title: Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Upper Facial Lines: Results From a Randomized, Double-Blind, Placebo-Controlled, Phase III Study.
abstract: BACKGROUND
  Treating upper facial lines (UFL)-a combination of glabellar frown lines (GFL), horizontal forehead lines (HFL), and lateral periorbital lines (LPL)-is a common aesthetic practice.
  
  
  OBJECTIVE
  To provide the first placebo-controlled evidence of the efficacy and safety of incobotulinumtoxinA for UFL.
  
  
  METHODS
  Healthy subjects (≥18 years) with moderate-to-severe GFL, HFL, and LPL on the Merz Aesthetics Scales (MAS) at maximum contraction were randomized to incobotulinumtoxinA or placebo. For incobotulinumtoxinA, 54 to 64 U were administered (GFL, 20 U; HFL, 10-20 U; LPL, 24 U). Investigator-assessed MAS scores were evaluated for each area at maximum contraction on Day 30, both separately (responder = score of "none" [0] or "mild" [1]) and combined (UFL; sum score ≤3). Adverse events were recorded until 120 ± 7 days after treatment.
  
  
  RESULTS
  Overall, 156 subjects were treated (incobotulinumtoxinA: 105; placebo: 51). On Day 30 at maximum contraction, a significant (p ≤ .0001) effect of incobotulinumtoxinA versus placebo for GFL (84.5% vs 0.0%, respectively), HFL (70.9% vs 2.1%), LPL (64.1% vs 2.1%), and UFL combination (55.3% vs 0.0%) was demonstrated for investigator-assessed "none" or "mild" scores. Two cases of mild eyelid ptosis occurred with incobotulinumtoxinA.
  
  
  CONCLUSIONS
  IncobotulinumtoxinA demonstrated significant efficacy in treating GFL, HFL, and LPL separately and combined, as well as a good safety profile.
authors.affiliation: *Division of Cosmetic Science, Department of Chemistry, University of Hamburg, Hamburg, Germany; †Rzany & Hund Private Practice, Berlin, Germany; ‡Prager & Partner Private Practice, Hamburg, Germany; §SCI Scientific Communications and Information, Oxford, United Kingdom; ‖Expert2Expert, Paris, France; ¶London Bridge Plastic Surgery & Aesthetic Clinic, London, United Kingdom.
authors.forename: Martina
authors.initials: M
authors.lastname: Kerscher
authors.forename: Berthold
authors.initials: B
authors.lastname: Rzany
authors.forename: Welf
authors.initials: W
authors.lastname: Prager
authors.forename: Catriona
authors.initials: C
authors.lastname: Turnbull
authors.forename: Patrick
authors.initials: P
authors.lastname: Trevidic
authors.forename: Christopher
authors.initials: C
authors.lastname: Inglefield
mesh_terms: D000328:Adult; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D004311:Double-Blind Method; D005145:Face; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000627:therapeutic use*; D011446:Prospective Studies; D015595:Skin Aging / Q000187:drug effects*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A; C545476:incobotulinumtoxinA