactions and skin testing. J Am Acad Dermatol2001;45:930–933.

6. Lupton JR, Alster TS. Cutaneous hypersensitivity reaction to injectablehyaluronic acid gel. Dermatol Surg 2000;26:135–137.

7. Nir E, Goldlust A, Shoshani D, Azachi M. Long-term in vivo evaluationof the safety and efficacy of a new porcine collagen dermal filler cross-linked with ribose [abstract]. J Am Acad Dermatol 2008;58:AB63.



10. Klein AW. Indications and implantation techniques for the various for-mulations of injectable collagen. J Dermatol Surg Oncol 1988;14(Suppl 1):27–30.



13. Shoshani D, Markovitz E, Cohen Y, Heremans A, Goldlust A. Skin testhypersensitivity study of a cross-linked, porcine collagen implant foraesthetic surgery. Dermatol Surg 2007;33(Suppl 2):S152–S158.

Accepted for publication January 23, 2009.

Reprint requests: Marina Landau, MD, Joshua Ben Nun St., 56 HerzliyaPituach, Israel 46763. E-mail: [email protected].


1090-820X/$36.00

doi:10.1016/j.asj.2009.02.010




Acne vulgaris is a prevalent skin condition that canafflict men and women, generally beginning inthe teen years. A common complication of acne is

disfiguring residual scarring. Facial acne scars can havea devastating impact on self-esteem and quality of lifefor many acne sufferers.1 Acne scars are predominantlyatrophic and can be classified as rolling, ice pick or pit-ted, and deep or shallow boxcar.2

While the complete removal of acne scars is unlike-ly, there exist a variety of treatments that can lessentheir appearance.3 These include wire brush dermabra-sion, laser resurfacing treatment, ablative fractionallaser resurfacing, surgery (such as punch incision), andinjected soft tissue fillers.2,4 Surface techniques can beespecially useful for shallow scars, but dermal fillersmay provide a better option for depressed scars.Dermal fillers offer a simple, nonsurgical correctiveoption that can improve skin texture and appearance.However, limited benefits have been observed with icepick scars.3 Ideally, dermal fillers used for acne scartreatment should provide lasting results and shouldnot induce further skin inflammation or the formationof granulomas.5

Several types of dermal fillers have been explored foruse in acne scar treatment. Biodegradable fillers includetemporary fillers, such as collagen-based (Zyderm[Allergan, Santa Barbara, CA])6 and hyaluronic acid–based (Restylane [Medicis Aesthetics, Scottsdale, AZ] andJuvéderm [Allergan, Santa Barbara, CA])7 fillers, as wellas semipermanent fillers, such as calcium hydroxylap-atite gel5 (Radiesse [BioForm Medical, San Mateo, CA])and poly-L-lactic acid (Sculptra [Dermik Laboratories,Bridgewater, NJ]).8 Permanent filler options include sili-cone fillers3 and polymethymethacrylate combined

with bovine collagen (Artefill [Artes Medical, SanDiego, CA]).4

Treatment with bovine collagen dermal filler hasresulted in the improved appearance of soft scars, but noimprovements in the appearance of ice pick scars.6

Similarly, the appearance of saucerized scars was foundto improve with calcium hydroxylapatite treatment, butminimal or no improvement was observed for ice pickscars.5 Silicone microdroplet treatment has shown bene-fits for correcting broad-based depressed scars, withresults lasting up to 30 years.3

Bovine collagen dermal fillers have demonstrated effi-cacy, but are associated with sensitivity in some patients,require a pretreatment skin test, and provide shorter-termresults than other dermal fillers.9 Dermicol-P35 (Evolence[Ortho Dermatologics, Skillman, NJ]) is a new, highlypurified, porcine collagen–based dermal filler that hasdemonstrated low immunogenicity and therefore doesnot require a prior skin test.10 It is produced using thenovel Glymatrix technology, which uses a natural sugar,D-ribose, to crosslink collagen molecules instead of apotential toxin, such as glutaraldehyde.11 In addition,results of Dermicol-P35 have been shown to persist for atleast 12 months.10 This article presents the results of amale patient treated with Dermicol-P35 for the correctionof severe facial acne scarring.

PATIENT AND PROCEDURES

Case StudyA 45-year-old male in good health with no comorbidconditions presented with facial scarring (a mixture ofdepressed scars and some ice pick scars on both cheeks)resulting from severe acne (Figure 1A, B). The patienthad not received any previous acne scar treatment witha dermal filler. No topical anesthetic or ice was usedbefore injection. Dermicol-P35 was supplied as a single-use, prefilled sterile syringe.

Acne vulgaris is a prevalent skin condition that can cause disfiguring residual scarring. While the completeremoval 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 collagen–based dermal filler that has demonstrated low immunogenicity and results that persist for atleast 12 months. This article presents the aesthetic results of a male patient treated with Dermicol-P35 forsevere facial acne scars. (Aesthetic Surg J 2009;29:S16–S18.(( )

From the Niagara Falls Dermatology and Skin Care Center,Niagara Falls, Ontario, Canada.

Repair of Acne Scars With Dermicol-P35Kevin C. Smith, MD

S16-S18_YMAJ653_Smith_CP:Layout 1 6/24/09 3:18 PM Page S1666

Volume 29 • Number 3S • May/June 2009 • S17Repair of Acne Scars With Dermicol-P35

At each visit, before collagen filler injection, the scarsto be treated were marked and intradermal injections ofnormal saline were administered using a 1-mL insulinsyringe (BD-II; Becton Dickinson, Franklin Lakes, NJ)with attached 30-gauge 8-mm needle. Each saline injec-tion of 0.1 to 0.2 mL raised a hard wheal and causedhydrostatic dissection of the scar tissue. Injection dis-comfort was reduced by the local anesthetic effect of0.9% benzyl alcohol preservative in the normal salinesolution.

Approximately 2 minutes after the saline injection,0.05 to 0.1 mL of Dermicol-P35 was injected into the

mid dermis of each scar, using a 30-gauge half-inch nee-dle. To further reduce injection discomfort, 0.15 mL of2% lidocaine without epinephrine was mixed into eachsyringe of dermal filler. After each Dermicol-P35 injec-tion, the treated area was immediately massaged toensure proper placement of the filler. Improvementswere monitored by referring to pretreatment photos tak-en under standardized oblique lighting conditions.

