title: Long-term results for incobotulinumtoxinA in the treatment of glabellar frown lines.
abstract: BACKGROUND
  IncobotulinumtoxinA has been approved for treatment of glabellar frown lines (GFL) in the United States, all major European markets, South Korea, and Argentina and in Russia and Mexico for the treatment of mimic wrinkles and hyperkinetic facial lines, respectively.
  
  
  OBJECTIVE
  Prospective, 2-year, open-label, multicenter, repeat-dose, Phase III trial investigating the safety and efficacy of incobotulinumtoxinA for the treatment of GFL.
  
  
  METHODS
  Subjects with moderate or severe GFL on the Facial Wrinkle Scale (FWS), enrolled from previous trials, were treated with 20 U of incobotulinumtoxinA per cycle (up to eight treatment cycles, treatment interval at least 85 days). Efficacy was measured according to the investigator-assessed percentage of responders on the FWS (subjects with a score of 0 or 1) at rest and maximum frown on Day 30 of each cycle, subject assessments, and onset and duration of treatment effect.
  
  
  RESULTS
  In 796 subjects, 77% to 88% were responders at rest, and 79% to 90% were responders at maximum frown. Onset was rapid; subjects reported effects in the first few days after treatment. No new tolerability or safety concerns were reported.
  
  
  CONCLUSIONS
  IncobotulinumtoxinA injections were well tolerated and resulted in efficacy in the treatment of GFL for up to 2 years.
authors.affiliation: Division of Evidence-Based Medicine, Klinik für Dermatologie, Charité Universitätsmedizin Berlin, Berlin, Germany. berthold.rzany@charite.de
authors.forename: Berthold
authors.initials: B
authors.lastname: Rzany
authors.forename: Timothy Corcoran
authors.initials: TC
authors.lastname: Flynn
authors.forename: Andrea
authors.initials: A
authors.lastname: Schlöbe
authors.forename: Moritz
authors.initials: M
authors.lastname: Heinz
authors.forename: Laura
authors.initials: L
authors.lastname: Harrington
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects; D005138:Eyebrows; D005260:Female; D005546:Forehead; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009498:Neurotoxins / Q000008:administration & dosage* / Q000009:adverse effects; D015595:Skin Aging / Q000187:drug effects*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D009498:Neurotoxins; D019274:Botulinum Toxins, Type A; C545476:incobotulinumtoxinA