A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis
NCT ID: NCT02016885
Last Updated: 2021-08-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
198 participants
INTERVENTIONAL
2013-11-30
2014-09-30
Brief Summary
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Detailed Description
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Efficacy will be assessed through the Hyperhidrosis Disease Severity Score (HDSS), Dermatology Life Quality Index (DLQI) and a gravimetric assessment of sweat production.
Safety will be assessed, at specified times during the study, through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs.
PK samples will be taken from 20 to 30 subjects participating in the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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glycopyrrolate, 1.0%
glycopyrrolate Topical Wipes, 1.0%
glycopyrrolate, 1.0%
glycopyrrolate Topical Wipes, 1.0%
glycopyrrolate, 2.0%
glycopyrrolate Topical Wipes, 2.0%
glycopyrrolate, 2.0%
glycopyrrolate Topical Wipes, 2.0%
glycopyrrolate, 3.0%
glycopyrrolate Topical Wipes, 3.0%
glycopyrrolate, 3.0%
glycopyrrolate Topical Wipes, 3.0%
glycopyrrolate, 4.0%
glycopyrrolate Topical Wipes, 4.0%
glycopyrrolate, 4.0%
glycopyrrolate Topical Wipes, 4.0%
Vehicle
Vehicle Topical Wipes
Vehicle
Vehicle Topical Wipes
Interventions
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glycopyrrolate, 1.0%
glycopyrrolate Topical Wipes, 1.0%
glycopyrrolate, 2.0%
glycopyrrolate Topical Wipes, 2.0%
glycopyrrolate, 3.0%
glycopyrrolate Topical Wipes, 3.0%
glycopyrrolate, 4.0%
glycopyrrolate Topical Wipes, 4.0%
Vehicle
Vehicle Topical Wipes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Primary, axillary hyperhidrosis of at least 6 months duration.
* A Hyperhidrosis Disease Severity Score (HDSS) of 3or 4.
* A gravimetric measurement of sweat production of at least 50 mg over 5 minutes in each axilla (total of 100 mg) while at rest at room temperature.
* Male or non-pregnant, non-lactating females.
Exclusion Criteria
* Any prior treatment with an axillary anti-hyperhidrosis medical device (approved or investigational)
* Prior treatment with botulinum toxin for axillary hyperhidrosis within 1 year.
* Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis. Treatment with psychotherapeutic medications for less than 4 months prior to study enrollment. - Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks prior to enrollment.
* Prior axillary treatment with axillary iontophoresis within 4 weeks.
* Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.
* Known history of a condition that may cause secondary hyperhidrosis.
* Known history of Sjögren's syndrome or Sicca syndrome.
* Abnormal findings on screening ECG deemed clinically significant by the Investigator.
18 Years
ALL
No
Sponsors
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Journey Medical Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Lynne M Deans, MT
Role: STUDY_DIRECTOR
Dermira, Inc.
Locations
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Skin Specialists, PC
Omaha, Nebraska, United States
Saint Louis University Dermatology
St Louis, Missouri, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Gary M. Petrus, MD, PA
Little Rock, Arkansas, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Center For Dermatology Clinical Research
Fremont, California, United States
Florida Academic Dermatology Center
Miami, Florida, United States
Kenneth R. Beer, MD, PA
West Palm Beach, Florida, United States
Shideler Clinical Research Center
Carmel, Indiana, United States
Cypress Medical Research Center, LLC
Wichita, Kansas, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
The Dermatology Group, PC
Verona, New Jersey, United States
Oregon Medical Research Center
Portland, Oregon, United States
J&S Studies, Inc.
College Station, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Westend Dermatology Associates
Richmond, Virginia, United States
Dermatology Associates
Seattle, Washington, United States
Women's Clinical Research Center
Seattle, Washington, United States
Premier Clinical Research
Spokane, Washington, United States
Countries
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References
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Pariser DM, Lain EL, Mamelok RD, Drew J, Mould DR. Limited Systemic Exposure with Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis. Clin Pharmacokinet. 2021 May;60(5):665-676. doi: 10.1007/s40262-020-00975-y. Epub 2021 Jan 12.
Other Identifiers
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DRM04-HH01
Identifier Type: -
Identifier Source: org_study_id
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