title: A randomized, placebo-controlled, double-blind phase III trial investigating the efficacy and safety of incobotulinumtoxinA in the treatment of glabellar frown lines using a stringent composite endpoint.
abstract: BACKGROUND
  A prospective, randomized, double-blind, multicenter, Phase III trial of incobotulinumtoxinA using new Food and Drug Administration endpoints.
  
  
  OBJECTIVE
  To investigate the efficacy and safety of a single dose of incobotulinumtoxinA for the treatment of glabellar frown lines.
  
  
  METHODS
  Two hundred seventy-one subjects with moderate to severe glabellar frown lines at maximum frown-as assessed by an investigator according to the facial wrinkle scale (FWS)-were randomized 2:1 to receive one treatment of 20 U of incobotulinumtoxinA or placebo, respectively, and assessed over 120 days. The primary efficacy variable was a composite endpoint consisting of patients who were 2-point or more responders at maximum frown on Day 30 according to the investigator's rating on the FWS, and 2-point or more responders at maximum frown on Day 30 according to the patient's assessment on a 4-point scale. Safety analyses were performed throughout the study.
  
  
  RESULTS
  IncobotulinumtoxinA was statistically significantly more efficacious than placebo using a new rigorous composite endpoint (p < .0001).
  
  
  CONCLUSIONS
  A single dose of 20 U of incobotulinumtoxinA is superior to placebo in the treatment of glabellar frown lines at Day 30 and is well-tolerated.
authors.affiliation: Laser and Skin Surgery Center of Indiana, Carmel, Indiana 46032, USA. cwmhanke@thelassi.com
authors.forename: C William
authors.initials: CW
authors.lastname: Hanke
authors.forename: Rhoda S
authors.initials: RS
authors.lastname: Narins
authors.forename: Fredric
authors.initials: F
authors.lastname: Brandt
authors.forename: Joel L
authors.initials: JL
authors.lastname: Cohen
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Donofrio
authors.forename: Jeanine
authors.initials: J
authors.lastname: Downie
authors.forename: Moritz
authors.initials: M
authors.lastname: Heinz
authors.forename: Laura
authors.initials: L
authors.lastname: Harrington
authors.forename: David H
authors.initials: DH
authors.lastname: McDaniel
authors.forename: Mark
authors.initials: M
authors.lastname: Nestor
authors.forename: Joel
authors.initials: J
authors.lastname: Schlessinger
authors.forename: Andrea
authors.initials: A
authors.lastname: Schlöbe
authors.forename: Amy
authors.initials: A
authors.lastname: Taub
authors.forename: Robert A
authors.initials: RA
authors.lastname: Weiss
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects; D003357:Cosmetic Techniques; D004311:Double-Blind Method; D005260:Female; D005546:Forehead; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015595:Skin Aging / Q000187:drug effects*; D055815:Young Adult
chemical_list: D019274:Botulinum Toxins, Type A; C545476:incobotulinumtoxinA