RESULTSThe patient underwent 2 treatment sessions, with a doseof 1 mL (1 syringe) injected at each treatment session.

A B

C D

E F

Figure 1. A, B, Pretreatment view of a 45-year-old male with facial acne scars immediately before injections. C, D, One month posttreatment with1 mL of Dermicol P-35. These photos were taken immediately prior to this patient’s second treatment. E, F, Two months after the first treatmentand one month after the second treatment. The total cumulative dose of Dermicol P-35 was 2 mL.



The injection procedure was well-tolerated. Results wereapparent immediately after each procedure, there was nodown time, and there were no complaints of bruising orpostprocedure discomfort. At the 1-month follow-up vis-it, the appearances of depressed scars and skin texturewere still visibly improved (Figure 1C, D). Ice pick scarswere still visible. No bruising, swelling, or granulomaswere observed at this visit. The patient was so pleasedthat an additional 1 mL treatment was administrated atthe 1-month follow-up visit. At the 2-month follow-upvisit, after a total of 2 mL of Dermicol-P35 had beeninjected over 2 sessions, the appearance of the depressedacne scars was greatly diminished (Figure 1E, F). TheFcontour of the face was also smoother and greatlyimproved in the treated areas. Ice pick scars were stillvisible, but their appearance was minimized. There wereno adverse events, no down time reported, and thepatient was highly satisfied with his aesthetic outcome.

DISCUSSIONSevere facial acne can result in unsightly and permanentscarring. Dermal fillers offer a minimally invasive, non-surgical option for the correction of acne scars.Dermicol-P35 (Evolence) is a new dermal filler that hasbeen shown to provide results lasting longer than 12months and has low immunogenicity. The case reportedin this article demonstrates the effectiveness of usingDermicol-P35 for the treatment of severe atrophic acnescarring. Dermicol-P35 administered immediately afterdistention of the scars with saline produced a highdegree of correction, with no papules or other adverseevents and high patient satisfaction. While the acnescars were not completely removed, their appearance(along with overall skin texture) was greatly improved.

CONCLUSIONDermicol-P35 was used to reduce the appearance ofacne scars in a male patient. After 2 treatments withDermicol-P35, acne scars were visibly diminished andskin texture was greatly improved. ◗

ACKNOWLEDGMENTS

The author would like to acknowledge the editorial assistance ofRebecca Jarvis, PhD, of Envision Pharma (Southport, CT) in thepreparation of this manuscript.

DISCLOSURES

The author has received research support and served as a consult-ant and speaker for Johnson & Johnson.

REFERENCES1. Loney T, Standage M, Lewis S. Not just ‘skin deep’: Psychosocial effects

of dermatological-related social anxiety in a sample of acne patients. JHealth Psychol 2008;13:47–54.

2. Alam M, Dover JS. Treatment of acne scarring. Skin Therapy Lett 2006Dec-2007 Jan;11:7–9.

3. Barnett JG, Barnett CR. Treatment of acne scars with liquid siliconeinjections: 30-year perspective. Dermatol Surg 2005;31(11 Pt 2):1542–1549.

4. Rivera AE. Acne scarring: a review and current treatment modalities.J Am Acad Dermatol 2008;59:659–676.

5. Goldberg DJ, Amin S, Hussain M. Acne scar correction using calciumhydroxylapatite in a carrier-based gel. J Cosmet Laser Ther 2006;8:134–136.

6. Varnavides CK, Forster RA, Cunliffe WJ. The role of bovine collagen inthe treatment of acne scars. Br J Dermatol 1987;116:199–206.

7. Vedamurthy M. Soft tissue augmentation—Use of hyaluronic acid asdermal filler. Indian J Dermatol Venereol Leprol 2004;70:383–387.

8. Sadove R. Injectable poly-L-lactic acid: A novel sculpting agent for thetreatment of dermal fat atrophy after severe acne. Aesthetic Plast Surg2009;33:113–116.

9. Narins RS, Bowman PH. Injectable skin fillers. Clin Plast Surg2005;32:151–162.


11. Pitaru S, Noff M, Blok L, et al. Long-term efficacy of a novel ribose-cross-linked collagen dermal filler: A histologic and histomorphometricstudy in an animal model. Dermatol Surg 2007;33:1045–1054.

Accepted for publication February 27, 2009.

Reprint requests: Kevin C. Smith, MD, FRCPC, Niagara Falls Dermatologyand Skin Care Center, Ltd., 201-6453 Morrison St., Niagara Falls, ON,Canada L2E 7H1. E-mail: [email protected].


1090-820X/$36.00

doi:10.1016/j.asj.2009.02.014



Next to the face, the hands are the most visiblepart of the body.1 In addition to their utilitarianpurposes, hands are also very important for both

interpersonal interactions and contact.1 As such, it isimportant that hands maintain their appearance.2 Thisattitude is reflected in studies about patients’ opinionson hand aging.3 Nevertheless, aesthetic hand rejuvena-tion and restoration have been relatively overlookedcompared 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 definitionof an ideal hand. Still, there seems to be some agree-ment on the general characteristics that should defineaesthetically pleasing hands, including size proportions,the extent and nature of the soft tissue, the characteris-tics of the palm, and the quality of the nails.3

As people age, the hand undergoes physical changescaused by intrinsic factors (such as a decrease in skinelasticity and soft tissue atrophy)4-6 and extrinsic factors(such as exposure to light).7,8 Several approaches tohand rejuvenation have been documented, includingtopical agents (such as creams) to reduce signs of pho-toaging, microdermabrasion for superficial restorationand rejuvenation of the skin, chemical peels to removethe upper layer of dead skin, various forms of photother-apy, and fat augmentation.4 While each method has metwith some degree of success, some of these proceduresinvolve injuring the epidermis.4,9 Fat augmentation doesnot injure the epidermis, but it often results in prolongededema.4 There is clearly an unmet medical need for newtechnologies in aesthetic hand rejuvenation.

