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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

Primary Purpose

Primary Axillary Hyperhidrosis

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

WO3970

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

About this trial

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

Eligibility Criteria

18 Years - undefined (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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

WO 3970

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

Arm Description

Formulation containing WO 3970 for topical application

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

Outcomes

Primary Outcome Measures

Measurement of the Steady State systemic Levels of glycopyrronium

Secondary Outcome Measures

Systemic pharmacokinetic profile of glycopyrronium at steady state (Area under the drug concentration time curve (AUC))

Systemic pharmacokinetic profile of glycopyrronium at steady state (Maximum concentration (Cmax))

Systemic pharmacokinetic profile of glycopyrronium at steady state (Time to CMax (Tmax))

Systemic pharmacokinetic profile of glycopyrronium at steady state (Elimination half-life (t1/2))

Adverse events (AEs)

Clinical chemistry

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

Hematology

Hematocrit, hemoglobin, red blood cell (RBC) count, white blood cell (WBC) count, differentials (neutrophils, eosinophils, basophils, lymphocytes, and monocytes), platelet count, and reticulocytes

Urinalysis

Color, specific gravity, pH, glucose, ketones, protein, bilirubin, urobilinogen, WBCs, RBCs, and microscopy

mmHg

Respiratory rate

breaths per minute

Temperature

°C

Heart rate

bpm

12-lead ECG

beats per minute [bpm], PR, QRS, QT, QTc, QTcF, and QTcB interval

Physical examination

General appearance; eyes; ears, nose and throat; head and neck; chest and lungs; cardiovascular; Abdomen; musculoskeletal; lymphatic; dermatological; neurological and extremities

Local tolerability

Dermal Evaluation of erythema, edema and papules

Sweat production by gravimetric measurement

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

Hyperhidrosis Disease Severity Scale (HDSS)

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.

Hyperhidrosis Quality of Life Questionnaire (HydroQoL)

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).

Full Information

NCT ID

NCT04159610

First Posted

September 9, 2019

Last Updated

October 5, 2021

Sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel

Collaborators

Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04159610

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2022 (Anticipated)

Primary Completion Date

February 1, 2023 (Anticipated)

Study Completion Date

April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel

Collaborators

Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

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 safety, tolerability and efficacy of 1% GPB Cream compared to Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use under maximum use conditions.

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 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

WO 3970

Arm Type

Experimental

Arm Description

Formulation containing WO 3970 for topical application

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

WO3970

Intervention Description

Application of cream to each axilla

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

Qbrexza should be applied to the clean, dry, intact skin, of your underarm areas only

Primary Outcome Measure Information:

Title

Measurement of the Steady State systemic Levels of glycopyrronium

Time Frame

Day-1, Day 1 to Day 13, Day 16

Secondary Outcome Measure Information:

Title

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

Title

Systemic pharmacokinetic profile of glycopyrronium at steady state (Maximum concentration (Cmax))

Time Frame

Day -1, Day 1 to 13, Day 16

Title

Systemic pharmacokinetic profile of glycopyrronium at steady state (Time to CMax (Tmax))

Time Frame

Day -1, Day 1 to 13, Day 16

Title

Systemic pharmacokinetic profile of glycopyrronium at steady state (Elimination half-life (t1/2))

Time Frame

Day -1, Day 1 to 13, Day 16

Title

Adverse events (AEs)

Time Frame

Day -1 of study period 1 to Day 16

Title

Clinical chemistry

Description

Time Frame

Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2

Title

Hematology

Description

Hematocrit, hemoglobin, red blood cell (RBC) count, white blood cell (WBC) count, differentials (neutrophils, eosinophils, basophils, lymphocytes, and monocytes), platelet count, and reticulocytes

Time Frame

Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2

Title

Urinalysis

Description

Color, specific gravity, pH, glucose, ketones, protein, bilirubin, urobilinogen, WBCs, RBCs, and microscopy

Time Frame

Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2

Title

Description

mmHg

Time Frame

Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2

Title

Respiratory rate

Description

breaths per minute

Time Frame

Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2

Title

Temperature

Description

°C

Time Frame

Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2

Title

Heart rate

Description

bpm

Time Frame

Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2

Title

12-lead ECG

Description

beats per minute [bpm], PR, QRS, QT, QTc, QTcF, and QTcB interval

Time Frame

Screening, Day 1-13 of study period 1 and period 2

Title

Physical examination

Description

General appearance; eyes; ears, nose and throat; head and neck; chest and lungs; cardiovascular; Abdomen; musculoskeletal; lymphatic; dermatological; neurological and extremities

Time Frame

Screening, Day -1, Day 16

Title

Local tolerability

Description

Dermal Evaluation of erythema, edema and papules

Time Frame

Day -1, Day 1-13, Day 16 of study period 1 and period 2

Title

Sweat production by gravimetric measurement

Description

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

Time Frame

Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2

Title

Hyperhidrosis Disease Severity Scale (HDSS)

Description

Time Frame

Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2

Title

Hyperhidrosis Quality of Life Questionnaire (HydroQoL)

Description

Time Frame

Day -1, Day 1 to 13 of period 1 and period 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Clarissa Masur, PhD

Phone

+49 521 8808 319

clarissa.masur@drwolffgroup.com

First Name & Middle Initial & Last Name or Official Title & Degree

Sören Merker, PhD

Phone

+49 521 8808 597

soeren.merker@drwolffgroup.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prof. Christoph Abels, MD, PhD

Organizational Affiliation

Dr. August Wolff GmbH & Co. KG Arzneimittel

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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