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.

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Axillary Hyperhidrosis
• Intervention / Treatment: Drug: WO3970; Drug: Placebo (WO3988)

• Study Type: Interventional
• Enrollment (Actual): 518
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Kiel, Germany, 24148
    • Dr. Harald Brüning

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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	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.	Day 29
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

Collaborators and Investigators

• Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Investigators: Principal Investigator: Prof. Rolf-Markus Szeimies, MD, Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2018
• Primary Completion (Actual): November 2, 2021
• Study Completion (Actual): February 2, 2022

Study Registration Dates

• First Submitted: September 3, 2018
• First Submitted That Met QC Criteria: September 3, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Excessive sweating
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis
• Other Study ID Numbers: Hyp1-18/2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No