A Safety, Tolerability and Preliminary Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
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ClinicalTrials.gov Identifier: NCT02058264 |
Recruitment Status :
Completed
First Posted : February 10, 2014
Last Update Posted : September 11, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hyperhidrosis | Drug: BBI-4000 | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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. |
Study Start Date : | February 2014 |
Actual Primary Completion Date : | August 2014 |
Actual Study Completion Date : | September 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Low Strength BBI-4000 and Vehicle |
Drug: BBI-4000 |
Experimental: High Strength BBI-4000 and Vehicle |
Drug: BBI-4000 |
- Percent change in the gravimetrically measured sweat production from baseline [ Time Frame: Week 2 ]
- Absolute change in the gravimetrically measured sweat production from baseline [ Time Frame: Week 2 ]
- Proportion of subjects who have a minimum of 2-grade improvement in HDSS from baseline. [ Time Frame: Week 2 ]
- Proportion of subjects who have a minimum of 1-grade improvement in HDSS from baseline [ Time Frame: Week 2 ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02058264
Dominican Republic | |
Instituto Dermatologico | |
Santo Domingo, Dominican Republic |
Study Director: | David Angulo, M.D. | Brickell Biotech, Inc. | |
Principal Investigator: | Daisy Blanco, M.D. | Instituto Dermatologico |
Responsible Party: | Brickell Biotech, Inc. |
ClinicalTrials.gov Identifier: | NCT02058264 |
Other Study ID Numbers: |
BBI-4000-CL-101 |
First Posted: | February 10, 2014 Key Record Dates |
Last Update Posted: | September 11, 2014 |
Last Verified: | September 2014 |
Hyperhidrosis Sweat Gland Diseases Skin Diseases |