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

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

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • 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 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

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
Intervention / Treatment
Experimental: WO 3970
Formulation containing WO 3970 for topical application
Application of cream to each axilla
Active Comparator: 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

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

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.

Collaborators

Investigators

  • 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 (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

September 9, 2019

First Submitted That Met QC Criteria

November 7, 2019

First Posted (Actual)

November 12, 2019

Study Record Updates

Last Update Posted (Actual)

October 6, 2021

Last Update Submitted That Met QC Criteria

October 5, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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