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 Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: WO3970 Formulation containing WO3979 for topical application |
Drug: WO3970
Application of cream to each axilla
|
| Placebo Comparator: Placebo of WO3988 Formulation containing Placebo of WO3988 for topical application |
Drug: Placebo (WO3988)
Application of cream to each axilla
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 [Day 29]
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.
- 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]
Eligibility Criteria
Criteria
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
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Willing and able to provide written informed consent
Exclusion Criteria:
-
Known allergy to any of the components in the investigational product.
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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;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dr. Harald Brüning | Kiel | Germany | 24148 |
Sponsors and Collaborators
- Dr. August Wolff GmbH & Co. KG Arzneimittel
Investigators
- Principal Investigator: Prof. Rolf-Markus Szeimies, MD, Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Hyp1-18/2016