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

Hyperhidrosis Clinical Trial

Official title:
A Randomized, Double Blinded, Vehicle-Controlled Study to Evaluate the Safety and the Effect on Sweat Production of Topically Applied BBI-4000 in Subjects With Hyperhidrosis.

Clinical Trial Summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and treatment effect of BBI-4000 when topically applied to subjects with axillary hyperhidrosis.

Clinical Trial Description

This is a randomized, vehicle controlled, double blind study in subjects with axillary hyperhidrosis designed to assess the safety, tolerability and the effect on sweat production of topically applied BBI-4000 for 14 days. Safety will be assessed though vital signs, physical exam, adverse events, local skin reactions and laboratory tests (blood chemistry and hematology). Efficacy will be assessed though the gravimetrically measured sweat production and the Hyperhidrosis Disease Severity Score (HDSS). Pharmacokinetic information will also be collected. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02058264
Study type Interventional
Source Botanix Pharmaceuticals
Contact
Status Completed
Phase Phase 1
Start date February 2014
Completion date September 2014
View Details
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