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
NCT ID: NCT04159610
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2019-12-31
2020-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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WO 3970
Formulation containing WO 3970 for topical application
WO3970
Application of cream to each axilla
Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use
Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use
Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use
Qbrexza should be applied to the clean, dry, intact skin, of your underarm areas only
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Therapeutics, Inc.
INDUSTRY
Dr. August Wolff GmbH & Co. KG Arzneimittel
INDUSTRY
Responsible Party
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Other Identifiers
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GPBBr-02/2019
Identifier Type: -
Identifier Source: org_study_id