At a glance
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A Multicenter, Randomized, Open-label, Phase 3 Long-term Safety Study of Topically Applied Sofpironium Bromide (BBI-4000) Gel, 5% and 15% in Subjects With Axillary Hyperhidrosis
In Brief
A Phase 3 clinical trial evaluating Sofpironium Bromide Gel, 5% and Sofpironium Bromide Gel, 15% for Primary Axillary Hyperhidrosis. Completed, enrolled 300 participants across 12 sites.
Detailed Summary
Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits, hands, and feet) affects approximately 4.8% of the US population and is believed to be caused by an overactive cholinergic response of the sweat glands. Current therapies have limited effectiveness, significant side effects, and can be invasive and costly. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis. This Phase 3 study will assess the long-term safety, tolerability, and efficacy of sofpironium bromide gel applied topically to subjects with axillary hyperhidrosis.
Study Details
Timeline
Interventions
Sofpironium Bromide Gel, 5%
Sofpironium Bromide Gel, 15%