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.

• ClinicalTrials.gov Identifier: NCT03658616
• Recruitment Status: Completed
• First Posted: September 5, 2018
• Last Update Posted: December 23, 2021
• Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Information provided by (Responsible Party): Dr. August Wolff GmbH & Co. KG Arzneimittel

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
Primary Axillary Hyperhidrosis	Drug: WO3970; Drug: Placebo (WO3988)	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 517 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: September 18, 2018
• Actual Primary Completion Date: November 2, 2021
• Actual Study Completion Date: November 2, 2021

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 :

1. 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. [ Time Frame: Baseline (Day 1a), Day 29 ]
2. Long-term part (only for newly recruited patients): Absolute change in sweat production assessed by GM from Baseline (Day 1b) to Week 12 [ Time Frame: Baseline (Day 1b), Week 12 ]

Secondary Outcome Measures :

1. 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 [ Time Frame: 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.
2. 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 [ Time Frame: Day 29 ]
3. Long-term part: Percentage of responders assessed by the HDSS (≥2-point improvement from Baseline) at Week 12 [ Time Frame: Week 12 ]
4. 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 [ Time Frame: Week 4, Week 12 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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
• 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;

Contacts and Locations

Locations

Germany

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

More Information

• Responsible Party: Dr. August Wolff GmbH & Co. KG Arzneimittel
• ClinicalTrials.gov Identifier: NCT03658616
• Other Study ID Numbers: Hyp1-18/2016
• First Posted: September 5, 2018
• Last Update Posted: December 23, 2021
• Last Verified: December 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. August Wolff GmbH & Co. KG Arzneimittel:

Excessive sweating

Additional relevant MeSH terms:

Hyperhidrosis; Sweat Gland Diseases; Skin Diseases