COSMETIC Subject Global Evaluation and Subject Satisfaction Using Injectable Poly-L-Lactic Acid versus Human Collagen for the Correction of Nasolabial Fold Wrinkles Spencer A. Brown, Ph.D. Rod J. Rohrich, M.D. Leslie Baumann, M.D. Fredric S. Brandt, M.D. Steven Fagien, M.D. Scott Glazer, M.D. Jeffrey M. Kenkel, M.D. Nicholas J. Lowe, M.D. Gary D. Monheit, M.D. Rhoda S. Narins, M.D. Marta I. Rendon, M.D. William Philip Werschler, M.D. 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. Background: This is a report of the secondary endpoints, Subject Global Eval- uation (overall improvement) and Subject Satisfaction scores, from a study designed to examine the efficacy of injectable poly-L-lactic acid for the correc- tion 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, inject- able poly-L-lactic acid–treated subjects (n = 116) reported significantly higher Subject Global Evaluation scores compared with human collagen–treated sub- jects (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. In- jectable poly-L-lactic acid–treated subjects maintained improvements for up to 25 months after treatment. (Plast. Reconstr. Surg. 127: 1684, 2011.) S atisfaction with treatment is important in de- termining the overall success of aesthetic procedures. 1,2 For the patient, it is tied to improvements in quality of life, psychological well- being, and personal satisfaction. 2 It is noteworthy that physicians and patients evaluate the outcome of soft-tissue augmentation treatment differently: physicians tend to focus on technical aspects of treatment delivery (e.g., injection technique) and the overall incidence of adverse events, whereas patients focus on whether the treat- ment met their expected outcomes. 3,4 There- fore, it is important to include evaluation of patient satisfaction with treatment as a measure of efficacy in the assessment of new treatments for soft-tissue augmentation. Injectable poly-L-lactic acid (Sculptra Aes- thetic and Sculptra; Dermik Laboratories, a busi- ness of Sanofi-Aventis U.S. LLC, Bridgewater, N.J.) is a synthetic, biodegradable, biocompatible, poly- meric device. 5 It is approved in the United States for use in immunocompetent people as a single 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, Uni- versity 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 (com- parative study) and NCT00444353 (long-term follow-up). Clinical trial registry: http://clinicaltrials.gov. Copyright ©2011 by the American Society of Plastic Surgeons DOI: 10.1097/PRS.0b013e318208d371 www.PRSJournal.com 1684