Jean Carruthers1, Alastair Carruthers. 1. Department of Ophthalmology, University of British Columbia, Vancouver, British Columbia, Canada. jean@carruthers.net
Abstract
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. CONCLUSION: 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.
RCT Entities:
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. CONCLUSION: 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.
Authors: O P Kreyden; B Rzany; P Becker-Wegerich; C Boudny-Frey; P Carrozza-Merlani; M Hess-Schmid; B Schlagenhauff Journal: Hautarzt Date: 2015-02 Impact factor: 0.751
Authors: Hema Sundaram; Massimo Signorini; Steven Liew; Ada R Trindade de Almeida; Yan Wu; André Vieira Braz; Steven Fagien; Greg J Goodman; Gary Monheit; Hervé Raspaldo Journal: Plast Reconstr Surg Date: 2016-03 Impact factor: 4.730