The introduction of cosmetic dermal fillers has provid-ed physicians and patients with new options for treatingthe aging and damaged hand.10,11 Such devices largely fallinto 2 categories: those that are hyaluronic acid–based

and those that are collagen-based. The latter category canbe further divided into those that use human collagen(CosmoDerm and CosmoPlast [Allergan, Santa Barbara,CA]),12 those that use bovine collagen (Zyderm andZyplast Allergan, Santa Barbara, CA),13 and those thatuse porcine collagen (Dermitol-P35 30G; Evolence Breeze[Ortho Dermatologics, Skillman, NJ]).14 The collagen inEvolence is crosslinked with D-ribose through novelGlymatrix technology that allows the implant to be effec-tive for a long duration with minimal adverse eventswhen injected into nasolabial folds.15-17 Furthermore,unlike bovine collagen, Dermicol-P35 30G does notrequire a skin test.18 In this paper, I present some of myclinical experiences using Dermicol-P35 30G for rejuvena-tion and restoration of the hand.

PATIENTS AND PROCEDURESTwelve patients (10 women and 2 men) who desired anatural looking, youthful improvement in their dorsalhand appearance were treated. Dermicol-P35 30G is sup-plied as a sterile, 1-mL, single-use syringe with a 30-gauge needle. Before treatment, each patient’s medicalhistory was collected and each underwent a full consul-tation and physical examination. Patients’ hands wereassessed for skin elasticity, photoaging, volume loss,atrophy, and prominence of dorsal veins and tendons.After informed consent was obtained and pretreatmentphotographs were taken, topical local anesthetic creamwas applied to the hand 20 to 30 minutes before injec-tion. The skin was also cleaned with a topical antisepticbefore injection. Dermicol-P35 30G was injected subcu-taneously, either by serial puncture or linear threadingtechnique, as appropriate. Firm massage was performedfollowing injection to ensure a smooth result. After treat-ment, the patients were instructed to avoid vigorous useof their hands for 24 hours. Normal hand washing wasallowed and patients were instructed to elevate the handif swelling was evident.


Aesthetic hand rejuvenation and restoration have been relatively overlooked compared with other aestheticenhancements. Cosmetic dermal fillers provide physicians and patients with a nonsurgical option for restoringvolume and a youthful appearance to the aging and damaged hand. This paper presents the clinical experi-ence of patients who received Dermicol-P35 30G (Evolence Breeze; Ortho Dermatologics, Skillman, NJ) injec-tion for rejuvenation and restoration of the hand. (Aesthetic Surg J 2009;29:S19–S21.(( )

The author is in private practice in London, United Kingdom.

Nonsurgical Hand Rejuvenation WithDermicol-P35 30G

Christopher Inglefield, BSc, MBBS

S19-S21_YMAJ661_Ingle_CP:Layout 1 6/24/09 3:18 PM Page S1999


Patient satisfaction was rated on a scale of 0 (defined asno improvement, or low patient satisfaction) to 4 (definedas significant improvement, or high patient satisfaction). Aposttreatment assessment was performed at 4 weeks, withoptional touch-up treatment. Additional follow-up visitswere scheduled at both 8 and 12 weeks. Adverse eventswere assessed for 3 months following the procedure.

RESULTSTwelve patients (a total of 24 hands) received hand aug-mentation treatment with Dermicol-P35 30G dermalfiller. Patients ranged in age from 21 to 53 years (mean41.5 years). An average of 1.2 mL of Dermicol-P35 30Gwas injected into each hand.

Patients were followed for 8 to 24 weeks (mean 15.6weeks). Clinical cosmetic results were maintained in 22 of24 hands until at least the 3-month follow-up visit. Patientsreported high satisfaction with the results of their treat-ment. The mean patient satisfaction score was 3.7; patientswere “very satisfied” with 23 of 24 hands and “satisfied”

with 1 of 24 hands. Minimal to no swelling was evident forall patients 24 hours postinjection. No cases of allergic reac-tion, infection, or lumps were observed. Mild discomfortlasting 24 to 48 hours was reported by some patients. Allpatients returned to normal activities after 24 hours. Minorbruising was observed in 2 out of 12 patients.

PatientsThe 2 patients featured here were injected withDermicol-P35 30G to improve hand appearance byrestoring lost hand volume and reducing the prominenceof dorsal tendons and joints. Greatly improved handappearance was maintained at least 8 weeks postinjec-tion. Tendons and joints were less prominent and thehands appeared smoother and more youthful. Beforeand immediately after treatment, photographs were tak-en of a 54-year-old woman injected with 1.5-mL of fillerin each hand (Figure 1). Similarly, photographs weretaken of a 38-year-old man before and immediately aftertreatment with 3.5 mL of filler in each hand (Figure 2).


A B

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.

A B

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.


Volume 29 • Number 3S • May/June 2009 • S21Nonsurgical Hand Rejuvenation With Dermicol-P35 30G

DISCUSSION

While the appearance of the skin on aging hands can beimproved with surface treatments such as chemical peel-ing, bleaching, laser resurfacing, and microdermabrasion,these methods do not address the loss of volume that canoccur with age.4 Patients seeking to restore hand volumehave been limited primarily to autologous fat injection.Fat injections require a separate harvesting procedure andcan produce lumpy results. While the duration of efficacyfor fat injections has been shown to be longer, the fatinjection procedure can result in complications, includinginfection and marked postoperative edema.4 Recently,dermal fillers have been explored as a potential nonsurgi-cal alternative to fat injections. A study published lastyear comparing the efficacies of dermal fillers containinghuman collagen (CosmoPlast) and hyaluronic acid(Restylane [Medicis Aesthetics, Scottsdale, AZ]) showedthat although injections with the latter were more painfulto the patient, they provided superior aesthetic efficacy inimproving the appearance of the hand than did injectionswith human collagen.19

In clinical trials, Dermicol-P35 30G porcine colla-gen dermal filler has demonstrated low immunogenic-ity and persistence of results lasting at least 12months.17,18 We found that Dermicol-P35 30G was effi-cacious at restoring hand volume and reducing theprominence of dorsal veins and tendons, therebygreatly improving hand appearance. Dermicol-P35 30Gappears to be well tolerated, with patients reportingonly mild adverse events. Results were maintained forat least 3 months and patients reported high satisfac-tion. While further study is necessary, based on ourclinical experience, Dermicol-P35 30G provides apromising option for patients considering nonsurgicaldorsal hand augmentation.

CONCLUSIONDermicol-P35 30G is a newly available porcine collagen-based dermal filler for use in nonsurgical soft tissue aug-mentation. Patients who have undergone treatment withDermicol-P35 30G for the correction of hand deformitiesand/or aging experienced minimal adverse events andreported satisfaction with their results. ◗

ACKNOWLEDGMENTS

The author acknowledges the editorial assistance provided byMukund Nori, PhD, MBA, and Rebecca Jarvis, PhD, of EnvisionPharma, Inc (Southport, CT) in the preparation of this manuscript.

