title: Efficacy of incobotulinumtoxinA for treatment of glabellar frown lines: a post hoc pooled analysis of 2 randomized, placebo-controlled, phase 3 trials.
abstract: BACKGROUND
  Botulinum neurotoxin type A trials in aesthetic indications have used differing efficacy parameters and responder definitions.
  
  
  OBJECTIVE
  To analyze the treatment efficacy and duration of incobotulinumtoxinA for glabellar frown lines using pooled data from 2 large, Phase 3, placebo-controlled trials, and end points similar to those used in previous botulinum neurotoxin type A studies.
  
  
  METHODS
  IncobotulinumtoxinA and placebo groups comprised 366 and 181 subjects, respectively. The efficacy of a single 20-U treatment of incobotulinumtoxinA or placebo was evaluated by investigator-assessed and subject-assessed responder rates (≥ 1-point improvement from baseline), mean score, and mean change from the baseline glabellar frown line severity score.
  
  
  RESULTS
  At all follow-up visits, responder rates and mean change from the baseline score (investigator-assessed and subject-assessed) were significantly greater for incobotulinumtoxinA versus placebo (p < .0001). The maximum investigator-assessed responder rate (93.1%) was achieved at Day 30 after treatment, when the mean improvement on the 4-point facial wrinkle scale peaked at 1.88. Treatment effect declined over time but the investigator-assessed responder rate was 45.7% at the end of the study.
  
  
  CONCLUSIONS
  Superiority of incobotulinumtoxinA over placebo for treating glabellar frown lines was confirmed. IncobotulinumtoxinA achieved a maximum responder rate of 93.1% and a long duration of treatment effect: 45.7% of subjects showed efficacy at 120 days.
authors.affiliation: *Skin Care and Laser Physicians of Beverly Hills, Los Angeles, California; †Carruthers Clinical Research, Vancouver, BC, Canada; ‡Dermatology Surgery and Laser Center, White Plains, New York; §Coleman Cosmetic Dermatologic Surgery Center, Metairie, Louisiana; ‖Ogilvy 4D, Oxford, United Kingdom; ¶Dermatology Research Institute, Coral Gables, Florida; #AboutSkin Dermatology and DermSurgery, Englewood, Colorado.
authors.forename: Derek
authors.initials: D
authors.lastname: Jones
authors.forename: Jean
authors.initials: J
authors.lastname: Carruthers
authors.forename: Rhoda S
authors.initials: RS
authors.lastname: Narins
authors.forename: William P
authors.initials: WP
authors.lastname: Coleman
authors.forename: Laura
authors.initials: L
authors.lastname: Harrington
authors.forename: Fredric S
authors.initials: FS
authors.lastname: Brandt
authors.forename: Joel L
authors.initials: JL
authors.lastname: Cohen
mesh_terms: D000328:Adult; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D005260:Female; D005546:Forehead; D006801:Humans; D008297:Male; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000627:therapeutic use*; D015595:Skin Aging / Q000187:drug effects*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A; C545476:incobotulinumtoxinA