Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis
An Open-label Study Assessing Long-term Safety of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis
1 other identifier
interventional
564
2 countries
48
Brief Summary
This is an open-label, long-term safety study of glycopyrronium topical wipes, enrolling up to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04 or DRM04-HH05 studies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2015
Shorter than P25 for phase_3
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 15, 2015
CompletedFirst Posted
Study publicly available on registry
September 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
September 25, 2018
CompletedAugust 25, 2021
August 1, 2021
1.3 years
September 15, 2015
July 20, 2018
August 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Long-term Safety Assessed Through Adverse Events and Local Skin Reactions
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
Day 1 - Week 44
Other Outcomes (3)
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4
Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET
Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS)
Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 44/ET
Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET
Study Arms (1)
Glycopyrronium
EXPERIMENTALGlycopyrronium Topical Wipes
Interventions
Eligibility Criteria
You may qualify if:
- Completed Day 28 of either the DRM04-HH04 or DRM04-HH05 study with at least 80% treatment compliance
- Male or females
You may not qualify if:
- Subject has a clinically significant abnormality on physical exam, vital signs or ECG at the Week 4 visit of DRM04-HH04 or DRM04-HH05 study that would make further treatment with glycopyrronium contraindicated
- Male with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy
- Any other condition which, in the judgement of the Investigator, would put the subject at unacceptable risk for participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Coastal Medical Research Group LLC
Mobile, Alabama, 36608, United States
Northwest Arkansas Clinical Trials Center, PLLC
Rogers, Arkansas, 72758, United States
California Dermatology & Clinical Research Institute
Encinitas, California, 92024, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
Colorado Medical Research Center, Inc
Denver, Colorado, 80210, United States
Skin Care Research, Inc.
Boca Raton, Florida, 33486, United States
Study Protocol, Inc
Boynton Beach, Florida, 33437, United States
International Dermatology Research, Inc.
Miami, Florida, 33144, United States
Tory Sullivan, MD
North Miami Beach, Florida, 33162, United States
Research Institute of the Southeast
West Palm Beach, Florida, 33401, United States
Shideler Clinical Research Center
Carmel, Indiana, 46032, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168, United States
Prairie Health and Wellness
Wichita, Kansas, 67206, United States
Lawrence J. Green M.D., LLC
Rockville, Maryland, 20850, United States
Zel Skin & Laser Specialist
Edina, Minnesota, 55424, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506, United States
St. Louis University Dermatology
St Louis, Missouri, 63122, United States
Meridian Clinical Research
Omaha, Nebraska, 68134, United States
Academic Dermatology Associates
Albuquerque, New Mexico, 87106-5239, United States
Schweiger Dermatology Group
New York, New York, 10022, United States
Skin Search of Rochester, Inc
Rochester, New York, 14623, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
Dermatology and Laser Center of Charleston, PA
Charleston, Pennsylvania, 29414, United States
Rivergate Dermatology Research Center, PLLC
Goodlettsville, Tennessee, 37072, United States
Clinical Research Associates, Inc
Nashville, Tennessee, 37203, United States
DermResearch
Austin, Texas, 78759, United States
J & S Studies, Inc.
College Station, Texas, 77845, United States
Modern Research Associates, PLLC
Dallas, Texas, 75231, United States
The University of Texas Dermatology Clinical Research Center
Houston, Texas, 77030, United States
Austin Institute for Clinical Research
Pflugerville, Texas, 78860, United States
ACRC Trials
Plano, Texas, 75024, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84117, United States
Jordan Valley Dermatology Center, LLC
West Jordan, Utah, 84088, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507, United States
Dermatology Associates
Seattle, Washington, 98101, United States
Premier Clinical Research
Spokane, Washington, 99202, United States
Klinik für Dermatologie, Venerologie und Allergologie Allergie-Centrum-Charité
Berlin, 10117, Germany
Pro DERMA im Hautzentrum Dulmen
Dülmen, 48249, Germany
Medical Practice and Derma-Study-Center Friedrichshafen GmbH
Friedrichshafen, 88045, Germany
SRH Wald-Klinikum Gera GmbH
Gera, 07548, Germany
Hautarztpraxis
Glückstadt, 25348, Germany
Tagesklinik DermaKiel
Kiel, 24148, Germany
Dermatolosche Gemeinschaftspraxis
Mahlow, 15831, Germany
Gemeinschaftspraxis Weber & Cranic
Schweinfurt, 97421, Germany
Related Publications (1)
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.
PMID: 31111409DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eugene A. Bauer, MD, Chief Medical Officer
- Organization
- Dermira, Inc.
Study Officials
- STUDY DIRECTOR
Lynne Deans, MT
Dermira, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2015
First Posted
September 18, 2015
Study Start
August 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
August 25, 2021
Results First Posted
September 25, 2018
Record last verified: 2021-08