NCT02058264

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

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Botanix Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hyperhidrosis

Interventions

Type	Name	Description
DRUG	BBI-4000

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2014-02-10
• Last updated: 2022-12-16