title: Multicenter, randomized, phase III study of a single dose of incobotulinumtoxinA, free from complexing proteins, in the treatment of glabellar frown lines.
abstract: BACKGROUND
  Botulinum toxin type A is a proven, effective aesthetic treatment for glabellar frown lines. IncobotulinumtoxinA (NT 201, Xeomin/Xeomeen/Bocouture, Merz Pharmaceuticals GmbH, Frankfurt, Germany) is a 150-kDa botulinum toxin type A free of complexing proteins.
  
  
  OBJECTIVE
  To assess the efficacy and safety of incobotulinumtoxinA in a randomized, double-blind, placebo-controlled, Phase III study in patients with moderate to severe glabellar frown lines.
  
  
  METHODS
  Two hundred seventy-six patients were randomized 2:1 to receive a single injection of 20 U of incobotulinumtoxinA or placebo, respectively. Efficacy was assessed at day 30 using a Food and Drug Administration-mandated composite endpoint; a responder was defined as a patient with a 2-point or greater improvement in glabellar frown lines on a 4-point scale as assessed by investigator and patient. Safety was assessed periodically through Day 120.
  
  
  RESULTS
  Treatment with a single dose of incobotulinumtoxinA was significantly superior to placebo in the treatment of glabellar frown lines at Day 30 using the composite endpoint (p < .001), with investigators and patients assessing glabellar frown lines as significantly more improved after incobotulinumtoxinA injection than with placebo (p < .001). IncobotulinumtoxinA was well tolerated.
  
  
  CONCLUSIONS
  A single dose of 20 U of incobotulinumtoxinA demonstrated efficacy and safety in the treatment of glabellar frown lines using new Food and Drug Administration efficacy variables.
authors: Carruthers Clinical Research, Vancouver, British Columbia, Canada.
authors: Alastair
authors: A
authors: Carruthers
authors: Jean
authors: J
authors: Carruthers
authors: William P
authors: WP
authors: Coleman
authors: Lisa
authors: L
authors: Donofrio
authors: Timothy
authors: T
authors: Flynn
authors: Michael
authors: M
authors: Gold
authors: Moritz
authors: M
authors: Heinz
authors: Laura
authors: L
authors: Harrington
authors: Derek
authors: D
authors: Jones
authors: David
authors: D
authors: McDaniel
authors: Thomas
authors: T
authors: Rohrer
authors: Andrea
authors: A
authors: Schlöbe
authors: Nowell
authors: N
authors: Solish
authors: Robert A
authors: RA
authors: Weiss
mesh_terms: D019274:Botulinum Toxins, Type A / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005546:Forehead; D006801:Humans; D008297:Male; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015595:Skin Aging / Q000187:drug effects*
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A; C545476:incobotulinumtoxinA