Clinical trial NCT02553798: Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis
Official title: An Open-label Study Assessing Long-term Safety of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperhidrosis
Lead sponsor: Journey Medical Corporation
Sponsor class: INDUSTRY
First posted: 2015-09-18
Enrollment: 564
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Safety will be assessed through adverse events, blood and urine laboratory tests, physical examination, pulse and blood pressure. Local skin reactions will be assessed including burning/stinging, pruritus, edema, erythema, dryness and scaling.

Eligibility criteria: Inclusion Criteria:

* Completed Day 28 of either the DRM04-HH04 or DRM04-HH05 study with at least 80% treatment compliance
* Male or females

Exclusion Criteria:

* 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

Primary outcomes:
measure: Long-term Safety Assessed Through Adverse Events and Local Skin Reactions
timeFrame: Day 1 - Week 44
Secondary outcomes:
Other outcomes:
measure: Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4
timeFrame: Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET
measure: Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS)
timeFrame: Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 44/ET
timeFrame: Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET
Locations:
city: Mobile
country: United States
facility: Coastal Medical Research Group LLC
state: Alabama
city: Rogers
country: United States
facility: Northwest Arkansas Clinical Trials Center, PLLC
state: Arkansas
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Denver
country: United States
facility: Colorado Medical Research Center, Inc
state: Colorado
city: Boca Raton
country: United States
facility: Skin Care Research, Inc.
state: Florida
city: Boynton Beach
country: United States
facility: Study Protocol, Inc
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: North Miami Beach
country: United States
facility: Tory Sullivan, MD
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of the Southeast
state: Florida
city: Carmel
country: United States
facility: Shideler Clinical Research Center
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: Wichita
country: United States
facility: Prairie Health and Wellness
state: Kansas
city: Rockville
country: United States
facility: Lawrence J. Green M.D., LLC
state: Maryland
city: Edina
country: United States
facility: Zel Skin & Laser Specialist
state: Minnesota
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University Dermatology
state: Missouri
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: New York
country: United States
facility: Schweiger Dermatology Group
state: New York
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc
state: New York
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Charleston
country: United States
facility: Dermatology and Laser Center of Charleston, PA
state: Pennsylvania
city: Goodlettsville
country: United States
facility: Rivergate Dermatology Research Center, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates, Inc
state: Tennessee
city: Austin
country: United States
facility: DermResearch
state: Texas
city: College Station
country: United States
facility: J & S Studies, Inc.
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates, PLLC
state: Texas
city: Houston
country: United States
facility: The University of Texas Dermatology Clinical Research Center
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: Plano
country: United States
facility: ACRC Trials
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center, Inc.
state: Utah
city: West Jordan
country: United States
facility: Jordan Valley Dermatology Center, LLC
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Seattle
country: United States
facility: Dermatology Associates
state: Washington
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Berlin
country: Germany
facility: Klinik für Dermatologie, Venerologie und Allergologie Allergie-Centrum-Charité
city: Dülmen
country: Germany
facility: Pro DERMA im Hautzentrum Dulmen
city: Friedrichshafen
country: Germany
facility: Medical Practice and Derma-Study-Center Friedrichshafen GmbH
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera GmbH
city: Glückstadt
country: Germany
facility: Hautarztpraxis
city: Kiel
country: Germany
facility: Tagesklinik DermaKiel
city: Mahlow
country: Germany
facility: Dermatolosche Gemeinschaftspraxis
city: Schweinfurt
country: Germany
facility: Gemeinschaftspraxis Weber & Cranic
Study officials:
affiliation: Dermira, Inc.
name: Lynne Deans, MT
role: STUDY_DIRECTOR
References:
citation: 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.