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

December 18, 2024 updated by: Dr. August Wolff GmbH & Co. KG Arzneimittel

A Randomized, Open-Label, Multiple Dose, Two-Period Crossover Study Evaluating Maximum Use 1% GPB Cream Versus Qbrexza® (Glycopyrronium) Cloth 2.4% in Men and Women with Primary Axillary Hyperhidrosis

The aim of this study is to investigate the safety, tolerability and efficacy of 1% GPB Cream compared to Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use under maximum use conditions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: WO 3970
Formulation containing WO 3970 for topical application
Drug: WO3970
Application of cream to each axilla
Active Comparator: Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use
Drug: Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use
Qbrexza should be applied to the clean, dry, intact skin, of your underarm areas only

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Measurement of the Steady State systemic Levels of glycopyrronium
Time Frame: Day-1, Day 1 to Day 13, Day 16
Day-1, Day 1 to Day 13, Day 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Systemic pharmacokinetic profile of glycopyrronium at steady state (Area under the drug concentration time curve (AUC))
Time Frame: Day -1, Day 1 to 13, Day 16
Day -1, Day 1 to 13, Day 16
Systemic pharmacokinetic profile of glycopyrronium at steady state (Maximum concentration (Cmax))
Time Frame: Day -1, Day 1 to 13, Day 16
Day -1, Day 1 to 13, Day 16
Systemic pharmacokinetic profile of glycopyrronium at steady state (Time to CMax (Tmax))
Time Frame: Day -1, Day 1 to 13, Day 16
Day -1, Day 1 to 13, Day 16
Systemic pharmacokinetic profile of glycopyrronium at steady state (Elimination half-life (t1/2))
Time Frame: Day -1, Day 1 to 13, Day 16
Day -1, Day 1 to 13, Day 16
Adverse events (AEs)
Time Frame: Day -1 of study period 1 to Day 16
Day -1 of study period 1 to Day 16
Clinical chemistry
Time Frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Albumin, alkaline phosphatase, ALT, AST, BUN, calcium, chloride, CO2, creatinine, direct bilirubin, GGT, glucose, LDH (lactate dehydrogenase), phosphorus, potassium, sodium, total bilirubin, total cholesterol, total protein, uric acid
Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Hematology
Time Frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Hematocrit, hemoglobin, red blood cell (RBC) count, white blood cell (WBC) count, differentials (neutrophils, eosinophils, basophils, lymphocytes, and monocytes), platelet count, and reticulocytes
Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Urinalysis
Time Frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Color, specific gravity, pH, glucose, ketones, protein, bilirubin, urobilinogen, WBCs, RBCs, and microscopy
Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
BP
Time Frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
mmHg
Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Respiratory rate
Time Frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
breaths per minute
Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Temperature
Time Frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
°C
Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Heart rate
Time Frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
bpm
Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
12-lead ECG
Time Frame: Screening, Day 1-13 of study period 1 and period 2
beats per minute [bpm], PR, QRS, QT, QTc, QTcF, and QTcB interval
Screening, Day 1-13 of study period 1 and period 2
Physical examination
Time Frame: Screening, Day -1, Day 16
General appearance; eyes; ears, nose and throat; head and neck; chest and lungs; cardiovascular; Abdomen; musculoskeletal; lymphatic; dermatological; neurological and extremities
Screening, Day -1, Day 16
Local tolerability
Time Frame: Day -1, Day 1-13, Day 16 of study period 1 and period 2
Dermal Evaluation of erythema, edema and papules
Day -1, Day 1-13, Day 16 of study period 1 and period 2
Sweat production by gravimetric measurement
Time Frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
5-minute measurement [filter paper] interval first without then repeated with an immediately preceded subject consumption of 250 mL of hot water swallowed within 1 minute
Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Hyperhidrosis Disease Severity Scale (HDSS)
Time Frame: Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
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.
Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Hyperhidrosis Quality of Life Questionnaire (HydroQoL)
Time Frame: Day -1, Day 1 to 13 of period 1 and period 2
Hyperhidrosis Quality of Life Questionnaire (HydroQoL) is an 18-item, validated, Patient reported Outcome Hyperhidrosis Quality of life Instrument. It is devided into 2 Domains: A Daily Life Activities Domain (6 items) and a Psychosocial Domain (12 items). The items are scored on a 3-point scale (0=no, not at all, 1=a Little, 2=very much).
Day -1, Day 1 to 13 of period 1 and period 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr. August Wolff GmbH & Co. KG Arzneimittel

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Prof. Christoph Abels, MD, PhD, Dr. August Wolff GmbH & Co. KG Arzneimittel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2020

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GPBBr-02/2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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