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.

Primary Axillary Hyperhidrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03658616
• Other study ID #: Hyp1-18/2016
• Status: Completed
• Phase: Phase 3
• Start date: September 18, 2018
• Est. completion date: February 2, 2022

Study information

• Verified date: April 2023
• Source: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 518
• Est. completion date: February 2, 2022
• Est. primary completion date: November 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Hyperhidrosis
• Primary Axillary Hyperhidrosis

Intervention

Drug:
• WO3970
Application of cream to each axilla
• Placebo (WO3988)
Application of cream to each axilla

Locations

Country	Name	City	State
Germany	Dr. Harald Brüning	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
Dr. August Wolff GmbH & Co. KG Arzneimittel

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Long-term part: Percentage of responders assessed by the HDSS (=2-point improvement from Baseline) at Week 12		Week 12
Secondary	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