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.

Phase 3

Completed

• Conditions: Primary Axillary Hyperhidrosis
• Interventions: Drug: WO3970; Drug: Placebo (WO3988)

• Registration Number: NCT03658616
• Lead Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-03
• Study First Submitted QC: 2018-09-03
• Study First Posted: 2018-09-05
• Study Start: 2018-09-18
• Primary Completion: 2021-11-02
• Study Completion: 2022-02-02
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 518

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WO3970	WO3970	Formulation containing WO3979 for topical application
Placebo of WO3988	Placebo (WO3988)	Formulation containing Placebo of WO3988 for topical application

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dr. Harald Brüning; 🇩🇪 Kiel, Germany