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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Hyperhidrosis

Intervention / Treatment
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* Drug: BBI-4000


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Strength BBI-4000 and Vehicle<br> | Drug: BBI-4000<br> <br> |
| Experimental: High Strength BBI-4000 and Vehicle<br> | Drug: BBI-4000<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in the gravimetrically measured sweat production from baseline |  | Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in the gravimetrically measured sweat production from baseline |  | Week 2 | 
| Proportion of subjects who have a minimum of 2-grade improvement in HDSS from baseline. |  | Week 2 | 
| Proportion of subjects who have a minimum of 1-grade improvement in HDSS from baseline |  | Week 2 |