title: Efficacy and safety of onabotulinumtoxinA for the treatment of crows feet lines: a multicenter, randomized, controlled trial.
abstract: BACKGROUND
  This study was part of a Phase 3 program treating crow's feet lines (CFL) with onabotulinumtoxinA.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of onabotulinumtoxinA treatment of CFL.
  
  
  METHODS
  This multicenter, double-blind, placebo-controlled, 5-month study randomized subjects with moderate-to-severe CFL (maximum smile) to onabotulinumtoxinA (24 U; n = 222) or placebo (n = 223). Investigators and subjects assessed CFL severity (maximum smile and rest) using the 4-grade Facial Wrinkle Scale (FWS). Co-primary end points were investigator- and subject-assessed proportion of subjects achieving a CFL FWS grade of 0 (none) or 1 (mild) at maximum smile (Day 30). Additional efficacy end points, patient-reported outcomes, 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). Co-primary responder rates were 66.7% compared with 6.7% for investigator-assessed and 58.1% compared with 5.4% for subject-assessed response (onabotulinumtoxinA group and placebo, respectively; p < .001). A significantly greater proportion of the onabotulinumtoxinA group than placebo group achieved a 1 grade or greater improvement on the FWS (maximum smile and rest assessed by both the investigator and subject; all time points; p < .001). Most AEs were mild or moderate and did not result in discontinuations.
  
  
  CONCLUSIONS
  Treatment of moderate-to-severe CFL with onabotulinumtoxinA was effective and well tolerated.
authors.affiliation: *Department of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada; †Suzanne Bruce and Associates, PA, Houston, Texas; ‡Department of Dermatology, Vrije Universiteit Brussel, Brussels, Belgium; §The Private Clinic, Glasgow, United Kingdom; ‖Department of Dermatology, School of Medicine, University of North Carolina, Chapel Hill, Chapel Hill, North Carolina; ¶Aesthetic Solutions, Chapel Hill, North Carolina; #Scientific Communications and Information, Parsippany, New Jersey; **Allergan, Inc., Irvine, California; and ††Kythera Biopharmaceuticals Inc., Calabasas, California; and ‡‡Department of Medicine, Division of Dermatology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California.
authors.forename: Alastair
authors.initials: A
authors.lastname: Carruthers
authors.forename: Suzanne
authors.initials: S
authors.lastname: Bruce
authors.forename: Arlette
authors.initials: A
authors.lastname: de Coninck
authors.forename: Simon
authors.initials: S
authors.lastname: Connolly
authors.forename: Sue Ellen
authors.initials: SE
authors.lastname: Cox
authors.forename: Paula G
authors.initials: PG
authors.lastname: Davis
authors.forename: Antoinette
authors.initials: A
authors.lastname: Campo
authors.forename: Xiaofang
authors.initials: X
authors.lastname: Lei
authors.forename: Christine
authors.initials: C
authors.lastname: Somogyi
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Lee
authors.forename: Helen
authors.initials: H
authors.lastname: McLean
authors.forename: Frederick
authors.initials: F
authors.lastname: Beddingfield
mesh_terms: D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015595:Skin Aging / Q000187:drug effects*
chemical_list: D019274:Botulinum Toxins, Type A