DISCLOSURES

The author has no financial interest in manufacturers of productsmentioned in this article.

REFERENCES1. Goldman A, Prati C, Rossato F. Hand rejuvenation using intense pulsed

light. J Cutan Med Surg 2008;12:107–113.2. Jakubietz RG, Jakubietz MG, Kloss D, Gruenert JG. Defining the basic

aesthetics of the hand. Aesthetic Plast Surg 2005;29:546–551.

3. Bains RD, Thorpe H, Southern S. Hand aging: Patients’ opinions. PlastReconstr Surg 2006;117:2212–2218.

4. Butterwick KJ. Rejuvenation of the aging hand. Dermatol Clin2005;23:515–527, vii.

5. Tzaphlidou M. The role of collagen and elastin in aged skin: An imageprocessing approach. Micron 2004;35:173–177.

6. Uitto J. The role of elastin and collagen in cutaneous aging: Intrinsicaging versus photoexposure. J Drugs Dermatol 2008;7(2Suppl):S12–S16.

7. Giacomoni PU, Rein G. A mechanistic model for the aging of humanskin. Micron 2004;35:179–184.

8. Jakubietz RG, Kloss DF, Gruenert JG, Jakubietz MG. The ageing hand.A study to evaluate the chronological ageing process of the hand. JPlast Reconstr Aesthet Surg 2008;61:681–686.

9. Aust MC, Reimers K, Repenning C, et al. Percutaneous collagen induc-tion: Minimally invasive skin rejuvenation without risk of hyperpig-mentation-fact or fiction? Plast Reconstr Surg 2008;122:1553–1563.

10. Broder KW, Cohen SR. An overview of permanent and semipermanentfillers. Plast Reconstr Surg 2006;118(3 Suppl):7S–14S.

11. Engelman DE, Bloom B, Goldberg DJ. Dermal fillers: Complicationsand informed consent. J Cosmet Laser Ther 2005;7:29–32.

12. Bauman L. Cosmoderm/Cosmoplast (human bioengineered collagen)for the aging face. Facial Plast Surg 2004;20:125–128.

13. Klein AW. Collagen substances. Facial Plast Surg Clin North Am2001;9:205–218, viii.


15. Narins RS, Brandt FS, Lorenc ZP, et al. A randomized, multicenterstudy of the safety and efficacy of Dermicol-p35 and non-animal-stabi-lized hyaluronic acid gel for the correction of nasolabial folds.Dermatol Surg 2007;33(Suppl 2):S213–221.

16. Pitaru S, Noff M, Blok L, et al. Long-term efficacy of a novel ribose-crosslinked collagen dermal filler: A histologic and histomorphometricstudy in an animal model. Dermatol Surg 2007;33:1045–1054.

17. Narins RS, Brandt FS, Lorenc ZP, et al. Twelve-month persistency of anovel ribose-crosslinked collagen dermal filler. Dermatol Surg2008;34(Suppl 1):S31–S39.


19. Man J, Rao J, Goldman M, A double-blind, comparative study ofnonanimal-stabilized hyaluronic acid versus human collagen for tissueaugmentation of the dorsal hands. Dermatol Surg 2008;34:1026–1031.


Reprint requests: Christopher Inglefield, BSc, MBBS, FRCS (Plast), LondonBridge Plastic Surgery, 13 Tooley St., London SE1 2PE, United Kingdom. E-mail: [email protected].


1090-820X/$36.00

doi:10.1016/j.asj.2009.03.008




The aging process affects the physical appearanceof the face, including the nose. Usually, the tip ofthe nose begins to droop because of the loss of

subcutaneous tissues, which further exacerbates thevisual impact of aging. Increasingly, patients undergoingmarionette line corrections and lip augmentations arealso considering nose augmentation to achieve a morebalanced overall improvement of the face. Although theimprovement afforded by traditional rhinoplasty is well-established, it remains a costly and invasive procedurethat takes time to heal and may lead to scarring.1,2

The use of injectable dermal filler for nose augmentationor secondary rhinoplasty is gaining popularity because ofits minimally invasive nature and quasi-immediate effectfollowing the procedure.3 Two of the most popular dermalfillers 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 oflongevity and were subsequently replaced by HA-basedfillers. Pure HA is a naturally occurring linear polysac-charide that poses minimal risk of immunogenicity.Rhinoplasty augmentation and reconstruction trialsusing HA have shown favorable safety and efficacyresults.3,5,6 Because of the hygroscopic nature of HAfillers, bruising and swelling remain possible side effects.Some recent studies have also raised concerns over thedelayed adverse events associated with HA.5,6

Glymatrix collagen filler Dermicol-P35 (Evolence[Ortho Dermatologics, Skillman, NJ]) is a suspension ofcrosslinked, fibrillar type I collagen isolated from porcinetendons. Dermicol-P35 is considered more “human-like”and has not been associated with the same degree of

immunogenicity as bovine collagen.7 The inter- andintramolecular crosslinking of collagen fibers inDermicol-P35 fillers are produced via D-ribose glycation,a naturally occurring nonenzymatic series of reactionsbetween sugars and proteins. This results in a productthat exceeds the clinical performance of previous colla-gen-based devices and includes advantages such aslongevity, low immunogenicity, easy injectability, natu-ral-appearing results, and lower rates of postinjectionswelling and bruising.8 In a phase III study, direct com-parison of Dermicol-P35 and Restylane (MedicisAesthetics, Scottsdale, AZ) in a split-face design showedthat both products were equally effective in reducingnasolabial folds, with fewer adverse events being report-ed for Dermicol-P35.9 This article focuses on the theauthor’s clinical experience with patients who under-went rhinoplasty augmentation procedures usingDermicol-P35.

METHODSA total of 12 patients were enrolled in this study. The num-ber of sessions was not limited in advance but was deter-mined retrospectively by patient satisfaction. In case of anuneven correction, the filler was manually molded immedi-ately after injection.

Dermicol-P35 30G (Evolence Breeze) was used in mostpatients until the spring of 2008, when the consistency ofDermicol-P35 27G (Evolence) was improved, therebyavoiding the occurrence of needle clogging. This improvedconsistency allowed Evolence Classic to be used for deli-cate procedures, such as rhinoplasty augmentation. Theprimary difference between the 2 products is the shortercollagen fiber length in Dermicol-P35 30G, which allows itto be delivered through a 30-gauge needle instead of a 27-gauge needle. Only topical anesthesia was used (10% lido-caine cream). Satisfaction was recorded on a scale of 1 to 5.

