Hyperhidrosis | A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
Hyperhidrosis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Low Strength BBI-4000 and Vehicle
High Strength BBI-4000 and Vehicle
Start Date: February 2014
Completed Date: September 2014
Phase: Phase 1
Primary Outcome: Percent change in the gravimetrically measured sweat production from baseline
Secondary Outcome: Absolute change in the gravimetrically measured sweat production from baseline
Study sponsors, principal investigator, and references
Principal Investigator: David Angulo, M.D.
Lead Sponsor: Brickell Biotech, Inc.