Botulinum Toxin Type A for the Treatment of Glabellar Lines in Chinese: A Double-Blind, Randomized, Placebo-Controlled Study

BACKGROUND This is the first well-controlled study of the use of botulinum toxin type A (BoNTA) for glabellar lines in China. OBJECTIVES To evaluate the safety and efficacy of BoNTA in the treatment of glabellar lines in Chinese subjects. MATERIALS AND METHODS A total of 227 subjects received a single treatment in a 3:1 randomization ratio of BoNTA (20 U):placebo and were observed for 120 days after injection. Effective outcome measures included investigator's rating of wrinkle severity at maximum frown and rest and subjects' global assessment and self-perception of age. RESULTS A significantly higher responder rate at maximum frown, ranging from 94.1% at day 30 to 52.9% at day 120, was noted in the BoNTA group. The proportion of subjects with none or mild glabellar lines at rest was 66.7% in the BoNTA group at day 30. Most (95.3%) of the subjects treated with BoNTA reported better than 50% improvement at day 30, and self-perception of age was less than chronological age. There were no statistically significant differences in adverse events reported between the two groups (p=.06). CONCLUSION A single treatment of 20 U of BoNTA was effective and safe in reducing glabellar lines in Chinese subjects. GlaxoSmithKline provided funding and study material.