A growing number of patients with congenital or acquired nasal defects is seeking nonsurgical procedures to correctthe appearance of their nose. The use of fillers for the correction of nasal deformities is expanding because of their lowrisk and reversibility compared with surgery. Dermicol-P35 (Evolence; Ortho Dermatologics, Skillman, NJ) is a novelcrosslinked, fibrillar type I collagen isolated from porcine tendons that has not been associated with the same degreeof immunogenicity as bovine collagen. The use of Dermicol-P35 in this study of 12 subjects was associated with hightolerance, as well as a high degree of satisfaction. (Aesthetic Surg J 2009;29:S22–S24.(( )

From the Department of Plastic Surgery, University of Catania,Catania, Italy.

The Use of Dermicol-P35 Dermal Fillerfor Nonsurgical RhinoplastyDaniel Cassuto, MD

S22-S24_YMAJ656_Cassuto_CP:Layout 1 6/24/09 3:17 PM Page S222222S222222222S222

Volume 29 • Number 3S • May/June 2009 • S23The Use of Evolence Dermal Filler for Nonsurgical Rhinoplasty

RESULTSThe demographic information of the 12 patients, whowere between 23 and 63 years of age (mean 43 years), issummarized in the Table. The majority of the patientswere women (4:1). Skin types were Fitzpatrick 2 and 3.Trauma was the main reason for patients in the study toopt for a rhinoplasty augmentation procedure; the otherremaining reasons were rhinoplasty and basal cell carci-noma excision surgery. Although surgery was indicatedin 2 rhinoplasty cases, these patients, who had alreadyundergone a secondary rhinoplasty, were reluctant tohave surgery a third time. The 3 patients who hadundergone basal cell carcinoma excision surgery opted

for a soft tissue defect correction via injection, becausethey preferred cosmetic improvement without any addi-tional surgery.

All patients tolerated the injections without experi-encing any adverse events. The average amount ofDermicol-P35 27G or 30G injected was 0.6 mL. Most cor-rections (67%) were accomplished in 1 session, whilethe rest required a touch-up after 1 month. The meanfollow-up was 8 months, during which the correctionwas stable. The average satisfaction score was 4.6 out of5. These data are summarized in the Table. Photographicevidence of a patient before and after treatment is givenin the Figure.

Table. Demographics and results by patient

Dermicol-Patient Fitzpatrick Injected Follow-up, No. of Satisfaction P35 no. Age (y) skin type Sex Etiology volume, mL months sessions on scale 1 to 5 AEs type

1 44 2 F Trauma 0.6 8 1 5 — 30 G

2 23 3 F Rhinoplasty 0.8 16 2 4 — 30 G

3 49 2 F Trauma 0.5 14 2 5 — 30 G

4 46 2 F BCC 0.6 12 2 4 — 30 G

5 53 3 F BCC 0.5 2 1 5 — 27 G

6 31 3 M Trauma 0.4 8 1 4 — 30 G

7 57 3 M Rhinoplasty 0.5 15 1 5 — 30 G

8 63 3 F BCC 1.0 7 2 5 — 30 G

9 42 3 F Trauma 0.6 2 1 5 — 27 G

10 29 3 F Trauma 0.4 5 1 4 — 27 G

11 51 3 M Trauma 0.6 9 1 5 — 30 G

12 32 3 F Trauma 0.7 8 1 4 — 30 G

Mean 43 — 1:4 (M:F) — 0.6 8 1.3 4.6 — —

AE, Adverse event; BCC, basal cell carcinoma; F, female; M, male. Dermicol-P35 is manufactured by Ortho Dermatologics (Skillman, NJ).

A B

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.

C

S22-S24_YMAJ656_Cassuto_CP:Layout 1 6/24/09 3:17 PM Page S23


DISCUSSIONDermicol-P35 is composed of collagen fibers that fix tothe tissue and do not migrate from the location of injec-tion. It also has a color that resembles that of the naturaldermis. As such, Dermicol-P35 can be used in locationswhere the skin is very thin, such as the top of the nose,without appearing as a blemish. This advantage is obvi-ously very important in the field of cosmetic medicine.The product also acts as a scaffold to the surroundingtissues, promoting neovascularization and new endo-genic collagen formation.10

As previously mentioned, the use of HA-based fillersis limited by the bruising and swelling that occur afterinjection. The use of earlier collagens was limitedbecause of their high immunogenicity, the need for apretreatment skin test, and their lack of longevity. Theseshortcomings are mostly resolved by the introduction ofDermicol-P35. Because of the sugar-based inter- andintramolecular crosslinking of collagen fibers inDermicol-P35, the product is highly persistent andhypersensitivity is minimal.7,11

The lack of reactivity with porcine collagen was par-ticularly reassuring in patients after tumor excision.10

Furthermore, it helped to keep local tissues available foreventual reconstruction with flaps in case of a recur-rence. Particular care was taken when performing injec-tions in patients with secondary and tertiary rhinoplasty,so that flaps with limited perfusion were not separatedfrom their vascular bed by the filler. A histologic studyhas shown that Dermicol-P35 27G was surrounded by athin capsule after 2 to 3 months.10 Macroscopically, 3months after injection, the implant looks like a firm, drycottage cheese, which makes it easy to identify, dissect,and remove during future surgery, if necessary.

CONCLUSIONThe use of Dermicol-P35 for rhinoplasty augmentation isassociated with a high degree of clinician and subject sat-isfaction in this small set of patients. The properties of thisfiller render it suitable for the safe correction of some nasaltissue defects without jeopardizing surgical options for thefuture. More extensive studies would be needed to confirmthese results. ◗

ACKNOWLEDGMENT

Editorial support was provided by Keni CS Lee, PhD, and MukundNori, PhD, MBA, Envision Pharma (Southport, CT).

DISCLOSURES

The author has no financial interest in products mentioned in thisarticle.

REFERENCES 1. Constantinidis J, Daniilidis J. Aesthetic and functional rhinoplasty.

Hosp Med 2005;66:221–226.2. Bracaglia R, Fortunato R, Gentileschi S. Secondary rhinoplasty.

