Study of Glycopyrronium in Axillary Hyperhydrosis

NCT02530281 | Completed Phase 3 Results

• 2 other identifiers: DRM04-HH042015-002052-27
• Study Type: interventional
• Target: 344
• Locations: 2 countries
• Sites: 31

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.

Conditions

Hyperhidrosis

Outcome Measures

Primary Outcomes (4)

• Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of 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: 1. During the past 24 hours, did you have any underarm sweating? (Yes or No) 2. 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) 3. 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) 4. 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.

  From Baseline to Week 4

• Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4

  From Baseline to Week 4

• Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4, Excluding Centers With Outlier Data

  Baseline - Week 4

Secondary Outcomes (2)

• Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4

  From Baseline to Week 4

• 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

Study Arms (2)

glycopyrronium

EXPERIMENTAL

glycopyrronium Topical Wipes

Drug: glycopyrronium Topical Wipes

Vehicle

PLACEBO COMPARATOR

glycopyrronium Topical Wipes, Vehicle

Other: Vehicle

Interventions

glycopyrronium Topical Wipes DRUG

Topical wipes containing glycopyrronium

Also known as: DRM04

glycopyrronium

Vehicle OTHER

Vehicle (placebo) topical wipes

Vehicle

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Journey Medical Corporation: lead

Study Sites (31)

Coastal Clinical Research, Inc.

Mobile, Alabama, 36608, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Skin Care Research, Inc.

Boca Raton, Florida, 33486, United States

Location

Study Protocol, Inc.

Boynton Beach, Florida, 33437, United States

Location

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

Tory Sullivan, M.D., P.A.

North Miami Beach, Florida, 33162, United States

Location

Research Institute of the Southeast

West Palm Beach, Florida, 33401, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Prairie Health and Wellness

Wichita, Kansas, 67226, United States

Location

St. Louis University Dermatology

St Louis, Missouri, 63122, United States

Location

Meridian Clinical Research

Omaha, Nebraska, 68134, United States

Location

Dermatology and Laser Center

Charleston, South Carolina, 29414, United States

Location

Rivergate Dermatology Clinical Research Center, PLLC

Goodlettsville, Tennessee, 37072, United States

Location

DermResearch

Austin, Texas, 78759, United States

Location

J&S Studies

College Station, Texas, 77845, United States

Location

Austin Institute for Clinical Research

Pflugerville, Texas, 78860, United States

Location

ACRC Trials / Innovative Dermatology

Plano, Texas, 75024, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Charlottesville Dermatology Research Center

Charlottesville, Virginia, 22911, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23507, United States

Location

Klinik fur Dermatologie, Allergologie und Venerologie Allergie-Centrum-Charite

Berlin, 10117, Germany

Location

Pro DERMA im Hautzentrum Dulmen

Dülmen, 48249, Germany

Location

Medical Practice and Derma Study Center Friedrichshafen GmbH

Friedrichshafen, 88045, Germany

Location

SRH Wald-Klinikum Gera GmbH

Gera, 07548, Germany

Location

Hautarztpraxis

Glückstadt, 25348, Germany

Location

Tagesklinik DermaKiel

Kiel, 24148, Germany

Location

Dermatolosche Gemeinschaftspraxis

Mahlow, 15831, Germany

Location

Hautarztpraxis

Pinneberg, 25421, Germany

Location

Gemeinschaftspraxis Weber & Cranic

Schweinfurt, 97421, Germany

Location

Hautarztpraxis

Stuttgart, 70499, Germany

Location

Related Publications (3)

• 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.

  PMID: 32147881 DERIVED

• 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.

  PMID: 31111409 DERIVED

• 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.

  PMID: 30378087 DERIVED

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Eugene A. Bauer, MD, Chief Medical Officer
• Organization: Dermira, Inc.

eugene.bauer@dermira.com

650-421-7202

Study Officials

• Lynne M Deans, MT

  Dermira, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 21, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 25, 2021
• Results First Posted: August 14, 2018

Record last verified: 2021-08

Locations

US (21); DE (10)