A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of glycopyrrolate compared to vehicle for the treatment of axillary hyperhidrosis.

Detailed Description
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This is a randomized, vehicle controlled, dose-ranging study enrolling subjects with axillary hyperhidrosis and designed to assess the safety and efficacy of four doses of glycopyrrolate compared to vehicle. There are 5 arms in this study. Efficacy will be assessed through the Hyperhidrosis Disease Severity Score (HDSS), Dermatology Life Quality Index (DLQI) and a gravimetric assessment of sweat production. Safety will be assessed, at specified times during the study, through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs. PK samples will be taken from 20 to 30 subjects participating in the study.

Official Title
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A Phase 2, Randomized, Double-Blind, Vehicle Controlled, Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis

Conditions
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Hyperhidrosis

Intervention / Treatment
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* Drug: glycopyrrolate, 1.0%
* Drug: glycopyrrolate, 2.0%
* Drug: glycopyrrolate, 3.0%
* Drug: glycopyrrolate, 4.0%
* Other: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 18 years of age or older. Primary, axillary hyperhidrosis of at least 6 months duration. A Hyperhidrosis Disease Severity Score (HDSS) of 3or 4. A gravimetric measurement of sweat production of at least 50 mg over 5 minutes in each axilla (total of 100 mg) while at rest at room temperature. Male or non-pregnant, non-lactating females. Exclusion Criteria: Prior surgical procedure for hyperhidrosis. Any prior treatment with an axillary anti-hyperhidrosis medical device (approved or investigational) Prior treatment with botulinum toxin for axillary hyperhidrosis within 1 year. Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis. Treatment with psychotherapeutic medications for less than 4 months prior to study enrollment. - Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks prior to enrollment. Prior axillary treatment with axillary iontophoresis within 4 weeks. Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment. Known history of a condition that may cause secondary hyperhidrosis. Known history of Sjögren's syndrome or Sicca syndrome. Abnormal findings on screening ECG deemed clinically significant by the Investigator.

Ages Eligible for Study
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Minimum Age: 18 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: glycopyrrolate, 1.0%<br>glycopyrrolate Topical Wipes, 1.0% | Drug: glycopyrrolate, 1.0%<br>* glycopyrrolate Topical Wipes, 1.0%<br>* Other names: DRM04B;|
| Experimental: glycopyrrolate, 2.0%<br>glycopyrrolate Topical Wipes, 2.0% | Drug: glycopyrrolate, 2.0%<br>* glycopyrrolate Topical Wipes, 2.0%<br>* Other names: DRM04B;|
| Experimental: glycopyrrolate, 3.0%<br>glycopyrrolate Topical Wipes, 3.0% | Drug: glycopyrrolate, 3.0%<br>* glycopyrrolate Topical Wipes, 3.0%<br>* Other names: DRM04B;|
| Experimental: glycopyrrolate, 4.0%<br>glycopyrrolate Topical Wipes, 4.0% | Drug: glycopyrrolate, 4.0%<br>* glycopyrrolate Topical Wipes, 4.0%<br>* Other names: DRM04B;|
| Placebo Comparator: Vehicle<br>Vehicle Topical Wipes | Other: Vehicle<br>* Vehicle Topical Wipes<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4 | HDSS is a disease specific diagnostic tool that provides a qualitative measure of the severity of the subjects' condition based on how it affects daily activities. 1 (Best), 2, 3, 4 (Worst) | Baseline - Week 4 | 
| Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 4 | Subjects are acclimated to the environment for 30 minutes. Dry gauze is weighed. The dry gauze is then applied to the subject's axilla with the arm down by the subject's side or on their lap during the 5-minute period of sweat production. The gauze with the sweat is then weighed. The difference between the Weight of the gauze with sweat and the dry gauze is the gravimetric sweat measurement in mg/5min. | Baseline - Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4 |  | Baseline - Week 4 | 
| Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6 |  | Baseline - Week 6 | 
| Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6 |  | Baseline - Week 6 | 
| Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 4 | The DLQI is a ten question questionnaire, used to measure the impact of skin disease on the quality of life of an affected person. The scoring of each question is as follows: Very much (3), A lot (2), A little (1), Not at all (0), Not relevant (0). Is calculated by summing the score of each question resulting in a max of 30 and a min of 0. Higher the score the more Quality of life is impaired. | Baseline - Week 4 |