Safety and Efficacy of an Anticholinergic Agent for Treatment of Primary Axillary Hyperhidrosis

Study Overview
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Brief Summary
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This Phase 2 study is designed to evaluate multiple doses of an anticholinergic-containing medication and identify the dose or doses that may effectively reduce axillary sweating in hyperhidrotic subjects. The anticholinergic agent being studied is designated WL8713.

Official Title
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A Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of An Anticholinergic Agent for the Treatment of Primary Axillary Hyperhidrosis

Conditions
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Hyperhidrosis

Intervention / Treatment
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* Drug: WL8713, 6 mg
* Drug: WL8713, 12 mg
* Drug: WL8713, 18 mg
* Drug: WL8713, 24 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers with primary axillary hyperhidrosis Poor quality of life rating on the Hyperhidrosis Disease Severity Scale (score of 3 or 4) Has a baseline gravimetric measurement of spontaneous resting sweat production of ≥100 mg/10 min at room at room temperature in at least one axilla Meets at least two of the following criteria (self-reported): sweating is bilateral and symmetrical excessive sweating impairs daily activities subject experiences at least one sweating episode per week excessive sweating onset was earlier than age 25 years has a positive family history for excessive sweating cessation of sweating during sleep

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: WL8713, 6 mg<br>6 mg WL8713 administered daily | Drug: WL8713, 6 mg<br> <br> |
| Experimental: WL8713, 12 mg<br>12 mg WL8713 administered daily | Drug: WL8713, 12 mg<br> <br> |
| Experimental: WL8713, 18 mg<br>18 mg WL8713 administered daily | Drug: WL8713, 18 mg<br> <br> |
| Experimental: WL8713, 24 mg<br>24 mg WL8713 administered daily | Drug: WL8713, 24 mg<br> <br> |
| Placebo Comparator: Placebo<br>placebo administered daily | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gravimetric measurement of sweat production | Change from baseline in mean (bilateral average) sweat weight at Week 6 (LOCF) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperhidrosis Disease Severity Scale (HDSS) scores | Percentage of subjects with a change from baseline in HDSS scores of at least -2 points at Week 6 (LOCF) | 6 weeks | 
| Dermatology Life Quality Index (DLQI) scores | Change from baseline in DLQI total score at Week 6 (LOCF) | 6 weeks | 
| Global Assessment of Disease State responses | Global Assessment of Disease State score at Week 6 (LOCF) | 6 weeks |