Combined Randomized, Double-blind, Dose-confirming Phase 3a Study in Parallel Design to Assess the Efficacy and Safety of Topical 4-week Treatment With 1% GPB Cream vs Placebo and Open-label Phase 3b Study to Assess Long-term Efficacy and Safety in Patients With Primary Axillary Hyperhidrosis Treated With 1% GPB Cream

Hyp1-18/2016

The aim of this study is to investigate the efficacy and safety of 1% GPB cream after 4 weeks of treatment compared with placebo with a sufficient number of patients to obtain statistically significant results, and to assess the long-term safety of 1% GPB cream.

2018-09-18

2021-11-02

2022-02-02

Completed

Early phase I

518

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;

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2023-04-28