Botulinum toxin type A treatment of multiple upper facial sites: patient-reported outcomes.
BACKGROUND
Aesthetic treatment planning must address subjects' goals and include subject-reported outcomes.


OBJECTIVE
The objective was to compare the effect of botulinum neurotoxin type A (BoNTA) with placebo on subject-reported outcomes and to assess the utility of 64 U of BoNTA to treat the entire upper face.


METHODS
Forty female subjects were randomized to receive 64 U of BoNTA or identical placebo injections (double-masked) divided among 16 sites of the upper face and were followed for 12 weeks. Subjects unimproved at Week 4 were eligible for open-label BoNTA treatment and were followed through Week 16. Main outcome measures were scores on seven items of the Facial Line Outcomes Questionnaire (FLO-7) and results on the Self-Perception of Age (SPA) for assessing age of appearance relative to actual age.


RESULTS
BoNTA treatment resulted in significant improvements on the FLO-7 scores that were maintained throughout the study. BoNTA treatment also reduced age of appearance in a majority of subjects. Placebo had no effects on any measure. No serious adverse events occurred.


CONCLUSIONS
Sixty-four-unit BoNTA treatment of upper facial rhytids safely and significantly improves subject-reported outcomes, as measured by the FLO-7 and SPA, and results in a younger, more satisfying, relaxed appearance.
Carruthers
Jean
J
Department of Ophthalmology, University of British Columbia, Vancouver, British Columbia, Canada. jean@carruthers.net
Carruthers
Alastair
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage*; D004311:Double-Blind Method; D005145:Face; D005260:Female; D006801:Humans; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000008:administration & dosage*; D017060:Patient Satisfaction; D011446:Prospective Studies; D015595:Skin Aging / Q000187:drug effects*
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A