A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis

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. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis. This Phase 2 study will assess the long-term safety, tolerability, pharmacokinetics and efficacy of sofpironium bromide gel applied topically to pediatric subjects with axillary hyperhidrosis.

Timeline

Start

2018-12-21

Primary completion

2019-09-06

Completion

2019-09-06

Drugs

Indications