A randomized study of the efficacy and safety of injectable poly-L-lactic acid versus human-based collagen implant in the treatment of nasolabial fold wrinkles

Background

Injectable poly-L-lactic acid (PLLA) is a synthetic, biodegradable, biocompatible polymer device.

Objective

We sought to compare the efficacy and safety of injectable PLLA with human-derived collagen in treating nasolabial fold wrinkles.

Methods

In this randomized, evaluator-blinded, parallel-group, multicenter study, subjects received injectable PLLA (n = 116) or collagen (n = 117) injections (1-4 visits, 3-week intervals). Wrinkle Assessment Scale scores were calculated at screening; posttreatment week 3; months 3, 6, 9, and 13 (injectable PLLA or collagen groups); and months 19 and 25 (injectable PLLA group). Safety data were obtained from subject interviews and case report forms.

Results

Injectable PLLA significantly improved mean Wrinkle Assessment Scale scores (all time points, P < .001). Improvements (up to 25 months after last treatment) were significantly greater (P < .001) than with collagen for posttreatment months 3 to 13.

Limitations

Mostly white women and subjects with Fitzpatrick skin types II and III were included.

Conclusion

Injectable PLLA provides well-tolerated, effective, and long-lasting (up to 25 months) nasolabial fold wrinkle correction.

Key words: aesthetic, dermal filler, injectable device, injectable poly-L-lactic acid, soft-tissue augmentation

Abbreviations used: AE, adverse event, CRF, case report form, NLFW, nasolabial fold wrinkles, PLLA, poly-L-lactic acid, WAS, Wrinkle Assessment Scale

a Department of Dermatology, New York University School of Medicine, New York, New York

b Division of Cosmetic Dermatology, University of Miami, Miami, Florida

c private practice, Coral Gables, Florida

d private practice, Boca Raton, Florida

e private practice, Buffalo Grove, Illinois

f Department of Dermatology, University of California-Los Angeles School of Medicine, Los Angeles, California

g Clinical Research Specialists, Inc, Santa Monica, California

h Departments of Dermatology and Ophthalmology, University of Alabama at Birmingham, Birmingham, Alabama

i Dermatology and Aesthetic Center, Inc, Boca Raton, Florida

j University of Texas Southwestern Medical Center, Dallas, Texas

k Medicine/Dermatology, University of Washington School of Medicine, Seattle, Washington

l Premier Clinical Research, Spokane, Washington

Reprint requests: Rhoda S. Narins, MD, Dermatology Surgery and Laser Center, 222 Westchester Ave, White Plains, NY 10604.

Sponsored by Dermik Laboratories, a business of sanofi-aventis U.S. LLC. Editorial support for this article was also provided by Dermik Laboratories, a business of sanofi-aventis U.S. LLC, and by the editorial staff at Medicus International and Embryon.

Disclosure: Drs Narins, Baumann, Fagien, Glazer, and Monheit were consultants for Dermik Laboratories, a business of sanofi-aventis U.S. LLC, during the time of the study. Dr Brandt receives grant support from Dermik Laboratories, a business of sanofi-aventis U.S. LLC. Dr Lowe was a consultant for and received grant support from Dermik Laboratories, a business of sanofi-aventis U.S. LLC, during the time of the study. Dr Rendon is a consultant for and receives grant support from Dermik Laboratories, a business of sanofi-aventis U.S. LLC. In addition, Dr Rendon is an advisory board member for and receives grant support from BioForm Medical Inc. Dr Werschler was a consultant, investigator, advisory board member, and speaker for Dermik Laboratories, a business of sanofi-aventis U.S. LLC, during the time of the study. Dr Rohrich has no conflicts of interest to declare.

Clinical trial registry: NCT00444210 (comparative study); NCT00444353 (long-term follow-up).

PII: S0190-9622(09)00962-1

doi:10.1016/j.jaad.2009.07.040

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