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An analysis of the efficacy of botulinum toxin A to treat glabellar lines from phase III studies


The results of five phase III multicenter, randomized, double-blind, placebo-controlled studies of botulinum A were evaluated in the treatment of glabellar lines. The primary endpoint was a response defined as a composite 2-grade improvement at day 30 from baseline in the Wrinkle Severity Rating Scale (WRVS). This is a 0-3 scale where 0 = no wrinkles and 3 = severe wrinkles. There were 720 botulinum A patients and 396 placebo patients in the analysis and doses of 50-80 U botulinum A were used. The median onset to time of response was 3 days with a median duration of 85 days with fixed dosing and 109 days for variable dosing. Similar ...

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