Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis

A Phase 3, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis

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.

Study Overview

• Status: Completed
• Conditions: Hyperhidrosis
• Intervention / Treatment: Drug: glycopyrronium Topical Wipes; Other: Vehicle

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.

• Study Type: Interventional
• Enrollment (Actual): 353
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Rogers, Arkansas, United States, 72758
      • Northwest Arkansas Clinical Trials Center, PLLC
  • California
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
  • Colorado
    • Denver, Colorado, United States, 80210
      • Colorado Medical Research Center, Inc.
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Shideler Clinical Research Center
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Lawrence J Green, MD LLC
  • Minnesota
    • Edina, Minnesota, United States, 55424
      • Zel Skin & Laser Specialist
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Medisearch Clinical Trials
  • Nevada
    • Henderson, Nevada, United States, 89044
      • Clinical Studies Group, LLC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Academic Dermatology Associates
  • New York
    • New York, New York, United States, 10022
      • Schweiger Dermatology Group
    • Rochester, New York, United States, 14623
      • Skin Search of Rochester, Inc.
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates, Inc.
  • Texas
    • Dallas, Texas, United States, 75231
      • Modern Research Associates
    • Houston, Texas, United States, 77030
      • The University of Texas Dermatology Clinical Research Center
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Dermatology Research Center, Inc.
    • West Jordan, Utah, United States, 84088
      • Jordan Valley Dermatology Center
  • Washington
    • Seattle, Washington, United States, 98101
      • Dermatology Associates
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: glycopyrronium; glycopyrronium Topical Wipes	Drug: glycopyrronium Topical Wipes; Topical wipes containing glycopyrronium; Other Names: DRM04
PLACEBO_COMPARATOR: Vehicle; glycopyrronium Topical Wipes, Vehicle	Other: Vehicle; Vehicle (placebo) topical wipes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4		From Baseline to Week 4
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	The Axillary Sweating Daily Diary (ASDD) is a 4-item instrument designed to measure the severity of axillary hyperhidrosis and its impact on daily activities. The 4 Items are: During the past 24 hours, did you have any underarm sweating? (Yes or No); During the past 24 hours, how would you rate your underarm sweating at its worst? (0=No sweating at all, 1, 2,…, 10=Worst possible sweating); During the past 24 hours, to what extent did your underarm sweating impact your activities? (0=Not at all, 1=A little bit, 2=A moderate amount, 3=A great deal and 4=An extreme amount); During the past 24 hours, how bothered were you by your underarm sweating? (0=Not at all bothered, 1=A little bothered, 2=Moderately bothered, 3=Very bothered, 4=Extremely bothered)	From Baseline to Week 4
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4	Subjects are acclimated to the environment for 30 minutes. Dry gauze is weighed. The dry gauze is then applied to the subject's axilla with the arm down by the subject's side or on their lap during the 5-minute period of sweat production. The gauze with the sweat is then weighed. The difference between the Weight of the gauze with sweat and the dry gauze is the gravimetric sweat measurement in mg/5min.	Baseline - Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4		From Baseline to Week 4
Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4	Hyperhidrosis Disease Severity Scale (HDSS) is a disease specific diagnostic tool that provides a qualitative measure of the severity of the subjects' condition based on how it affects daily activities.	From Baseline to Week 4

Collaborators and Investigators

• Sponsor: Journey Medical Corporation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (ACTUAL): April 1, 2016
• Study Completion (ACTUAL): April 1, 2016

Study Registration Dates

• First Submitted: August 19, 2015
• First Submitted That Met QC Criteria: August 20, 2015
• First Posted (ESTIMATE): August 21, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Glycopyrrolate
• Other Study ID Numbers: DRM04-HH05; 2015-002053-35 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED