Investigation of Ascending Concentrations of Glycopyrronium Bromide (GPB) in a Topical Formulation in Subjects With Axillary Hyperhidrosis

Study Overview
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Brief Summary
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The aim of the study is to assess the safety, tolerability, pharmacokinetics (PK) and efficacy of escalating concentrations of GPB in subjects with axillary hyperhidrosis.

Official Title
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Pharmacokinetics, Local and Systemic Tolerability and Local Efficacy of Ascending Concentrations of Glycopyrronium Bromide (GPB) in a Topical Formulation in a Placebo Controlled, Double Blind Study in Subjects With Axillary Hyperhidrosis

Conditions
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Primary Axillary Hyperhidrosis

Intervention / Treatment
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* Drug: WO3979
* Drug: WO3970
* Drug: WO3992
* Drug: Placebo (WO3988)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of moderate to severe primary axillary hyperhidrosis whose HDSS score is 2, 3 or 4 At least 50 mg in males or 25 mg in females of spontaneous resting axillary sweat production in one axilla measured gravimetrically at room temperature/humidity (about 25°C / 20-50%) over a period of 5 minutes. Male and female subjects in the age of 18 to 65 years at the time of informed consent and a body mass index (BMI) of 18-32 kg/m2. Corrected QT (QTc) ≤450 msec, or QTc <480 msec in subjects with bundle branch block. 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 9 months. Present or history of neuromuscular disease. 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. Significant cardiac arrhythmia such as tachycardiac atrial fibrillation and very frequent extrasystoles. Subject with diabetes mellitus. Subjects with ileus, gastrointestinal stenosis, pronounced chronic inflammatory bowel disease, toxic megacolon. Subjects with epilepsy. Use of antiperspirants containing aluminium chloride and deodorants, any oral herbal medicine treatments or any other topical treatments for hyperhidrosis within 7 days prior to study treatment.

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: WO3979<br>Formulation containing WO3979 for topical application | Drug: WO3979<br>* Application of cream to each axilla<br>|
| Experimental: WO3970<br>Formulation containing WO3970 for topical application | Drug: WO3970<br>* Application of cream to each axilla<br>|
| Experimental: WO3992<br>Formulation containing WO3992 for topical application | Drug: WO3992<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 |
| --- | --- | --- |
| Tolerability and safety assessed through adverse events and local skin reactions |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gravimetric measurement of sweat production |  | 3 weeks | 
| Dermatology Life Quality Index (DLQI) |  | 3 weeks | 
| Hyperhidrosis Disease Severity Scale (HDSS) |  | 3 weeks | 

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