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

Hyperhidrosis Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Hyperhidrosis

• NCT number: NCT02336503
• Study type: Interventional
• Source: Botanix Pharmaceuticals
• Status: Completed
• Phase: Phase 2
• Start date: March 10, 2015
• Completion date: November 5, 2015