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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brickell Biotech, Inc.

Criteria

Inclusion Criteria:

• Male or Female subjects from 18 to 45 years of age in good general health.

• Primary axillary hyperhidrosis of at least 6 months duration.

• Hyperhidrosis Disease Severity Score (HDSS) of 3 or 4 at baseline.

• Gravimetric test at baseline indicating at least 100mg of axillary sweat production in a 5 min period.

• Use of a medically appropriate contraceptive method.

Exclusion Criteria:

• Prior axillary use of botulinum toxin within 2 years of study entry.

• Prior iontophoresis treatment for axillary hyperhidrosis within 12 weeks of study entry.

• Prior surgical procedures for hyperhidrosis or surgical procedures in the axillary areas for any reason.

• Use of anticholinergic treatment, beta-blocker, alpha-adrenergic or other prescription treatment for hyperhidrosis.

• History of diabetes mellitus, thyroid disease, malignancy, glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, prostate hypertrophy, neurological conditions or cardiac abnormalities.

• Known condition that may cause hyperhidrosis.

• Use of an investigational drug within 30 days prior to entry into this study.