Assessment of Efficacy and Safety of Topical Administration of 1% Glycopyrronium Bromide (GPB) in Patients With Primary Axillary Hyperhidrosis and the Assessment of Long-term Efficacy and Safety of Topical Administration of 1% GPB Cream in Patients With Primary Axillary Hyperhidrosis.

Study Overview
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Brief Summary
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The aim of this study is to investigate the efficacy and safety of 1% GPB cream after 4 weeks of treatment compared with placebo with a sufficient number of patients to obtain statistically significant results, and to assess the long-term safety of 1% GPB cream.

Official Title
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Combined Randomized, Double-blind, Dose-confirming Phase 3a Study in Parallel Design to Assess the Efficacy and Safety of Topical 4-week Treatment With 1% GPB Cream vs Placebo and Open-label Phase 3b Study to Assess Long-term Efficacy and Safety in Patients With Primary Axillary Hyperhidrosis Treated With 1% GPB Cream

Conditions
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Primary Axillary Hyperhidrosis

Intervention / Treatment
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* Drug: WO3970
* Drug: Placebo (WO3988)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of severe primary axillary hyperhidrosis with a HDSS score of 3 or 4 At least 50 mg of sweat production in each axilla measured gravimetrically at room temperature and at a humidity consistent with the normal climate in that area over a period of 5 minutes (patients should have acclimatized to that room for at least 30 minutes) Men and women aged 18 to 65 years at the time of informed consent with a body mass index of 18-32 kg/m2 Able to comply with protocol requirements, including overnight stays, blood sample collections as defined in the protocol subjects Willing and able to provide written informed consent Exclusion Criteria: Known allergy to any of the components in the investigational product. Hypersensitivity against glycopyrrolate Secondary hyperhidrosis, for example, hyperhidrosis that is secondary to other underlying diseases including hyperthyroidism, lymphoma and malaria, climacteric hyperhidrosis. Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage and ultrasonic surgery. Botulinum toxin treatment in the prior 4 months. Angle closure glaucoma or its precipitation (narrow angle). Mycotic, other skin infections and other dermal disorder including infection at anticipated application sites in either axilla. Any condition or situation that, in the investigator's or sub-investigator's opinion, may interfere with the patient's participation 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: WO3970<br>Formulation containing WO3979 for topical application | Drug: WO3970<br>* Application of cream to each axilla<br>|
| Placebo Comparator: Placebo of WO3988<br>Formulation containing Placebo of WO3988 for topical application | Drug: Placebo (WO3988)<br>* Application of cream to each axilla<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-confirming part: Absolute change in sweat production assessed by gravimetric measurement (GM) from Baseline (Day 1a) to Day 29 in the 1% GPB group compared with the placebo group. |  | Baseline (Day 1a), Day 29 | 
| Long-term part (only for newly recruited patients): Absolute change in sweat production assessed by GM from Baseline (Day 1b) to Week 12 |  | Baseline (Day 1b), Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-confirming part: Percentage of responders assessed by the Hyperhidrosis Disease Severity Scale (HDSS) (≥2-point improvement from Baseline) on Day 29 in the 1% GPB group compared with the placebo group | The Hyperhidrosis Disease Severity Scale (HDSS) is a disease-specific, quick, and easily-understood diagnostic tool that provides a qualitative measure of the severity of the patient's condition based on how it affects daily activities. HDSS is a four item scale. A score of 1 or 2 indicates mild or moderate Hyperhidrosis. A score of 3 or 4 indicates severe Hyperhidrosis. | Day 29 | 
| Dose-confirming part: Percentage of responders assessed by GM at Day 29 (defined by sweat reduction of ≥50%, ≥75%, and ≥90% compared with Baseline) in the 1% GPB group compared with the placebo group |  | Day 29 | 
| Long-term part: Percentage of responders assessed by the HDSS (≥2-point improvement from Baseline) at Week 12 |  | Week 12 | 
| Long-term part: Percentage of responders assessed by GM at Week 4 and Week 12 (defined by sweat reduction of ≥50%, ≥75%, and ≥90% compared with Baseline |  | Week 4, Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Excessive sweating