Botulinum Toxin Type A in the Treatment of Primary Axillary Hyperhidrosis:A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety in Chinese Patients.

Abstract

The efficacy and safety of botulinum toxin type A (BoNTA) treatment for primary axillary hyperhidrosis (PAH) have not been explored in the Chinese population. The objective was to evaluate efficacy and safety of 1 intradermal BoNTA injection in Chinese PAH cases. This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study. Patients were randomized to an experimental group or the control group at a ratio of 3:1 and received either BoNTA or a placebo once. The primary efficacy endpoint was the proportion of patients who experienced an over 50% reduction in axillary sweat weight at Week 4 posttreatment compared to baseline. The key secondary efficacy endpoints were the percentage changes in axillary sweat weight at Weeks 1, 4, 8, and 16 posttreatment. A total of 344 patients were randomized to the experimental group (n = 258) or the control group (n = 86). The proportions of patients who experienced an over 50% reduction in axillary sweat weight at Week 4 posttreatment were 83.72% (216/258) in the experimental group and 55.81% (48/86) in the control group, respectively. The between-group difference was 27.91% (P < .001). BoNTA treatment yielded a significant reduction in axillary sweat weight, hyperhidrotic area, hyperhidrosis disease severity scale (HDSS) scores, and grade of bromhidrosis. The patients in the experimental group reported significantly higher satisfaction scores than those in the control group. BoNTA treatment was well tolerated. Neither group experienced suspected unexpected serious adverse reactions, or adverse events or adverse drug reactions leading to withdrawal or death. One intradermal 50-U BoNTA treatment led to a significant reduction in axillary sweat weight, axillary hyperhidrotic area, HDSS scores, and axillary bromhidrosis grades in Chinese PAH patients. The therapeutic effect was maintained for 16 weeks posttreatment, with a favorable safety profile.