A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis
A Phase 2, Randomized, Double-Blind, Vehicle Controlled, Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis
1 other identifier
interventional
198
1 country
21
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of glycopyrrolate compared to vehicle for the treatment of axillary hyperhidrosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2013
Shorter than P25 for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 16, 2013
CompletedFirst Posted
Study publicly available on registry
December 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedResults Posted
Study results publicly available
September 13, 2018
CompletedAugust 25, 2021
August 1, 2021
10 months
December 16, 2013
July 17, 2018
August 23, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (4)
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4
Baseline - Week 4
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6
Baseline - Week 6
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6
Baseline - Week 6
Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 4
Baseline - Week 4
Study Arms (5)
glycopyrrolate, 1.0%
EXPERIMENTALglycopyrrolate Topical Wipes, 1.0%
glycopyrrolate, 2.0%
EXPERIMENTALglycopyrrolate Topical Wipes, 2.0%
glycopyrrolate, 3.0%
EXPERIMENTALglycopyrrolate Topical Wipes, 3.0%
glycopyrrolate, 4.0%
EXPERIMENTALglycopyrrolate Topical Wipes, 4.0%
Vehicle
PLACEBO COMPARATORVehicle Topical Wipes
Interventions
Eligibility Criteria
You may qualify if:
- Male or female, 18 years of age or older.
- Primary, axillary hyperhidrosis of at least 6 months duration.
- A Hyperhidrosis Disease Severity Score (HDSS) of 3or 4.
- A gravimetric measurement of sweat production of at least 50 mg over 5 minutes in each axilla (total of 100 mg) while at rest at room temperature.
- Male or non-pregnant, non-lactating females.
You may not qualify if:
- Prior surgical procedure for hyperhidrosis.
- Any prior treatment with an axillary anti-hyperhidrosis medical device (approved or investigational)
- Prior treatment with botulinum toxin for axillary hyperhidrosis within 1 year.
- Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis. Treatment with psychotherapeutic medications for less than 4 months prior to study enrollment. - Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks prior to enrollment.
- Prior axillary treatment with axillary iontophoresis within 4 weeks.
- Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.
- Known history of a condition that may cause secondary hyperhidrosis.
- Known history of Sjögren's syndrome or Sicca syndrome.
- Abnormal findings on screening ECG deemed clinically significant by the Investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913, United States
Gary M. Petrus, MD, PA
Little Rock, Arkansas, 72202, United States
California Dermatology & Clinical Research Institute
Encinitas, California, 92024, United States
Center For Dermatology Clinical Research
Fremont, California, 94538, United States
Florida Academic Dermatology Center
Miami, Florida, 33136, United States
Kenneth R. Beer, MD, PA
West Palm Beach, Florida, 33401, United States
Shideler Clinical Research Center
Carmel, Indiana, 46032, United States
Cypress Medical Research Center, LLC
Wichita, Kansas, 67226, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
Saint Louis University Dermatology
St Louis, Missouri, 63122, United States
Skin Specialists, PC
Omaha, Nebraska, 68144, United States
The Dermatology Group, PC
Verona, New Jersey, 07044, United States
Oregon Medical Research Center
Portland, Oregon, 97223, United States
J&S Studies, Inc.
College Station, Texas, 77845, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84117, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507, United States
Westend Dermatology Associates
Richmond, Virginia, 23233, United States
Dermatology Associates
Seattle, Washington, 98101, United States
Women's Clinical Research Center
Seattle, Washington, 98105, United States
Premier Clinical Research
Spokane, Washington, 99204, United States
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: 33433785DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eugene A. Bauer, MD, Chief Medical Officer
- Organization
- Dermira Inc.
Study Officials
- STUDY DIRECTOR
Lynne M Deans, MT
Dermira, Inc.
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
December 16, 2013
First Posted
December 20, 2013
Study Start
November 1, 2013
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
August 25, 2021
Results First Posted
September 13, 2018
Record last verified: 2021-08