Assessment of Safety, Tolerability and Efficacy of 1% GPB... | NCT04159610

Studies
Assessment of Safety, Tolerability and Efficacy of 1% GPB Cream Versus Qbrexza® (Glycopyrronium) Cloth 2.4% Under Maximum-Use Conditions in Subjects with Primary Axillary Hyperhidrosis

NCT04159610

Sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel

Status

Withdrawn

Last Update Posted

Dec 24, 2024Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Primary Axillary Hyperhidrosis

Interventions

WO3970
Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was not pursued for internal reasons

Expanded Access Info

Start Date

Dec 2019Estimated

Primary Completion Date

Oct 2020Estimated

Completion Date

Oct 2020Estimated

First Submitted Date

Sep 9, 2019

First Submission Date that Met QC Criteria

Nov 7, 2019

First Posted Date

Nov 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2024

Last Update Posted Date

Dec 24, 2024Actual

Name	Class
Therapeutics, Inc.	INDUSTRY

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
WO 3970	Experimental	Formulation containing WO 3970 for topical application	Drug: WO3970
Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use	Active Comparator	Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use	Drug: Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use

Interventions

Name	Type	Description	Arm Group Labels	Other Names
WO3970	Drug	Application of cream to each axilla	WO 3970
Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of the Steady State systemic Levels of glycopyrronium		Day-1, Day 1 to Day 13, Day 16

Secondary Outcomes

Measure	Description	Time Frame
Systemic pharmacokinetic profile of glycopyrronium at steady state (Area under the drug concentration time curve (AUC))		Day -1, Day 1 to 13, Day 16
Systemic pharmacokinetic profile of glycopyrronium at steady state (Maximum concentration (Cmax))		Day -1, Day 1 to 13, Day 16

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D013543	Sweat Gland Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
C000629920	glycopyrronium tosylate
D006024	Glycopyrrolate
D013784	Textiles

ID	Term
D000644	Quaternary Ammonium Compounds
D000588	Amines
D009930	Organic Chemicals
D009861	Onium Compounds
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D008420	Manufactured Materials
D013676	Technology, Industry, and Agriculture