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

A Phase 2, Randomized, Double-Blind Vehicle-Controlled Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis

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.

Study Overview

• Status: Completed
• Conditions: Hyperhidrosis
• Intervention / Treatment: Drug: Dose 1 of glycopyrrolate, 2.0% QD; Drug: Dose 2 of glycopyrrolate, 3.0% QD; Drug: Dose 1 of glycopyrronium, 2.5% QD; Drug: Dose 2 of glycopyrronium, 3.75% QD; Other: Vehicle

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Montreal, Canada, H2K 4L5
    • Innovaderm Research Inc.
• United States
  • California
    • Encinitas, California, United States, 92024
      • California Dermatology & Clinical Research Institute
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research
  • Florida
    • Tampa, Florida, United States, 33609
      • Olympian Clinical Research
    • West Palm Beach, Florida, United States, 33401
      • Kenneth R. Beer MD
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Shideler Clinical Research Center
  • Missouri
    • Saint Louis, Missouri, United States, 63122
      • Saint Louis University Dermatology
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Haber Dermatology and Cosmetic Surgery
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • Rivergate Dermatology Clinical Research Center, PLLC
  • Texas
    • Austin, Texas, United States, 78759
      • DermResearch, Inc
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Dermatology Research Center, Inc.
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research, Inc.
  • Washington
    • Seattle, Washington, United States, 98105
      • Women's Clinical Research Center
    • Seattle, Washington, United States, 98101
      • Dermatology Associates
    • Spokane, Washington, United States, 99204
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose 1 of glycopyrrolate, 2.0% QD; glycopyrrolate Topical Wipes	Drug: Dose 1 of glycopyrrolate, 2.0% QD; Dose 1 of glycopyrrolate Topical Wipes; Other Names: DRM04B
Experimental: Dose 2 of glycopyrrolate, 3.0% QD; glycopyrrolate Topical Wipes	Drug: Dose 2 of glycopyrrolate, 3.0% QD; Dose 2 of glycopyrrolate Topical Wipes; Other Names: DRM04B
Active Comparator: Dose 1 of glycopyrronium, 2.5% QD; glycopyrronium Topical Wipes	Drug: Dose 1 of glycopyrronium, 2.5% QD; Dose 1 of glycopyrronium Topical Wipes; Other Names: DRM04
Active Comparator: Dose 2 of glycopyrronium, 3.75% QD; glycopyrronium Topical Wipes	Drug: Dose 2 of glycopyrronium, 3.75% QD; Dose 2 of glycopyrronium Topical Wipes; Other Names: DRM04
Placebo Comparator: Vehicle; Vehicle Topical Wipes	Other: Vehicle; Vehicle Topical Wipes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: April 30, 2014
• First Submitted That Met QC Criteria: April 30, 2014
• First Posted (Estimate): May 2, 2014

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-HH02