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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 Purpose

Primary Axillary Hyperhidrosis

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

WO3970

Placebo (WO3988)

About this trial

This is an interventional treatment trial for Primary Axillary Hyperhidrosis focused on measuring Excessive sweating

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

Dr. Harald Brüning

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

WO3970

Placebo of WO3988

Arm Description

Formulation containing WO3979 for topical application

Formulation containing Placebo of WO3988 for topical application

Outcomes

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.

Long-term part (only for newly recruited patients): Absolute change in sweat production assessed by GM from Baseline (Day 1b) to 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

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

Long-term part: Percentage of responders assessed by the HDSS (≥2-point improvement from Baseline) at 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

Full Information

NCT ID

NCT03658616

First Posted

September 3, 2018

Last Updated

April 27, 2023

Sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel

1. Study Identification

Unique Protocol Identification Number

NCT03658616

Brief Title

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.

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

September 18, 2018 (Actual)

Primary Completion Date

November 2, 2021 (Actual)

Study Completion Date

February 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Axillary Hyperhidrosis

Keywords

Excessive sweating

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

518 (Actual)

8. Arms, Groups, and Interventions

Arm Title

WO3970

Arm Type

Experimental

Arm Description

Formulation containing WO3979 for topical application

Arm Title

Placebo of WO3988

Arm Type

Placebo Comparator

Arm Description

Formulation containing Placebo of WO3988 for topical application

Intervention Type

Drug

Intervention Name(s)

WO3970

Intervention Description

Application of cream to each axilla

Intervention Type

Drug

Intervention Name(s)

Placebo (WO3988)

Intervention Description

Application of cream to each axilla

Primary Outcome Measure Information:

Title

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

Title

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 Measure Information:

Title

Description

Time Frame

Day 29

Title

Time Frame

Day 29

Title

Long-term part: Percentage of responders assessed by the HDSS (≥2-point improvement from Baseline) at Week 12

Time Frame

Week 12

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prof. Rolf-Markus Szeimies, MD

Organizational Affiliation

Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dr. Harald Brüning

City

Kiel

ZIP/Postal Code

24148

Country

Germany

12. IPD Sharing Statement

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