Aesthetic Plast Surg 2005;29:230–239.

3. Han SK, Shin SH, Kang HJ, Kim WK. Augmentation rhinoplasty usinginjectable tissue-engineered soft tissue: A pilot study. Ann Plast Surg2006;56:251–255.

4. Carruthers JD, Glogau RG, Blitzer A, Facial Aesthetics ConsensusGroup Faculty. Advances in facial rejuvenation: Botulinum toxin typeA, hyaluronic acid dermal fillers, and combination therapies–consensusrecommendations. Plast Reconstr Surg 2008;121(5 Suppl):5S–30S.

5. Redaelli A. Medical rhinoplasty with hyaluronic acid and botulinumtoxin A: A very simple and quite effective technique. J CosmetDermatol 2008;7:210–220.

6. Beer KR. Nasal reconstruction using 20 mg/mL cross-linked hyaluronicacid. J Drugs Dermatol 2006;5:465–466.



9. Narins RS, Brandt FS, Lorenc ZP, et al. A randomized, multicenterstudy of the safety and efficacy of Dermicol-P35 and non-animal-stabi-lized 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-termefficacy of a novel ribose-cross-linked collagen dermal filler: A histolog-ic and histomorphometric study in an animal model. Dermatol Surg2007;33:1045–1054.



Reprint requests: Daniel Cassuto, MD, Department of Plastic Surgery,University of Catania, Piazza Cinque Giornate 1, 20129 Milan, Italy. E-mail:[email protected].


1090-820X/$36.00

doi:10.1016/j.asj.2009.03.003

S22-S24_YMAJ656_Cassuto_CP:Layout 1 6/24/09 3:17 PM Page S242224S222222242S222



Although a universal definition describing an idealpair of lips does not exist, a pair of proportionallyprojecting feminine lips is generally considered to

be sexually attractive.1 As one ages, the lips areinevitably subjected to predictable physical changes thatoften prompt women to seek lip augmentation and/orrejuvenation in an attempt to improve their appearance.Lip augmentation can be loosely defined as a procedureto enhance the fullness of lips. Lip rejuvenation refers toa procedure for the correction of lip lines, restoration ofthe contour and buttresses, and redirection of the droop-ing angles of the lips, all with the aim of reversing thechanges associated with aging.

In recent years, an increasing number of interventionshave been introduced that seek to improve the appear-ance of the lips. These include tissue or autologous fatgrafts, alloplastic implants, and surgical procedures onlip mucosa. The use of injectable fillers is the most com-mon technique for lip shape and volume enhancement.Two of the more popular injectable fillers are made fromhyaluronic acid (HA) or collagen, both of which are nat-ural constituents of the normal dermis.2

Collagen was one of the first fillers for aestheticenhancement and has been in use for more than 20 years.The results of lip shaping by collagen have always beenhighly appreciated aesthetically. However, because of therelatively short longevity of the results, the earlyinjectable collagen devices have been replaced by HA-based fillers for this indication. In its pure form, HA is anaturally occurring linear polysaccharide with a low riskof immunogenicity because of its lack of species or tissuespecificity. Studies on nonanimal, stabilized HA devices

such as Restylane (Medicis Pharmaceutical Corp.,Scottsdale, AZ) have shown favorable efficacy results anda low incidence of adverse events following injection.3,4

However, HA fillers are hygroscopic and these procedureson the lips are inevitably accompanied by bruising andswelling. More recent studies have also raised concernsover delayed adverse events relating to HA.5,6

Dermicol-P35 (Evolence; Ortho Dermatologics,Skillman, NJ) is a suspension of crosslinked, fibrillartype I collagen isolated from porcine tendons. Dermicol-P35 is considered more “human-like” and has not beenassociated with the same degree of immunogenicity asbovine collagen.7 The inter- and intramolecular cross-linking of collagen fibers in Dermicol-P35 fillers is pro-duced via D-ribose glycation, a naturally occurringnonenzymatic series of reactions between sugars andproteins.

This results in a product that exceeds the clinical per-formance of previous collagen-based devices andincludes advantages such as longevity, low immuno-genicity, easy injectability, natural-appearing results, anda lower rate of postinjection swelling and bruising.8

Dermicol-P35 30G is a newer formulation containingshorter collagen fibers that allow the product to flowthrough a smaller needle lumen. The major practical dif-ference between the 2 products is that Dermicol-P35 27Gis delivered through a 27-gauge needle, while Dermicol-P35 30G is delivered through a 30-gauge needle. Thisarticle focuses on the author’s clinical experience withpatients who underwent lip augmentation and rejuvena-tion procedures using Dermicol-P35 30G.

PATIENTS AND PROCEDURESLip augmentation and rejuvenation procedures usingDermicol-P35 30G were performed on 15 patients

Predictable changes in the lips caused by aging often prompt women to seek lip augmentation and/or rejuve-nation. This article describes the clinical experience of patients who underwent lip augmentation and rejuve-nation procedures using Dermicol-P35 30G (Evolence Breeze; Ortho Dermatologics, Skillman, NJ) a novel, D-ribose cross-linked, porcine collagen dermal filler. The majority of patients reported that the improvementafforded by Dermicol-P35 30G was either good or very good 3 months after their procedure, with minimaladverse effects. (Aesthetic Surg J 2009;29:S12–S15.(( )

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

Lip Augmentation and RejuvenationUsing Dermicol-P35 30G: PersonalExperiences From My ClinicMarina Landau, MD



(Table). The use of any anticoagulant or antiplateletmedication was prohibited before the procedures. Oralacyclovir (400 mg twice daily for 5 days) was adminis-tered to those with a previous history of herpes labialis.A thorough assessment of lip shape, volume, and condi-tion was performed before Dermicol-P35 30G injection.

The initial stages of the procedures on lips wereperformed under local anesthesia because the lips areone of the most sensitive areas of the face. Dermicol-P35 30G was mixed with a local anesthetic (0.3 mLlidocaine 1%) to render the injections more tolerableto patients. The mixture was performed through acommercially available female-to-female connectorunder strict aseptic conditions.

The results were assessed immediately after the pro-cedure, after 2 to 3 weeks, and after 3 months. Adverseevents were assessed by the physician up to 6 monthsafter the procedure.

