title: Subject global evaluation and subject satisfaction using injectable poly-L-lactic acid versus human collagen for the correction of nasolabial fold wrinkles.
abstract: 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.
authors: 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.
authors: Spencer A
authors: SA
authors: Brown
authors: Rod J
authors: RJ
authors: Rohrich
authors: Leslie
authors: L
authors: Baumann
authors: Fredric S
authors: FS
authors: Brandt
authors: Steven
authors: S
authors: Fagien
authors: Scott
authors: S
authors: Glazer
authors: Jeffrey M
authors: JM
authors: Kenkel
authors: Nicholas J
authors: NJ
authors: Lowe
authors: Gary D
authors: GD
authors: Monheit
authors: Rhoda S
authors: RS
authors: Narins
authors: Marta I
authors: MI
authors: Rendon
authors: William Philip
authors: WP
authors: Werschler
mesh_terms: D001672:Biocompatible Materials / Q000008:administration & dosage*; D003094:Collagen / Q000008:administration & dosage*; D003357:Cosmetic Techniques; D005260:Female; D006801:Humans; D007267:Injections; D019344:Lactic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D017060:Patient Satisfaction; D011091:Polyesters; D011108:Polymers / Q000008:administration & dosage* / Q000009:adverse effects; D015595:Skin Aging
chemical_list: D001672:Biocompatible Materials; D011091:Polyesters; D011108:Polymers; D019344:Lactic Acid; C033616:poly(lactide); D003094:Collagen