Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)
Status:
Completed
Trial end date:
2021-06-25
Target enrollment:
Participant gender:
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 safety and efficacy of sofpironium bromide, 15% gel versus
vehicle (2 treatment arms), applied for the treatment of axillary hyperhidrosis.