RESULTSAs we have previously reported, 15 patients were includedin the study.9 All of the patients were women, with a meanage of 52.3 years (range 42-61 years). Nine patients under-went lip rejuvenation (with or without correction of thenasolabial folds) and 6 patients underwent lip augmenta-tion (with or without correction of the nasolabial folds;Table). The mean amount of Dermicol-P35 30G used perpatient was 1.4 mL (range 1.0-2.2 mL).

Three months after the procedures, 13 patients(86.7%) reported that the improvement afforded byDermicol-P35 30G was either good or very good and 2patients (13.3%) reported that the improvement was sat-isfactory. Only 3 patients who initially received a mini-

mal amount of filler (1 mL) required a touch-up 2 weeksafter the procedure.

The addition of 0.3 mL lidocaine 1% did not affect thelongevity or the efficacy of Dermicol-P35 30G. Contraryto cases where topical or regional pretreatment anesthe-sia was used, no distortion of the lip shape and volumeoccurred. Because swelling was minimal during the injec-tion, the final result was more visible and could be moreeasily appreciated by the physician and the patient.

In contrast to our previous experience with HA-baseddermal fillers, only minimal swelling on the lips was not-ed after injection with Dermicol-P35 30G. Transientlumps on the lips were reported, but spontaneouslycleared within 4 weeks after the procedure.

PatientsPatient 1. A 47-year-old woman (Figure 1) was

injected with 1.2 mL of Dermicol-P35 30G into the lowerand upper lips in order to enhance their volume and tocorrect the slight asymmetry in the shape of the rightpart of the lower lip. Immediate results were obtained,where more symmetric and pleasantly plump lips wereobserved. No swelling or bruising was noted.

Patient 2. A 42-year-old woman presented with anunsatisfactory appearance in the shape of her lips,mainly because of the upper lip, which lacked volume.Lip augmentation to correct the volume and redefinethe vermillion border of the lip was performed with1.0 mL of Dermicol-P35 30G. A comparison made onphotographs taken before and after the procedure(Figure 2) shows that the philtral columns were suc-cessfully reconstructed, which makes the upper liplook pleasantly shorter.

Table. Patient demographics and satisfaction after procedure

Patient satisfaction Touch-up Amount of Nasolabial Patient no. at 3 months in 2 weeks filler, mL correction Indication Age, y Sex







7 Good – 2.0 + Rejuvenation 59 F


9 Satisfactory + 1.0 + Augmentation 44 F





14 Satisfactory – 1.2 – Augmentation 47 F


F, Female.FF



Patient 3. A 57-year-old patient with upper lip wrin-kles and blurred vermilion border of both lips wasinjected with 1.0 mL of Dermicol-P35 30G. Threemonths after the procedure, an almost absolute disap-pearance of the wrinkles was noted. The postprocedurephotograph clearly shows that a redefinition of the ver-milion border rejuvenated the patient’s appearance.

DISCUSSIONInjectable fillers for dermal contour corrections originatedwith the introduction of Zyderm and Zyplast (McGhanMedical Corp., Fremont, CA)10 injectable bovine collagenin the United States in 1981.9 These agents opened up thepossibilities for lip augmentation and rejuvenation to cre-ate a fuller appearance. Since the mid-1990s, HA-basedfillers have provided an additional option to the physi-cian. As mentioned above, the continuing use of HA-based fillers, especially on the lips, is limited by thebruising and swelling that occur after injection.

The ideal injectable filler for immediate correction ischaracterized by a long-term persistency and a lowoccurrence of adverse events or complications.11 The useof bovine injectable collagens was limited because of thehigh incidence of allergies and the need for a pretreat-ment skin test, as well as their limited duration of clinicalcontour correction. Although human-sourced collagenssuch as CosmoDerm and CosmoPlast (Allergan, SantaBarbara, CA) may circumvent the need for skin tests, theuse of glutaraldehyde-based crosslinking technology lim-its the extent of crosslinking that can be achieved and thenature of the crosslinks formed.11,12

The deficiencies of earlier collagen-based fillers aremostly resolved by the introduction of Dermicol-P35filler. The inter- and intramolecular cross-linking of col-lagen fibers in Dermicol-P35 filler are generated via gly-cation, which results in a product that is resistant tolocal enzymatic degradation.12 In addition, a pretreat-ment skin test is unnecessary and the occurrence of

A B

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 Dermicol-P35 30G into the lower and upper lips.

A B

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 30Ginto the upper lip.



A B

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-P3530G into both lips.

hypersensitivity is minimal.13 The sugar-based cross-linkers used to produce Dermicol-P35 also result in astructure with enhanced integrity and strength, whichcould lead to higher persistency in areas that are subject-ed to corrections.

Based on the experience garnered during this study,Dermicol-P35 30G was found to be especially efficient inthe treatment of small upper lip wrinkles (Figure 3). Ourexperience has shown that these wrinkles are extremelychallenging and cannot be efficiently eliminated usingHA-based fillers without some swelling of the upper lipskin or linear ridges along the injection lines. On thecontrary, the use of Dermicol-P35 30G in the lip regionproduced relatively minimal swelling and bruising. Thisrendered the procedure more acceptable and the imme-diate results could be more easily appreciated. Thelongevity of the results in the lips was another importantadvantage of this filler.

The advantages of Dermicol-P35 when compared withprevious collagen-based fillers were successfully shown inclinical trials.8 The satisfaction expressed by the majorityof patients in this study further supported the remarkableeffectiveness and safety of Dermicol-P35 30G when usedin lip augmentation and rejuvenation procedures.

CONCLUSIONSThe use of Dermicol-P35 30G for lip augmentation andrejuvenation is associated with a high degree of clinicianand subject satisfaction. There were minimal and mostlymild adverse events that resolved quickly. ◗

ACKNOWLEDGMENT

Editorial support was provided by Keni CS Lee, PhD, and MukundNori, PhD, MBA, of Envision Pharma, Southport, CT.

DISCLOSURES

The author speaks for Johnson & Johnson occasionally duringCongresses, presenting her own clinical experience with their product.

REFERENCES1. Sutter RE Jr, Turley PK. Soft tissue evaluation of contemporary

Caucasian and African American female facial profiles. Angle Orthod1998;68:487–496.

2. Carruthers JD, Glogau RG, Blitzer A, Facial Aesthetics ConsensusGroup Faculty. Advances in facial rejuvenation: Botulinum toxin typeA, hyaluronic acid dermal fillers, and combination therapies—consen-sus recommendations. Plast Reconstr Surg 2008;121(5 Suppl):5S–30S.

