Patient-reported outcomes with botulinum toxin type A treatment of glabellar rhytids: a double-blind, randomized, placebo-controlled study.
BACKGROUND
Global patient-reported outcomes do not evaluate specific aspects of treatment that are important to patients.


OBJECTIVE
The objective was to evaluate self-perception of age and specific outcomes that are important to patients receiving botulinum toxin type A or placebo for moderate to severe glabellar lines (using the Facial Line Outcomes Questionnaire to assess how much facial lines bother them, make them look older, detract from their facial appearance, prevent a smooth facial appearance, and make them look tired, stressed, or angry).


METHODS
In the double-blind phase of this 12-week study, 70 patients were randomly assigned to treatment with 20 U botulinum toxin type A (BOTOX Cosmetic) or placebo. At Week 4, those still with moderate or severe glabellar lines were offered open-label 20 U botulinum toxin type A.


RESULTS
Median glabellar line severity was significantly lower after botulinum toxin treatment than after placebo. Compared with placebo, botulinum toxin also resulted in significantly superior patient assessments and a greater proportion of patients considering they looked younger than their current age.


CONCLUSIONS
Botulinum toxin type A can achieve specific goals of treatment that are important to patients and help them feel that they look younger than their current age.
Fagien
Steven
S
Private Practice Aesthetic Oculoplastic Surgery, Boca Raton, Florida 33431, USA. sfagien@aol.com
Cox
Sue Ellen
SE
Finn
J Charles
JC
Werschler
W Philip
WP
Kowalski
Jonathan W
JW
D000328:Adult; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000008:administration & dosage*; D017060:Patient Satisfaction; D012649:Self Concept; D015595:Skin Aging / Q000187:drug effects*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A