title: Effects of OnabotulinumtoxinA treatment for crow's feet lines on patient-reported outcomes.
abstract: BACKGROUND
  Although millions of aesthetic procedures are performed annually, few patient-reported outcome (PRO) measures have been used in this setting.
  
  
  OBJECTIVE
  To evaluate the impact of onabotulinumtoxinA treatment for crow's feet lines (CFL) on relevant psychological variables and self-perception of age/appearance in subgroup populations.
  
  
  METHODS
  Facial Lines Outcomes (FLO-11) Questionnaire, Self-Perception of Age (SPA), and Subject Global Assessment of Change in CFL (SGA-CFL) were PRO measures administered in 2 Phase 3, double-blind placebo-controlled trials for the treatment of CFL alone or CFL/glabellar lines (GL). Patient-reported outcome measures were analyzed by subgroups (age, gender, and baseline CFL severity). Subject satisfaction with appearance was also analyzed.
  
  
  RESULTS
  Most subgroups receiving onabotulinumtoxinA demonstrated significant improvements in psychological impact (FLO-11 Items 2, 5, and 8) versus placebo at Day 30 (p ≤ .05). OnabotulinumtoxinA-treated subjects consistently rated themselves as looking younger on SPA versus placebo in all subgroups at Day 30 (p ≤ .05) and showed significant improvements in CFL appearance versus placebo at all time points on SGA-CFL. Overall, subjects were satisfied with their appearance.
  
  
  CONCLUSIONS
  OnabotulinumtoxinA-treated subjects experienced significant improvements in perceived appearance, attractiveness, tiredness, age, and satisfaction versus placebo. Subjects treated for CFL and GL experienced even greater effects.
authors.affiliation: *DeNova Research, Chicago, Illinois; †Coleman Center for Cosmetic Dermatologic Surgery, Metairie, Louisiana; ‡SkinCare Physicians, Chestnut Hill, Massachusetts; §Aalst Dermatology Clinic, Aalst, Belgium; ‖Peloton Advantage, Parsippany, New Jersey; ¶Allergen, Inc., Irvine, California.
authors.forename: Steven
authors.initials: S
authors.lastname: Dayan
authors.forename: William P
authors.initials: WP
authors.lastname: Coleman
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Dover
authors.forename: Koen
authors.initials: K
authors.lastname: De Boulle
authors.forename: James
authors.initials: J
authors.lastname: Street
authors.forename: Linda
authors.initials: L
authors.lastname: Romagnano
authors.forename: Selena
authors.initials: S
authors.lastname: Daniels
authors.forename: Jonathan W
authors.initials: JW
authors.lastname: Kowalski
authors.forename: Xiaofang
authors.initials: X
authors.lastname: Lei
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Lee
mesh_terms: D000328:Adult; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D004311:Double-Blind Method; D005123:Eye; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000627:therapeutic use*; D017060:Patient Satisfaction; D012649:Self Concept; D015595:Skin Aging / Q000187:drug effects*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A