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

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.

Study Overview

• Status: Completed
• Conditions: Hyperhidrosis
• Intervention / Treatment: Drug: Glycopyrronium Topical Wipes

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.

• Study Type: Interventional
• Enrollment (Actual): 564
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Klinik für Dermatologie, Venerologie und Allergologie Allergie-Centrum-Charité
  • Dülmen, Germany, 48249
    • Pro DERMA im Hautzentrum Dulmen
  • Friedrichshafen, Germany, 88045
    • Medical Practice and Derma-Study-Center Friedrichshafen GmbH
  • Gera, Germany, 07548
    • SRH Wald-Klinikum Gera GmbH
  • Glückstadt, Germany, 25348
    • Hautarztpraxis
  • Kiel, Germany, 24148
    • Tagesklinik DermaKiel
  • Mahlow, Germany, 15831
    • Dermatolosche Gemeinschaftspraxis
  • Schweinfurt, Germany, 97421
    • Gemeinschaftspraxis Weber & Cranic
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Coastal Medical Research Group LLC
  • Arkansas
    • Rogers, Arkansas, United States, 72758
      • Northwest Arkansas Clinical Trials Center, PLLC
  • California
    • Encinitas, California, United States, 92024
      • California Dermatology & Clinical Research Institute
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
  • Colorado
    • Denver, Colorado, United States, 80210
      • Colorado Medical Research Center, Inc
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Skin Care Research, Inc.
    • Boynton Beach, Florida, United States, 33437
      • Study Protocol, Inc
    • Miami, Florida, United States, 33144
      • International Dermatology Research, Inc.
    • North Miami Beach, Florida, United States, 33162
      • Tory Sullivan, MD
    • West Palm Beach, Florida, United States, 33401
      • Research Institute of the Southeast
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Shideler Clinical Research Center
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center, PC
  • Kansas
    • Wichita, Kansas, United States, 67206
      • Prairie Health and Wellness
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Lawrence J. Green M.D., LLC
  • Minnesota
    • Edina, Minnesota, United States, 55424
      • Zel Skin & Laser Specialist
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Medisearch Clinical Trials
    • Saint Louis, Missouri, United States, 63122
      • St. Louis University Dermatology
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106-5239
      • 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
  • Pennsylvania
    • Charleston, Pennsylvania, United States, 29414
      • Dermatology and Laser Center of Charleston, PA
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • Rivergate Dermatology Research Center, PLLC
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates, Inc
  • Texas
    • Austin, Texas, United States, 78759
      • DermResearch
    • College Station, Texas, United States, 77845
      • J & S Studies, Inc.
    • Dallas, Texas, United States, 75231
      • Modern Research Associates, PLLC
    • Houston, Texas, United States, 77030
      • The University of Texas Dermatology Clinical Research Center
    • Pflugerville, Texas, United States, 78860
      • Austin Institute for Clinical Research
    • Plano, Texas, United States, 75024
      • ACRC Trials
    • San Antonio, Texas, United States, 78218
      • Texas Dermatology and Laser Specialists
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Dermatology Research Center, Inc.
    • West Jordan, Utah, United States, 84088
      • Jordan Valley Dermatology Center, LLC
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research, Inc.
  • 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 (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glycopyrronium; Glycopyrronium Topical Wipes	Drug: Glycopyrronium Topical Wipes; Glycopyrronium Topical Wipes; Other Names: DRM04

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET
Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS)	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.	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	The Dermatology Life Quality Index DLQI is a ten question questionnaire, used to measure the impact of skin disease on the quality of life of an affected person. The scoring of each question is as follows: Very much (3), A lot (2), A little (1), Not at all (0), Not relevant (0). Is calculated by summing the score of each question resulting in a max of 30 and a min of 0. Higher the score the more Quality of life is impaired.	Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET

Collaborators and Investigators

• Sponsor: Journey Medical Corporation
• Investigators: Study Director: Lynne Deans, MT, Dermira, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: September 15, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimate): September 18, 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-HH06