3. Olenius M. The first clinical study using a new biodegradable implantfor the treatment of lips, wrinkles, and folds. Aesthetic Plast Surg1998;22:97–101.

4. Duranti F, Salti G, Bovani B, Calandra M, Rosati ML. Injectablehyaluronic acid gel for soft tissue augmentation. A clinical and histo-logical study. Dermatol Surg 1998;24:1317–1325.

5. Lowe NJ, Maxwell CA, Lowe P, Duick MG, Shah K. Hyaluronic acidskin fillers: Adverse reactions and skin testing. J Am Acad Dermatol2001;45:930–933.

6. Lupton JR, Alster TS. Cutaneous hypersensitivity reaction to injectablehyaluronic acid gel. Dermatol Surg 2000;26:135–137.

7. Nir E, Goldlust A, Shoshani D, Azachi M. Long-term in vivo evaluationof the safety and efficacy of a new porcine collagen dermal filler cross-linked with ribose [abstract]. J Am Acad Dermatol 2008;58:AB63.



10. Klein AW. Indications and implantation techniques for the various for-mulations of injectable collagen. J Dermatol Surg Oncol 1988;14(Suppl 1):27–30.



13. Shoshani D, Markovitz E, Cohen Y, Heremans A, Goldlust A. Skin testhypersensitivity study of a cross-linked, porcine collagen implant foraesthetic surgery. Dermatol Surg 2007;33(Suppl 2):S152–S158.

Accepted for publication January 23, 2009.

Reprint requests: Marina Landau, MD, Joshua Ben Nun St., 56 HerzliyaPituach, Israel 46763. E-mail: [email protected].


1090-820X/$36.00

doi:10.1016/j.asj.2009.02.010



Volume 29 • Number 3S • May/June 2009 • S25Dermicol-P35: Techniques in Facial and Hand Rejuvenation

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-linkingb. increased collagen depositionc. chronologic and environmental processesd. lack of physical activity

2. The 2 most commonly used components of dermalfillers are _________.a. collagen and fatb. collagen and hyaluronic acidc. silicone and fatd. silicone and collagen

3. Dermicol-P35 differs from other collagens in that it________.a. does not require a skin test prior to useb. is of human originc. is hydrophylicd. uses glutaraldehyde for cross-linking

4. In patients with acne scars, collagen-based dermalfillers are not successful in treating _______.a. shallow boxcar scars b. pitted scarsc. deep boxcar scarsd. ice-pick scars

5. A Tyndall effect can be observed when ________.a. autologous fat is injected into the lipsb. collagen-based fillers are injected into thin skin

areas, eg, under the eyesc. hyaluronic acid-based fillers are injected into

thin skin areas, eg, under the eyesd. 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 flowb. reduced dorsal vein and tendon prominencec. increased ventral hand soft tissued. reduced carpal tunnel syndrome

7. The effects of augmenting the lips with Dermicol-P35 produces results that are ____________.a. swollenb. redc. firmd. visible immediately

8. In rhinoplasty, Dermicol-P35 acts as a __________.a. structural elementb. gluec. bridged. hemostatic agent

9. Injection techniques for cheek augmentation withDermicol-P35 include __________.a. microdropletsb. depot techniquec. crosshatching with linear threadingd. pooling

10. Unlike hyaluronic acid-based fillers, Dermicol-P35_________.a. is hydrophilicb. is a by-product of bacterial fermentationc. may be reversed with an enzymed. is a suspension of cross-linked fibers

S25_YMAJ667_Test_CP:Layout 1 6/24/09 3:17 PM Page S25

S26 • Volume 29 • Number 3S1 • May/June 2009 Aesthetic Surgery Journal

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 printyour 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 EducationDepartment YMAJ 293S

60B Columbia RoadMorristown, 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. a b c d 4. a b c d 7. a b c d2. a b c d 5. a b c d 8. a b c d3. a b c d 6. a b c d 9. a b c d

10. a b c dRelease Date of Activity: July 1, 2009Expiration Date of Activity for AMA PRA credit: July 30, 2010Estimated Time to Complete this Activity: 2.5 Hours

CME CertificatesTo get instant CME credits online, log on to www.elseviercme.com/getcme/YMAJ293S. Upon successful completionof the online evaluation form, you can instantly download and print your certificate of credit. Please add [email protected] to your email ‘safe’ list.

Name____________________________ Specialty___________________________

Degree : ❏ MD ❏ DO ❏ PharmD ❏ RPh NP ❏ RN ❏ BS ❏ PA ❏ Other_________

Affiliation____________________________________________________________

Address______________________________________________________________

City___________________________ State_______ ZIP_______________

Telephone______________________ Fax___________________________

E-mail Address__________________ Signature_______________________

CME Credit VerificationI verify that I have spent ____ hours/____ minutes of actual time working on this CME activity. (No more than 2.5CME credits will be issued for this activity.)

http://www.elseviercme.com/getcme/YMAJ293S

http://www.elseviercme.com/getcme/YMAJ293S



Volume 29 • Number 3S1 • May/June 2009 • S27Dermicol-P35: Techniques in Facial and Hand Rejuvenation

CME EVALUATION FORM

Please evaluate the effectiveness of this activity in helping you to do each of the following by circling your choice on ascale of 1 to 5, with 1 the lowest and 5 the highest.

1. Discuss the role of dermal fillers in aesthetic and corrective procedures 1 2 3 4 5

2. Describe the differences between collagen-based and hyaluronic acid-based dermal fillers 1 2 3 4 5

3. Determine the issues influencing the choice of dermal filler 1 2 3 4 5

4. Identify and describe the technical challenges of injecting dermal fillers in different partsof the face and hands 1 2 3 4 5

5. Recognized the key characteristics of Dermicol-P35 1 2 3 4 5

6. How do you rate the overall quality of the activity? 1 2 3 4 5

7. How do you rate the educational content of the activity? 1 2 3 4 5

Was the information presented to be fair, objective, balanced, and free of bias in the discussion of any commercialproduct 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 CMEactivities? ____Yes ____No

The EOCME thanks you for participation in this CME activity. All information provided improves the scope and pur-pose of our programs and your patients’ care.

S27_YMAJ670_Course_CP:Layout 1 6/24/09 3:17 PM Page S27

dermicol-p35 collagen - techniques in facial and hand rejuvenation (2009)

Documents