Clinical trial NCT02530294: Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis
Official title: A Phase 3, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperhidrosis
Lead sponsor: Journey Medical Corporation
Sponsor class: INDUSTRY
First posted: 2015-08-21
Enrollment: 353
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 Axillary Sweating Daily Diary (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: Baseline - Week 4
measure: Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4
timeFrame: From Baseline to 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: Rogers
country: United States
facility: Northwest Arkansas Clinical Trials Center, PLLC
state: Arkansas
city: Los Angeles
country: United States
facility: Dermatology Research Associates
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: Carmel
country: United States
facility: Shideler Clinical Research Center
state: Indiana
city: Rockville
country: United States
facility: Lawrence J Green, MD 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: Henderson
country: United States
facility: Clinical Studies Group, LLC
state: Nevada
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: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: Houston
country: United States
facility: The University of Texas Dermatology Clinical Research Center
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
state: Utah
city: Seattle
country: United States
facility: Dermatology Associates
state: Washington
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
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.