Clinical trial NCT02530281: Study of Glycopyrronium in Axillary Hyperhydrosis
Official title: A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Efficacy and Safety Study of Glycopyrronium in Subjects With Axillary Hyperhydrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperhidrosis
Lead sponsor: Journey Medical Corporation
Sponsor class: INDUSTRY
First posted: 2015-08-21
Enrollment: 344
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a randomized, double-blind, vehicle controlled, parallel group study, designed to assess the efficacy and safety of glycopyrronium topical wipes, once daily, compared to vehicle in subjects with axillary hyperhidrosis.

Detailed description: This is a randomized, double-blind vehicle controlled study to assess the efficacy and safety of glycopyrronium topical wipes compared to vehicle in subjects with axillary hyperhidrosis.

Safety will be assessed through lab tests, ECG, physical exams and vital signs.

Eligibility criteria: Inclusion Criteria:

* Male or female ≥ 9 years of age.
* 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 surgical procedure for hyperhidrosis.
* 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.

Primary outcomes:
measure: Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of ASDD Item #2 From Baseline at Week 4
timeFrame: From Baseline to Week 4
measure: Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4
timeFrame: From Baseline to Week 4
measure: Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4
timeFrame: From Baseline to Week 4
measure: Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4, Excluding Centers With Outlier Data
timeFrame: Baseline - Week 4
Secondary outcomes:
measure: Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4
timeFrame: From Baseline to Week 4
measure: Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4
timeFrame: From Baseline to Week 4
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
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, M.D., P.A.
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of the Southeast
state: Florida
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Wichita
country: United States
facility: Prairie Health and Wellness
state: Kansas
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: Charleston
country: United States
facility: Dermatology and Laser Center
state: South Carolina
city: Goodlettsville
country: United States
facility: Rivergate Dermatology Clinical Research Center, PLLC
state: Tennessee
city: Austin
country: United States
facility: DermResearch
state: Texas
city: College Station
country: United States
facility: J&S Studies
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: Plano
country: United States
facility: ACRC Trials / Innovative Dermatology
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Dermatology Research Center
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Berlin
country: Germany
facility: Klinik fur Dermatologie, Allergologie und Venerologie Allergie-Centrum-Charite
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: Pinneberg
country: Germany
facility: Hautarztpraxis
city: Schweinfurt
country: Germany
facility: Gemeinschaftspraxis Weber & Cranic
city: Stuttgart
country: Germany
facility: Hautarztpraxis
Study officials:
affiliation: Dermira, Inc.
name: Lynne M Deans, MT
role: STUDY_DIRECTOR
References:
citation: 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.
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.
citation: 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.