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

Study Overview
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Brief Summary
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To assess the safety and efficacy of 3 doses of BBI-4000 and vehicle (4 treatment arms), when applied once a day for 4 weeks, for the treatment of axillary hyperhidrosis.

Detailed Description
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This is a Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of 3 concentrations of Topically Applied BBI-4000 in Subjects with Axillary Hyperhidrosis. Participating subjects will apply BBI-4000 once a day for 4 weeks in their axillae. The 4 week treatment period will be followed by a 2 week follow-up period. Safety will be assessed through collection of vital signs, adverse events, local skin responses, hematology and serum chemistry laboratory testing and ECGs. Efficacy will be assessed using the Hyperhidrosis Disease Severity Scale (patient reported outcome) and through gravimetrically measured sweat production. PK blood samples will be taken from study subjects from selected centers.

Official Title
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A Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Effect on Sweat Production of 3 Concentrations of Topically Applied BBI-4000 in Subjects With Axillary Hyperhidrosis

Conditions
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Hyperhidrosis

Intervention / Treatment
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* Drug: BBI-4000 Gel, 5%
* Drug: BBI-4000 Gel, 10%
* Drug: BBI-4000 Gel, 15%
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary axillary hyperhidrosis of at least 6 months's duration Hyperhidrosis disease severity score of 3 or 4 at baseline Gravimetric test at baseline indicating at least 50 mg of sweat production at rest in each axilla, in 5 minutes (room temperature) Willing to refrain from using any other antiperspirant agent for the duration of the study. Females of childbearing potential must agree to use a medically acceptable method of contraception while participating in the study. Exclusion Criteria: Any skin or subcutaneous tissue conditions in the axilla or near the axillary area, other than hyperhidrosis. Prior use of any prohibited medication(s) or procedure(s) within the specified timeframe, including: Botulinum toxin to the axillary area within 1 year of the baseline visit. Axillary iontophoresis within 12 weeks of baseline visit. Axillary thermolysis, sympathectomy or surgical procedures of the axillary area at any time in the past. Use of systemic and/or topical anticholinergic treatment within 30 days of the baseline visit. Subjects with hyperhidrosis symptoms initiated or exacerbated with their menopause. Subjects with history of diabetes mellitus, renal impairment, hepatic impairment, thyroid disease, malignancy, glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, benign prostatic hyperplasia (BPH), neurological conditions, psychiatric conditions, Sjögren's syndrome, Sicca syndrome, or cardiac abnormalities that may alter normal sweat production or may be exacerbated by the use of anticholinergics. Subjects with known hypersensitivity to glycopyrrolate, anticholinergics, or any of the components of the topical formulation. Pregnant or lactating women. Use of an investigational drug within 30 days prior to the baseline visit. Prior treatment with the study drug in a previous trial. Any major illness within 30 days before the screening examination. Any other condition or laboratory abnormality that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with the assessments included in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BBI-4000 Gel, 5%<br>Low concentration of BBI-4000; BBI-4000 Gel, 5% | Drug: BBI-4000 Gel, 5%<br>* BBI-4000 Gel, 5%<br>* Other names: BBI-4000 Low Dose;|
| Experimental: BBI-4000 Gel, 10%<br>Middle concentration of BBI-4000; BBI-4000 Gel, 10% | Drug: BBI-4000 Gel, 10%<br>* BBI-4000 Gel, 10%<br>* Other names: BBI-4000 Middle Dose;|
| Experimental: BBI-4000 Gel, 15%<br>High concentration of BBI-4000; BBI-4000 Gel, 15% | Drug: BBI-4000 Gel, 15%<br>* BBI-4000 Gel, 15%<br>* Other names: BBI-4000 High Dose;|
| Placebo Comparator: Vehicle<br>Vehicle (placebo); BBI-4000 Gel, 0% | Drug: Vehicle<br>* Placebo, BBI-4000 Gel, 0%<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Achieving at Least 2-point Decrease in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4 | Severity is scored with increasing scale, scores 1-4 where minimal severity is scored: 1=My sweating is never noticeable and never interferes with my daily activities and most severe score is: 4=My sweating is intolerable and always interferes with my daily activities | Baseline through Week 4 (Day 29) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Achieving at Least 1-point Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline to Week 4 | Severity is scored with increasing scale, scores 1-4 where minimal severity is scored: 1=My sweating is never noticeable and never interferes with my daily activities and most severe score is: 4=My sweating is intolerable and always interferes with my daily activities | Baseline through Week 4 (Day 29) | 
| Absolute Change in Gravimetrically Measured Sweat Production From Baseline to Week 4 (Day 29) | Sweat production unit of measure was weight-based (mg); absolute change was calculated by adding the left and right axillae sweat weights and calculating absolute change by subtracting day 29 from baseline sweat weights | Baseline through Week 4 (Day 29) | 
| Percent Change in Gravimetrically Measured Sweat Production From Baseline to Week 4 | Randomized participants that provided samples for gravimetric sweat measures, baseline and day 29; Percent Change was calculated by dividing absolute change by baseline gravimetric measurement x 100% | Baseline through Week 4 (Day 29) |