A single-center, dose-comparison, pilot study of botulinum neurotoxin type A in female patients with upper facial rhytids: safety and efficacy.

Author(s): Carruthers A, Carruthers J

Affiliation(s): Department of Dermatology and Skin Science, University of British Columbia, 943 W Broadway, Suite 820, Vancouver, British Columbia V5Z 4E1, Canada. alastair@carruthers.net

Publication date & source: 2009-06, J Am Acad Dermatol., 60(6):972-9.

Publication type: Comparative Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

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.