title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Repeated OnabotulinumtoxinA Treatments in Subjects With Crow's Feet Lines and Glabellar Lines.
abstract: BACKGROUND
  This is the third study in a Phase 3 program evaluating onabotulinumtoxinA treatment of crow's feet lines (CFL).
  
  
  OBJECTIVE
  To assess the efficacy and safety of repeated onabotulinumtoxinA treatments of CFL alone or with glabellar lines (GL) in subjects with moderate-to-severe CFL and GL (maximum smile).
  
  
  METHODS
  This 5-month extension of a 7-month study randomized subjects who originally received onabotulinumtoxinA 24 U (CFL only; n = 227) or 44 U (24 U for CFL + 20 U for GL; n = 260) to retreatment with the same dose. Placebo-treated subjects were rerandomized to onabotulinumtoxinA 44 U (n = 101) or placebo (n = 96). Primary efficacy end point (Day 30) was the proportion of subjects who achieved a CFL severity rating of none or mild (maximum smile) on the investigator-assessed Facial Wrinkle Scale (FWS). Additional efficacy end points and adverse events were evaluated.
  
  
  RESULTS
  Responder rates (primary end point) were significantly greater in onabotulinumtoxinA-treated groups (24 U: 56.5%; 44 U: 63.6%; placebo: 1.1%; p < .001). Improvements on most patient-reported outcomes (PROs) favored the 44-U group over the 24-U group. Adverse events did not differ among groups; most were mild or moderate.
  
  
  CONCLUSIONS
  Repeated onabotulinumtoxinA treatments significantly reduce CFL severity based on FWS and PROs. Adverse event profiles remain consistent with approved GL labeling.
authors.affiliation: *Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada; †Division of Dermatology, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California; ‡Department of Dermatology, Yale University School of Medicine, New Haven, Connecticut; §Department of Dermatology, Tulane University School of Medicine, New Orleans, Louisiana; ‖Division of Dermatology, University of Toronto, Toronto, Ontario, Canada; ¶Allergan, Inc., Irvine, California; #SCI Scientific Communications & Information, Parsippany, New Jersey. C. Somogyi and F. C. Beddingfield are now at Kythera Biopharmaceuticals, Inc., Calabasas, California.
authors.forename: Jean
authors.initials: J
authors.lastname: Carruthers
authors.forename: Alexander
authors.initials: A
authors.lastname: Rivkin
authors.forename: Lisa
authors.initials: L
authors.lastname: Donofrio
authors.forename: Vince
authors.initials: V
authors.lastname: Bertucci
authors.forename: Chris
authors.initials: C
authors.lastname: Somogyi
authors.forename: Xiaofang
authors.initials: X
authors.lastname: Lei
authors.forename: Paula G
authors.initials: PG
authors.lastname: Davis
authors.forename: Antoinette
authors.initials: A
authors.lastname: Campo
authors.forename: Frederick C
authors.initials: FC
authors.lastname: Beddingfield
mesh_terms: D000328:Adult; D001763:Blepharoptosis / Q000139:chemically induced; D019274:Botulinum Toxins, Type A / Q000009:adverse effects / Q000627:therapeutic use*; D003357:Cosmetic Techniques / Q000009:adverse effects; 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*; D017060:Patient Satisfaction; D012649:Self Concept; D015595:Skin Aging / Q000187:drug effects*; D016896:Treatment Outcome
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A