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 Axillary Hyperhidrosis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04159610
• Other study ID #: GPBBr-02/2019
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: October 2021
• Source: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Contact: Clarissa Masur, PhD
• Phone: +49 521 8808 319
• Email: clarissa.masur[@]drwolffgroup.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: April 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperhidrosis
• Primary Axillary Hyperhidrosis

Intervention

Drug:
• WO3970
Application of cream to each axilla
• Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use
Qbrexza should be applied to the clean, dry, intact skin, of your underarm areas only

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Dr. August Wolff GmbH & Co. KG Arzneimittel	Therapeutics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of the Steady State systemic Levels of glycopyrronium		Day-1, Day 1 to Day 13, Day 16
Secondary	Systemic pharmacokinetic profile of glycopyrronium at steady state (Area under the drug concentration time curve (AUC))		Day -1, Day 1 to 13, Day 16
Secondary	Systemic pharmacokinetic profile of glycopyrronium at steady state (Maximum concentration (Cmax))		Day -1, Day 1 to 13, Day 16
Secondary	Systemic pharmacokinetic profile of glycopyrronium at steady state (Time to CMax (Tmax))		Day -1, Day 1 to 13, Day 16
Secondary	Systemic pharmacokinetic profile of glycopyrronium at steady state (Elimination half-life (t1/2))		Day -1, Day 1 to 13, Day 16
Secondary	Adverse events (AEs)		Day -1 of study period 1 to Day 16
Secondary	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	Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Secondary	Hematology	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
Secondary	Urinalysis	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
Secondary	BP	mmHg	Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Secondary	Respiratory rate	breaths per minute	Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Secondary	Temperature	°C	Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Secondary	Heart rate	bpm	Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Secondary	12-lead ECG	beats per minute [bpm], PR, QRS, QT, QTc, QTcF, and QTcB interval	Screening, Day 1-13 of study period 1 and period 2
Secondary	Physical examination	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
Secondary	Local tolerability	Dermal Evaluation of erythema, edema and papules	Day -1, Day 1-13, Day 16 of study period 1 and period 2
Secondary	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	Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Secondary	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.	Screening, Day -1, Day 1 to 13, Day 16 of study period 1 and period 2
Secondary	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).	Day -1, Day 1 to 13 of period 1 and period 2