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

Dr. August Wolff GmbH & Co. KG Arzneimittel

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Primary Axillary Hyperhidrosis

Interventions

WO3970DRUG

Application of cream to each axilla

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

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Measurement of the Steady State systemic Levels of glycopyrronium

Time frame: Day-1, Day 1 to Day 13, Day 16

Secondary Outcomes

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

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

Time frame: 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

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

Time frame: Day -1, Day 1 to 13, Day 16

Adverse events (AEs)

Time frame: Day -1 of study period 1 to Day 16

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

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

Hematology

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

Data from ClinicalTrials.gov

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