Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
344 participants
INTERVENTIONAL
2015-07-31
2016-03-31
Brief Summary
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Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis
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Detailed Description
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Safety will be assessed through lab tests, ECG, physical exams and vital signs.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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glycopyrronium
glycopyrronium Topical Wipes
glycopyrronium Topical Wipes
Topical wipes containing glycopyrronium
Vehicle
glycopyrronium Topical Wipes, Vehicle
Vehicle
Vehicle (placebo) topical wipes
Interventions
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glycopyrronium Topical Wipes
Topical wipes containing glycopyrronium
Vehicle
Vehicle (placebo) 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
* Hyperhidrosis Disease Severity Scale (HDSS) of 3 or 4 at Baseline
* Axillary Sweating Daily Diary (ASDD) ≥ 4 at Baseline
* Sweat production of at least 50 mg over 5 minutes in each axilla assessed gravimetrically
Exclusion Criteria
* Prior axillary treatment with an anti-hyperhidrosis medical device (approved or investigational).
* Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day 1.
* Previous active treatment in the Dermira DRM04-HH01 or DRM04-HH02 clinical trials.
* Axillary use of nonprescription antiperspirants within 1 week or prescription antiperspirants within 2 weeks of Baseline.
* Subjects on new or regimens of psychotherapeutic medications that have changed within 2 months of baseline.
* Treatment with systemic anticholinergics within 4 weeks of the baseline visit unless dosing has been stable for at least 4 months.
* Other treatment with glycopyrrolate within 4 weeks prior to Baseline.
* Secondary axillary hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis.
* History of Sjögren's syndrome or Sicca syndrome.
* History of glaucoma, inflammatory bowel disease, toxic megacolon, or febrile illness.
* Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.
* History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter.
* Other systemic diseases or active uncontrolled infections, or any other condition which, in the judgment of the Investigator, would put the subject at unacceptable risk for participation in the study.
9 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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Coastal Clinical Research, Inc.
Mobile, Alabama, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Therapeutics Clinical Research
San Diego, California, United States
Skin Care Research, Inc.
Boca Raton, Florida, United States
Study Protocol, Inc.
Boynton Beach, Florida, United States
International Dermatology Research, Inc.
Miami, Florida, United States
Tory Sullivan, M.D., P.A.
North Miami Beach, Florida, United States
Research Institute of the Southeast
West Palm Beach, Florida, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Prairie Health and Wellness
Wichita, Kansas, United States
St. Louis University Dermatology
St Louis, Missouri, United States
Meridian Clinical Research
Omaha, Nebraska, United States
Dermatology and Laser Center
Charleston, South Carolina, United States
Rivergate Dermatology Clinical Research Center, PLLC
Goodlettsville, Tennessee, United States
DermResearch
Austin, Texas, United States
J&S Studies
College Station, Texas, United States
Austin Institute for Clinical Research
Pflugerville, Texas, United States
ACRC Trials / Innovative Dermatology
Plano, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Charlottesville Dermatology Research Center
Charlottesville, Virginia, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Klinik fur Dermatologie, Allergologie und Venerologie Allergie-Centrum-Charite
Berlin, , Germany
Pro DERMA im Hautzentrum Dulmen
Dülmen, , Germany
Medical Practice and Derma Study Center Friedrichshafen GmbH
Friedrichshafen, , Germany
SRH Wald-Klinikum Gera GmbH
Gera, , Germany
Hautarztpraxis
Glückstadt, , Germany
Tagesklinik DermaKiel
Kiel, , Germany
Dermatolosche Gemeinschaftspraxis
Mahlow, , Germany
Hautarztpraxis
Pinneberg, , Germany
Gemeinschaftspraxis Weber & Cranic
Schweinfurt, , Germany
Hautarztpraxis
Stuttgart, , Germany
Countries
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References
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Hebert AA, Glaser DA, Green L, Hull C, Cather J, Drew J, Gopalan R, Pariser DM. Long-term efficacy and safety of topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Post hoc pediatric subgroup analysis from a 44-week open-label extension study. Pediatr Dermatol. 2020 May;37(3):490-497. doi: 10.1111/pde.14135. Epub 2020 Mar 8.
Glaser DA, Hebert AA, Nast A, Werschler WP, Green L, Mamelok RD, Quiring J, Drew J, Pariser DM. A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis. Am J Clin Dermatol. 2019 Aug;20(4):593-604. doi: 10.1007/s40257-019-00446-6.
Pariser DM, Hebert AA, Drew J, Quiring J, Gopalan R, Glaser DA. Topical Glycopyrronium Tosylate for the Treatment of Primary Axillary Hyperhidrosis: Patient-Reported Outcomes from the ATMOS-1 and ATMOS-2 Phase III Randomized Controlled Trials. Am J Clin Dermatol. 2019 Feb;20(1):135-145. doi: 10.1007/s40257-018-0395-0.
Other Identifiers
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2015-002052-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DRM04-HH04
Identifier Type: -
Identifier Source: org_study_id
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