Assessment of Safety, Tolerability and Efficacy of 1% GPB Cream Versus Qbrexza® (Glycopyrronium) Cloth 2.4% Under Maximum-Use Conditions in Subjects 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 safety, tolerability and efficacy of 1% GPB Cream compared to Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use under maximum use conditions.

Official Title
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A Randomized, Open-Label, Multiple Dose, Two-Period Crossover Study Evaluating Maximum Use 1% GPB Cream Versus Qbrexza® (Glycopyrronium) Cloth 2.4% in Men and Women With Primary Axillary Hyperhidrosis

Conditions
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Primary Axillary Hyperhidrosis

Intervention / Treatment
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* Drug: WO3970
* Drug: Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use


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

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WO 3970<br>Formulation containing WO 3970 for topical application | Drug: WO3970<br>* Application of cream to each axilla<br>|
| Active Comparator: Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use<br>Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use | Drug: Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use<br>* Qbrexza should be applied to the clean, dry, intact skin, of your underarm areas only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the Steady State systemic Levels of glycopyrronium |  | Day-1, Day 1 to Day 13, Day 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic pharmacokinetic profile of glycopyrronium at steady state (Area under the drug concentration time curve (AUC)) |  | Day -1, Day 1 to 13, Day 16 | 
| Systemic pharmacokinetic profile of glycopyrronium at steady state (Maximum concentration (Cmax)) |  | Day -1, Day 1 to 13, Day 16 | 
| Systemic pharmacokinetic profile of glycopyrronium at steady state (Time to CMax (Tmax)) |  | Day -1, Day 1 to 13, Day 16 | 
| Systemic pharmacokinetic profile of glycopyrronium at steady state (Elimination half-life (t1/2)) |  | Day -1, Day 1 to 13, Day 16 | 
| Adverse events (AEs) |  | Day -1 of study period 1 to Day 16 | 
| Clinical chemistry | Albumin, alkaline phosphatase, ALT, AST, BUN, calcium, chloride, CO2, creatinine, direct bilirubin, GGT, glucose, LDH (lactate dehydrogenase), phosphorus, potassium, sodium, total bilirubin, total cholesterol, total protein, uric acid | Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 | 
| Hematology | Hematocrit, hemoglobin, red blood cell (RBC) count, white blood cell (WBC) count, differentials (neutrophils, eosinophils, basophils, lymphocytes, and monocytes), platelet count, and reticulocytes | Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 | 
| Urinalysis | Color, specific gravity, pH, glucose, ketones, protein, bilirubin, urobilinogen, WBCs, RBCs, and microscopy | Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 | 
| BP | mmHg | Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 | 
| Respiratory rate | breaths per minute | Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 | 
| Temperature | °C | Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 | 
| Heart rate | bpm | Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 | 
| 12-lead ECG | beats per minute [bpm], PR, QRS, QT, QTc, QTcF, and QTcB interval | Screening, Day 1-13 of study period 1 and period 2 | 
| Physical examination | General appearance; eyes; ears, nose and throat; head and neck; chest and lungs; cardiovascular; Abdomen; musculoskeletal; lymphatic; dermatological; neurological and extremities | Screening, Day -1, Day 16 | 
| Local tolerability | Dermal Evaluation of erythema, edema and papules | Day -1, Day 1-13, Day 16 of study period 1 and period 2 | 
| Sweat production by gravimetric measurement | 5-minute measurement [filter paper] interval first without then repeated with an immediately preceded subject consumption of 250 mL of hot water swallowed within 1 minute | Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 | 
| Hyperhidrosis Disease Severity Scale (HDSS) | 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. | Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2 | 
| Hyperhidrosis Quality of Life Questionnaire (HydroQoL) | Hyperhidrosis Quality of Life Questionnaire (HydroQoL) is an 18-item, validated, Patient reported Outcome Hyperhidrosis Quality of life Instrument. It is devided into 2 Domains: A Daily Life Activities Domain (6 items) and a Psychosocial Domain (12 items). The items are scored on a 3-point scale (0=no, not at all, 1=a Little, 2=very much). | Day -1, Day 1 to 13 of period 1 and period 2 | 

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