Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis

NCT02129660 | Completed Phase 2 Results

• 1 other identifier: DRM04-HH02
• Study Type: interventional
• Target: 105
• Locations: 2 countries
• Sites: 15

Brief Summary

The purpose of the study is to assess the safety of 2 doses of glycopyrrolate compared to 2 doses of glycopyrronium and vehicle (5 treatment arms) for the treatment of axillary hyperhidrosis when applied once daily for 4 weeks followed by a 2-week post-dose period.

Conditions

Hyperhidrosis

Outcome Measures

Primary Outcomes (5)

• Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4

  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. 1 (Best), 2, 3, 4 (Worst)

  Baseline - Week 4/ET

• Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4

  Baseline - Week 4

• Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6

  Baseline - Week 6

• Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to 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

• Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6

  Baseline - Week 6

Secondary Outcomes (2)

• Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4

  Baseline - Week 4

• Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 6

  Baseline - Week 6

Study Arms (5)

Dose 1 of glycopyrrolate, 2.0% QD

EXPERIMENTAL

glycopyrrolate Topical Wipes

Drug: Dose 1 of glycopyrrolate, 2.0% QD

Dose 2 of glycopyrrolate, 3.0% QD

EXPERIMENTAL

glycopyrrolate Topical Wipes

Drug: Dose 2 of glycopyrrolate, 3.0% QD

Dose 1 of glycopyrronium, 2.5% QD

ACTIVE COMPARATOR

glycopyrronium Topical Wipes

Drug: Dose 1 of glycopyrronium, 2.5% QD

Dose 2 of glycopyrronium, 3.75% QD

ACTIVE COMPARATOR

glycopyrronium Topical Wipes

Drug: Dose 2 of glycopyrronium, 3.75% QD

Vehicle

PLACEBO COMPARATOR

Vehicle Topical Wipes

Other: Vehicle

Interventions

Dose 1 of glycopyrrolate, 2.0% QD DRUG

Dose 1 of glycopyrrolate Topical Wipes

Also known as: DRM04B

Dose 1 of glycopyrrolate, 2.0% QD

Dose 2 of glycopyrrolate, 3.0% QD DRUG

Dose 2 of glycopyrrolate Topical Wipes

Also known as: DRM04B

Dose 2 of glycopyrrolate, 3.0% QD

Dose 1 of glycopyrronium, 2.5% QD DRUG

Dose 1 of glycopyrronium Topical Wipes

Also known as: DRM04

Dose 1 of glycopyrronium, 2.5% QD

Dose 2 of glycopyrronium, 3.75% QD DRUG

Dose 2 of glycopyrronium Topical Wipes

Also known as: DRM04

Dose 2 of glycopyrronium, 3.75% QD

Vehicle OTHER

Vehicle Topical Wipes

Vehicle

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years of age or older.
• Primary, axillary hyperhidrosis of at least 6 months duration.
• Hyperhidrosis Disease Severity Score (HDSS) of 3 or 4 at baseline.
• For each axilla, a baseline gravimetric measurement of sweat production of at least 50 mg over 5 minutes, while at rest, at room temperature.
• Male or non-pregnant, non-lactating females.

You may not qualify if:

• Current pregnancy or lactation.
• Prior surgical procedure for hyperhidrosis.
• Any prior axillary treatment with an anti-hyperhidrosis medical device
• Any prior treatment with an investigational drug within 4 weeks prior to Baseline/Day 1 or within 5 elimination half lives of the active agent, whichever is longer or 6 weeks if the elimination half life is not known. Experimental devices are excluded without the approval of the Medical Monitor.
• Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day 1.
• Subjects with clinically significant abnormalities in laboratory values.
• Subjects with a positive Hepatitis or HIV.Hepatitis B surface antibody positive is allowed only if the subject has a history of having received Hepatitis B vaccination and there are no clinically significant abnormalities in screening liver function tests.
• Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis, within one month prior to Baseline/Day 1.
• Treatment with psychotherapeutic medications for less than 4 months prior to Baseline/Day 1.
• Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks of the baseline visit
• Prior treatment with axillary iontophoresis within 4 weeks of Baseline/Day 1.
• Any previous IV or oral treatment with the study drug.
• Prior treatment with the topical study drug in a previous trial.
• Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.
• Presence of a condition, within 10 years of enrollment, that may cause secondary hyperhidrosis

Sponsors & Collaborators

• Journey Medical Corporation: lead

Study Sites (15)

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

Center For Dermatology Clinical Research

Fremont, California, 94538, United States

Location

Olympian Clinical Research

Tampa, Florida, 33609, United States

Location

Kenneth R. Beer MD

West Palm Beach, Florida, 33401, United States

Location

Shideler Clinical Research Center

Carmel, Indiana, 46032, United States

Location

Saint Louis University Dermatology

St Louis, Missouri, 63122, United States

Location

Haber Dermatology and Cosmetic Surgery

Beachwood, Ohio, 44122, United States

Location

Rivergate Dermatology Clinical Research Center, PLLC

Goodlettsville, Tennessee, 37072, United States

Location

DermResearch, Inc

Austin, Texas, 78759, United States

Location

Dermatology Research Center, Inc.

Salt Lake City, Utah, 84117, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23507, United States

Location

Dermatology Associates

Seattle, Washington, 98101, United States

Location

Women's Clinical Research Center

Seattle, Washington, 98105, United States

Location

Premier Clinical Research

Spokane, Washington, 99204, United States

Location

Innovaderm Research Inc.

Montreal, H2K 4L5, Canada

Location

Related Publications (1)

• Pariser DM, Lain EL, Mamelok RD, Drew J, Mould DR. Limited Systemic Exposure with Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis. Clin Pharmacokinet. 2021 May;60(5):665-676. doi: 10.1007/s40262-020-00975-y. Epub 2021 Jan 12.

  PMID: 33433785 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 2
• 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: April 30, 2014
• First Posted: May 2, 2014
• Study Start: April 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: September 17, 2025
• Results First Posted: September 4, 2018

Record last verified: 2025-09

Locations

US (14); CA (1)