title: Investigator global evaluations of efficacy of injectable poly-L-lactic acid versus human collagen in the correction of nasolabial fold wrinkles.
abstract: BACKGROUND
  Injectable poly-L-lactic acid (PLLA) is indicated in the United States for use in immune-competent patients for correction of shallow-to-deep nasolabial fold contour deficiencies and other facial wrinkles in which a deep dermal grid pattern injection technique is appropriate. It is also indicated for restoration and/or correction of signs of lipoatrophy in patients with human immunodeficiency virus.
  
  
  OBJECTIVE
  The authors examine the efficacy of injectable PLLA for correction of nasolabial fold wrinkles, based on Investigator Global Evaluations (IGE).
  
  
  METHODS
  A randomized, multicenter, subject-blinded, parallel-group study compared injectable PLLA versus human collagen for correction of nasolabial fold wrinkles for 13 months after up to four treatments (intent-to-treat population, 233). Injectable PLLA-treated subjects were followed up for an additional 12 months (total, 25 months) after the final treatment session. Efficacy was also assessed through secondary IGE for improvement, which is the subject of this report.
  
  
  RESULTS
  IGE reports of improvement were significantly greater in subjects who received injectable PLLA versus those who received human collagen (p < .001). Overall improvement with injectable PLLA was 100% three weeks after the final treatment, remaining above 85% through month 25. Overall IGE of improvement with human collagen declined from 94.0% at week three to 6.0% at month 13. Both treatment groups had similar safety profiles.
  
  
  CONCLUSIONS
  IGE of improvement were significantly greater with injectable PLLA treatment than with human collagen treatment at all time points following the last treatment. Injectable PLLA treatment continued to show a beneficial effect for up to 25 months.
authors: University of Miami, Miami, Florida, USA.
authors: Fredric S
authors: FS
authors: Brandt
authors: Alex
authors: A
authors: Cazzaniga
authors: Leslie
authors: L
authors: Baumann
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: Rod J
authors: RJ
authors: Rohrich
authors: William Philip
authors: WP
authors: Werschler
mesh_terms: D000328:Adult; D001672:Biocompatible Materials / Q000008:administration & dosage; D003094:Collagen / Q000008:administration & dosage*; D003357:Cosmetic Techniques; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007267:Injections; D019344:Lactic Acid / Q000008:administration & dosage*; D011091:Polyesters; D011108:Polymers / Q000008:administration & dosage*; D016037:Single-Blind Method; D015595:Skin Aging; D016896:Treatment Outcome
chemical_list: D001672:Biocompatible Materials; D011091:Polyesters; D011108:Polymers; D019344:Lactic Acid; C033616:poly(lactide); D003094:Collagen