NCT02336503

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

A Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Effect on Sweat Production of 3 Concentrations of Topically Applied BBI-4000 in Subjects With Axillary Hyperhidrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Botanix Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and efficacy of 3 doses of BBI-4000 and vehicle (4 treatment arms), when applied once a day for 4 weeks, 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. Participating subjects will apply BBI-4000 once a day for 4 weeks in their axillae. The 4 week treatment period will be followed by a 2 week follow-up period. Safety will be assessed through collection of vital signs, adverse events, local skin responses, hematology and serum chemistry laboratory testing and ECGs. Efficacy will be assessed using the Hyperhidrosis Disease Severity Scale (patient reported outcome) and through gravimetrically measured sweat production. PK blood samples will be taken from study subjects from selected centers.

Conditions

• Hyperhidrosis

Interventions

Type	Name	Description
DRUG	BBI-4000 Gel, 5%	BBI-4000 Gel, 5%
DRUG	BBI-4000 Gel, 10%	BBI-4000 Gel, 10%
DRUG	BBI-4000 Gel, 15%	BBI-4000 Gel, 15%
DRUG	Vehicle	Placebo, BBI-4000 Gel, 0%

Timeline

• Start date: 2015-03-10
• Primary completion: 2015-11-05
• Completion: 2015-11-05
• First posted: 2015-01-13
• Last updated: 2023-03-15
• Results posted: 2023-03-15

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study