A single-center, dose-comparison, pilot study of botulinum neurotoxin type A in female patients with upper facial rhytids: Safety and efficacy - 08/08/11

Doi : 10.1016/j.jaad.2009.01.005

Alastair Carruthers, MD ^a,^⁎ , Jean Carruthers, MD ^b
^a Department of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada
^b Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada

Reprint requests: Alastair Carruthers, MD, Departments of Dermatology and Skin Science, University of British Columbia, 943 W Broadway, Suite 820, Vancouver, British Columbia V5Z 4E1, Canada.

Abstract

Background

Treating multiple upper facial rhytids at one time is common, but has not been researched extensively.

Objective

We sought to compare the safety, efficacy, and effect duration of 3 botulinum neurotoxin type A (BoNTA) doses in treating multiple upper facial rhytids.

Method

Sixty women, randomized to 32, 64, or 96 U total doses, were assessed at baseline, week 2, week 4, then every 4 weeks. The primary efficacy measure was proportion of responders on the patient global assessment of improvement. Adverse events (AEs) were monitored.

Results

All BoNTA doses were effective and safe. Significant between-group differences occurred in the percentage of responders (96 U: 71%, 64 U: 61%, 32 U: 26%; P = .0007). Adverse events did not differ significantly among groups; no serious treatment-related adverse events occurred.

Limitations

BoNTA doses were fixed and not tailored to individuals.

Conclusion

These results confirm the efficacy and safety of 3 doses of BoNTA for treating upper facial rhytids in female patients; higher doses afforded greater benefit.

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Abbreviations used : AE, BoNTA, FWS, PGA, TOGA

Plan

Data analysis and statistical methods

Demographics and baseline characteristics

Results

PGA of improvement and duration of response

Discussion

	Supported by a grant from Allergan Inc, Irvine, California.
	Disclosure: Drs Carruthers and Carruthers are consultants and investigators for and receive honoraria from Allergan Inc, which sponsored the study and the preparation of the article. They are also consultants and investigators for Merz GmbH and Solstice Neurosciences Inc.