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

NCT ID: NCT02129660

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-01-31

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.

Detailed Description

This is a randomized, double-blind, vehicle controlled, parallel group, comparator study designed to assess the safety, efficacy and pharmacokinetics of two doses of glycopyrrolate compared to two doses of glycopyrronium compared to vehicle, 5 treatment arms.

Efficacy will be assessed through gravimetric assessment of sweat production using Patient Reported Outcome and the Hyperhidrosis Disease Severity Score (HDSS).

Safety will be assessed through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs.

PK blood samples will be taken study subjects.

Conditions

Hyperhidrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dose 1 of glycopyrrolate, 2.0% QD

glycopyrrolate Topical Wipes

Group Type: EXPERIMENTAL

Dose 1 of glycopyrrolate, 2.0% QD

Intervention Type: DRUG

Dose 1 of glycopyrrolate Topical Wipes

Dose 2 of glycopyrrolate, 3.0% QD

glycopyrrolate Topical Wipes

Group Type: EXPERIMENTAL

Dose 2 of glycopyrrolate, 3.0% QD

Intervention Type: DRUG

Dose 2 of glycopyrrolate Topical Wipes

Dose 1 of glycopyrronium, 2.5% QD

glycopyrronium Topical Wipes

Group Type: ACTIVE_COMPARATOR

Dose 1 of glycopyrronium, 2.5% QD

Intervention Type: DRUG

Dose 1 of glycopyrronium Topical Wipes

Dose 2 of glycopyrronium, 3.75% QD

glycopyrronium Topical Wipes

Group Type: ACTIVE_COMPARATOR

Dose 2 of glycopyrronium, 3.75% QD

Intervention Type: DRUG

Dose 2 of glycopyrronium Topical Wipes

Vehicle

Vehicle Topical Wipes

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: OTHER

Vehicle Topical Wipes

Interventions

Dose 1 of glycopyrrolate, 2.0% QD

Dose 1 of glycopyrrolate Topical Wipes

Intervention Type: DRUG

Dose 2 of glycopyrrolate, 3.0% QD

Dose 2 of glycopyrrolate Topical Wipes

Intervention Type: DRUG

Dose 1 of glycopyrronium, 2.5% QD

Dose 1 of glycopyrronium Topical Wipes

Intervention Type: DRUG

Dose 2 of glycopyrronium, 3.75% QD

Dose 2 of glycopyrronium Topical Wipes

Intervention Type: DRUG

Vehicle

Vehicle Topical Wipes

Intervention Type: OTHER

Other Intervention Names

DRM04B; DRM04B; DRM04; DRM04

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• Menopausal women who have had symptoms of menopause such as sweating or flushing within 3 years of the study may not be enrolled.
• Known 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.
• Abnormal findings on screening ECG deemed clinically significant by the Investigator.
• History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter. History of other supraventricular tachycardia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Journey Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lynne M. Deans, MT

Role: STUDY_DIRECTOR

Dermira, Inc.

Locations

California Dermatology & Clinical Research Institute

Encinitas, California, United States

Center For Dermatology Clinical Research

Fremont, California, United States

Olympian Clinical Research

Tampa, Florida, United States

Kenneth R. Beer MD

West Palm Beach, Florida, United States

Shideler Clinical Research Center

Carmel, Indiana, United States

Saint Louis University Dermatology

St Louis, Missouri, United States

Haber Dermatology and Cosmetic Surgery

Beachwood, Ohio, United States

Rivergate Dermatology Clinical Research Center, PLLC

Goodlettsville, Tennessee, United States

DermResearch, Inc

Austin, Texas, United States

Dermatology Research Center, Inc.

Salt Lake City, Utah, United States

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

Dermatology Associates

Seattle, Washington, United States

Women's Clinical Research Center

Seattle, Washington, United States

Premier Clinical Research

Spokane, Washington, United States

Innovaderm Research Inc.

Montreal, , Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 33433785 (View on PubMed)

Other Identifiers

DRM04-HH02

Identifier Type: -

Identifier Source: org_study_id