drugset
drugset / Trial / NCT03836287

Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)

NCT03836287 ↗

Phase 3 Completed 350 enrolled Botanix Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2020-10-09
Primary completion
2021-06-25
Completion
2021-06-25

Outcome

Met primary endpoint

registry analysis (other test); Active vs Vehicle; p = 0.0004; Odds Ratio (OR) 2.34 (95% CI 1.47 to 3.72); Regression, Logistic NCT03836287 ↗

registry analysis (other test); Active vs Vehicle; p = 0.0019; Mean Difference (Net) -29.71 (95% CI -48.42 to -11.00); ANCOVA NCT03836287 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject SOFPIRONIUM Small molecule 15 % Topical

Indications

No indication recorded.