Background: This is a report of the secondary endpoints, Subject Global Evaluation (overall improvement) and Subject Satisfaction scores, from a study designed to examine the efficacy of injectable poly-l-lactic acid for the correction of nasolabial fold wrinkles over 25 months.
Methods: A randomized, subject-blinded, parallel-group, multicenter clinical study was conducted to compare the effects of injectable poly-l-lactic acid with those of human collagen for the treatment of nasolabial fold wrinkles at 13 months following the last treatment. Injectable poly-l-lactic acid–treated subjects were followed for 25 months.
Results: From month 3 through month 13 following the last treatment, injectable poly-l-lactic acid–treated subjects (n = 116) reported significantly higher Subject Global Evaluation scores compared with human collagen–treated subjects (n = 117; p < 0.001). Overall Subject Global Evaluation scores for injectable poly-l-lactic acid–treated subjects were 99 percent at week 3, 91 percent at month 13, and 81 percent at month 25 (all times following the last treatment). In contrast, for human collagen–treated subjects, overall Subject Global Evaluation scores declined by 84 percent, from 96 percent at week 3 to 15 percent at month 13. Subject Satisfaction scores were significantly different (p < 0.01) between treatment groups beginning week 3 and continuing through month 13. Overall Subject Satisfaction scores were maintained for over 80 percent of injectable poly-l-lactic acid–treated subjects (n = 106) at month 25 after the last treatment.
Conclusions: Treatment of nasolabial fold wrinkles with injectable poly-l-lactic acid resulted in statistically significantly higher Subject Global Evaluation and Subject Satisfaction scores compared with human collagen at 13 months. Injectable poly-l-lactic acid–treated subjects maintained improvements for up to 25 months after treatment.
Dallas, Texas; Miami, Coral Gables, and Boca Raton, Fla.; Buffalo Grove, Ill.; Los Angeles and Santa Monica, Calif.; Birmingham, Ala.; New York and White Plains, N.Y.; and Seattle and Spokane, Wash.
From the University of Texas Southwestern Medical Center; University of Miami; private practice; University of California, Los Angeles School of Medicine; Clinical Research Specialists, Inc.; the Departments of Dermatology and Ophthalmology, University of Alabama at Birmingham; New York University School of Medicine; Dermatology and Aesthetic Center, Inc.; University of Washington School of Medicine; and Premier Clinical Research.
Received for publication June 22, 2010; accepted October 22, 2010.
Registration identification number: NCT00444210 (comparative study) and NCT00444353 (long-term follow-up). Clinical trial registry: http://clinicaltrials.gov.
Disclosure: The investigators of this study, sponsored by Dermik Laboratories, a business of Sanofi-Aventis U.S. LLC, have disclosed the following: Dr. Brown is a consultant for Wafergen Biosystems; Dr. Rohrich has no commercial or financial conflicts to report; Dr. Baumann was a consultant for Dermik Laboratories, a business of Sanofi-Aventis U.S. LLC, during the time of the study; Dr. Brandt, M.D., receives grant support from Dermik Laboratories and is an investigator for Medicis-Aesthetics and Allergan; Drs. Fagien and Glazer were consultants for Dermik Laboratories during the time of the study; Dr. Kenkel has no commercial or financial conflicts to report; Dr. Lowe was a consultant for and received grant support from Dermik Laboratories during the time of the study; Dr. Monheit was a consultant for Dermik Laboratories during the time of the study, is a consultant and clinical investigator for Allergan, Colbar LifeScience, Ltd., Electro-Optical Sciences, Inc., Galderma, Genzyme Corporation, Ipsen/Medicis, Mentor, Merz, and Revance, and is a consultant for Contura, Kythera, and Stiefel; Drs. Narins and Rendon were consultants for Dermik Laboratories during the time of the study. Dr. Rendon is also a consultant, advisory board member, and researcher for Galderma Laboratories, L.P., L'Oréal USA, La Roche-Posay Laboratoire Pharmaceutique, Sirrus Pharmaceutical Pharmacia, Unilever PLC, Johnson & Johnson, 3M, Medicis, SkinMedica, Inc., Janssen, L.P., Aveeno, The NeoStrata Company, Allergan, Inc., GlaxoSmithKline, Novartis Pharmaceuticals Corporation, and Merck & Co., Inc.; Dr. Werschler was a consultant, investigator, advisory board member, and speaker for Dermik Laboratories during the time of the study.
Spencer A. Brown, Ph.D., Department of Plastic Surgery, University of Texas Southwestern Medical Center, 1801 Inwood Road, 4th Floor, Dallas, Texas 75390-9132, firstname.lastname@example.org