Botulinum toxin type A in the treatment of primary axillary hyperhidrosis: a 52-week multicenter double-blind, randomized, placebo-controlled study of efficacy and safety.

Abstract

The long-term effects of botulinum toxin type A (BoNTA) on the global impairment associated with severe primary axillary hyperhidrosis have not been comprehensively assessed relative to placebo. To assess the efficacy and safety of 2 dosages of BoNTA compared with placebo in subjects with primary axillary hyperhidrosis. Subjects (N = 322) were randomized to the use of BoNTA (75 U or 50 U/axilla) or placebo in this 52-week, multicenter, double-blind study. BoNTA treatment significantly reduced daily activity limitations at 4 weeks after injection. A 2-point improvement on the 4-point Hyperhidrosis Disease Severity Scale (HDSS) was reported in 75% of subjects in the 75-U and 50-U BoNTA groups and in 25% of the placebo group (P < .001). Improvements in HDSS scores were corroborated by gravimetric results. The median duration of effect was 197 days, 205 days, and 96 days in the 75-U, 50-U, and placebo groups, respectively. BoNTA was well tolerated. The effect of total surface area involvement on treatment efficacy was not evaluated. BoNTA treatment effectively reduces the symptoms of primary axillary hyperhidrosis and is well tolerated.