title: Efficacy and safety of onabotulinumtoxinA for treating crow's feet lines alone or in combination with glabellar lines: a multicenter, randomized, controlled trial.
abstract: BACKGROUND
  This was the second study in a Phase 3 program treating crow's feet lines (CFL) with onabotulinumtoxinA.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of onabotulinumtoxinA treatment of CFL alone or with glabellar lines (GL).
  
  
  METHODS
  This multicenter, double-blind, placebo-controlled, repeat treatment, 7-month study randomized subjects with moderate-to-severe CFL and GL (maximum contraction) to onabotulinumtoxinA 44 U (CFL: 24 U, GL: 20 U; n = 305), onabotulinumtoxinA 24 U (CFL: 24 U, GL: placebo; n = 306), or placebo (n = 306). Coprimary end points were investigator-assessed and subject-assessed proportion of subjects achieving a CFL Facial Wrinkle Scale Grade of 0 or 1 (maximum smile; Day 30, Cycle 1). Additional efficacy end points and safety/adverse events (AEs) were evaluated.
  
  
  RESULTS
  All primary and secondary end points were achieved; statistically significant differences favored onabotulinumtoxinA (p < .001, all comparisons vs placebo). Investigator and subject responder rates were: CFL, 54.9% and 45.8%; CFL + GL, 59.0% and 48.5%; and placebo, 3.3% (both), respectively. Responder rates on other end points also significantly favored onabotulinumtoxinA treatments. Most AEs were mild or moderate. Two subjects discontinued: 1 serious AE unrelated to treatment (myocardial infarction) and 1 treatment-related AE (injection site pain).
  
  
  CONCLUSIONS
  OnabotulinumtoxinA was effective and well tolerated for treating moderate-to-severe CFL alone or in combination with GL.
authors.affiliation: *Private Clinic, Hautok, Munich, Germany; †Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, BC, Canada; ‡Private Practice, Boca Raton, Florida; §Department of Dermatology, Tulane University School of Medicine, New Orleans, Louisiana; ‖Private Practice, New Orleans, Louisiana; ¶Centre de Chirurgie Esthétique du Cap d'Antibes, Cap d'Antibes, France; #Division of Dermatology, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California; **Allergan, Inc., Irvine, California; ††SCI Scientific Communications and Information, Parsippany, New Jersey. Dr. Beddingfield and Ms. Somogyi are now at Kythera Biopharmaceuticals, Inc., Calabasas, California.
authors.forename: Marion
authors.initials: M
authors.lastname: Moers-Carpi
authors.forename: Jean
authors.initials: J
authors.lastname: Carruthers
authors.forename: Steven
authors.initials: S
authors.lastname: Fagien
authors.forename: Mary
authors.initials: M
authors.lastname: Lupo
authors.forename: Henry
authors.initials: H
authors.lastname: Delmar
authors.forename: Derek
authors.initials: D
authors.lastname: Jones
authors.forename: Christine
authors.initials: C
authors.lastname: Somogyi
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Lee
authors.forename: Xiaofang
authors.initials: X
authors.lastname: Lei
authors.forename: Suzanne
authors.initials: S
authors.lastname: MacKinnon
authors.forename: Paula G
authors.initials: PG
authors.lastname: Davis
authors.forename: Ramana
authors.initials: R
authors.lastname: Yalamanchili
authors.forename: Antoinette
authors.initials: A
authors.lastname: Campo
authors.forename: Frederick C
authors.initials: FC
authors.lastname: Beddingfield
mesh_terms: D000328:Adult; D019274:Botulinum Toxins, Type A / Q000009:adverse effects / Q000627:therapeutic use*; D003357:Cosmetic Techniques / Q000009:adverse effects / Q000523:psychology; D004311:Double-Blind Method; D005123:Eye; D005260:Female; D005546:Forehead; D006261:Headache / Q000139:chemically induced; D006406:Hematoma / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D010146:Pain / Q000139:chemically induced; D017060:Patient Satisfaction; D012649:Self Concept; D015595:Skin Aging; D016896:Treatment Outcome
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A