NCT03024255

A Confirmatory Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis

A Multicenter, Randomized, Double-Blinded, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of 3 Concentrations of Topically Applied BBI-4000 (Sofpironium Bromide) Gel in Subjects With Axillary Hyperhidrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 227 (actual)
• Sponsor: Botanix Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to assess the safety and efficacy of 3 concentrations of BBI-4000 and vehicle (4 treatment arms), applied for the treatment of axillary hyperhidrosis.

Detailed description

This is a Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of 3 concentrations of Topically Applied BBI-4000 in Subjects with Axillary Hyperhidrosis. Safety will be assessed through collection of vital signs, adverse events, local skin responses, hematology, serum chemistry laboratory testing and urinalysis.

Conditions

• Hyperhidrosis

Interventions

Type	Name	Description
DRUG	BBI-4000 gel, 5%	BBI-4000 gel, 5% applied once to each axilla daily
DRUG	BBI-4000 gel, 10%	BBI-4000 gel, 10% applied once to each axilla daily
DRUG	BBI-4000 gel, 15%	BBI-4000 gel, 15% applied once to each axilla daily
DRUG	Vehicle (Placebo)	Placebo, applied once to each axilla daily

Timeline

• Start date: 2016-12-22
• Primary completion: 2017-09-19
• Completion: 2017-09-19
• First posted: 2017-01-18
• Last updated: 2023-05-16
• Results posted: 2023-05-16