NCT03627468

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Botanix Pharmaceuticals · Industry
• Sex: All
• Age: 9 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, open-label, phase 3 long-term study designed to evaluate the safety, local tolerability and efficacy of sofpironium bromide gel when applied topically to the axillae. Subjects will apply the gel once daily at bedtime, to both axillae. A maximum of 300 subjects, will be randomized to receive one of two sofpironium bromide gel concentrations. Adverse events, vital signs, and local tolerability assessments will be collected at each visit. Urine pregnancy tests will be taken throughout the course of the study for women of child bearing potential. Blood and urine samples will be collected and analyzed for routine hematology, chemistry, and urinalysis parameters at specified visits. Patient-reported outcome assessments will be recorded during the study at predefined time points. The study will be comprised of a total of 17 scheduled visits to take place over a 52 week period.

Conditions

• Primary Axillary Hyperhidrosis

Interventions

Type	Name	Description
DRUG	Sofpironium Bromide Gel, 5%	Sofpironium Bromide Gel, 5%
DRUG	Sofpironium Bromide Gel, 15%	Sofpironium Bromide Gel, 15%

Timeline

• Start date: 2018-09-05
• Primary completion: 2020-01-27
• Completion: 2020-01-27
• First posted: 2018-08-13
• Last updated: 2023-05-19
• Results posted: 2023-05-19

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study