Back to resultsA Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis
Primary Purpose
Hyperhidrosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
glycopyrrolate, 1.0%
glycopyrrolate, 2.0%
glycopyrrolate, 3.0%
glycopyrrolate, 4.0%
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Hyperhidrosis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Burke Pharmaceutical Research
- Gary M. Petrus, MD, PA
- California Dermatology & Clinical Research Institute
- Center For Dermatology Clinical Research
- Florida Academic Dermatology Center
- Kenneth R. Beer, MD, PA
- Shideler Clinical Research Center
- Cypress Medical Research Center, LLC
- Minnesota Clinical Study Center
- Saint Louis University Dermatology
- Skin Specialists, PC
- The Dermatology Group, PC
- Oregon Medical Research Center
- J&S Studies, Inc.
- Clinical Trials of Texas, Inc.
- Dermatology Research Center, Inc.
- Virginia Clinical Research, Inc.
- Westend Dermatology Associates
- Dermatology Associates
- Women's Clinical Research Center
- Premier Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
glycopyrrolate, 1.0%
glycopyrrolate, 2.0%
glycopyrrolate, 3.0%
glycopyrrolate, 4.0%
Vehicle
Arm Description
glycopyrrolate Topical Wipes, 1.0%
glycopyrrolate Topical Wipes, 2.0%
glycopyrrolate Topical Wipes, 3.0%
glycopyrrolate Topical Wipes, 4.0%
Vehicle Topical Wipes
Outcomes
Primary Outcome Measures
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)
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.
Secondary Outcome Measures
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6
Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 4
The DLQI is a ten question questionnaire, used to measure the impact of skin disease on the quality of life of an affected person. The scoring of each question is as follows: Very much (3), A lot (2), A little (1), Not at all (0), Not relevant (0). Is calculated by summing the score of each question resulting in a max of 30 and a min of 0. Higher the score the more Quality of life is impaired.
Full Information
NCT ID
NCT02016885
First Posted
December 16, 2013
Last Updated
August 23, 2021
Sponsor
Journey Medical Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02016885
Brief Title
A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis
Official Title
A Phase 2, Randomized, Double-Blind, Vehicle Controlled, Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Journey Medical Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This is a randomized, vehicle controlled, dose-ranging study enrolling subjects with axillary hyperhidrosis and designed to assess the safety and efficacy of four doses of glycopyrrolate compared to vehicle. There are 5 arms in this study.
Efficacy will be assessed through the Hyperhidrosis Disease Severity Score (HDSS), Dermatology Life Quality Index (DLQI) and a gravimetric assessment of sweat production.
Safety will be assessed, at specified times during the study, through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs.
PK samples will be taken from 20 to 30 subjects participating in the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
glycopyrrolate, 1.0%
Arm Type
Experimental
Arm Description
glycopyrrolate Topical Wipes, 1.0%
Arm Title
glycopyrrolate, 2.0%
Arm Type
Experimental
Arm Description
glycopyrrolate Topical Wipes, 2.0%
Arm Title
glycopyrrolate, 3.0%
Arm Type
Experimental
Arm Description
glycopyrrolate Topical Wipes, 3.0%
Arm Title
glycopyrrolate, 4.0%
Arm Type
Experimental
Arm Description
glycopyrrolate Topical Wipes, 4.0%
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle Topical Wipes
Intervention Type
Drug
Intervention Name(s)
glycopyrrolate, 1.0%
Other Intervention Name(s)
DRM04B
Intervention Description
glycopyrrolate Topical Wipes, 1.0%
Intervention Type
Drug
Intervention Name(s)
glycopyrrolate, 2.0%
Other Intervention Name(s)
DRM04B
Intervention Description
glycopyrrolate Topical Wipes, 2.0%
Intervention Type
Drug
Intervention Name(s)
glycopyrrolate, 3.0%
Other Intervention Name(s)
DRM04B
Intervention Description
glycopyrrolate Topical Wipes, 3.0%
Intervention Type
Drug
Intervention Name(s)
glycopyrrolate, 4.0%
Other Intervention Name(s)
DRM04B
Intervention Description
glycopyrrolate Topical Wipes, 4.0%
Intervention Type
Other
Intervention Name(s)
Vehicle
Other Intervention Name(s)
Placebo
Intervention Description
Vehicle Topical Wipes
Primary Outcome Measure Information:
Title
Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4
Description
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)
Time Frame
Baseline - Week 4
Title
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 4
Description
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.
Time Frame
Baseline - Week 4
Secondary Outcome Measure Information:
Title
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4
Time Frame
Baseline - Week 4
Title
Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6
Time Frame
Baseline - Week 6
Title
Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6
Time Frame
Baseline - Week 6
Title
Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 4
Description
The DLQI is a ten question questionnaire, used to measure the impact of skin disease on the quality of life of an affected person. The scoring of each question is as follows: Very much (3), A lot (2), A little (1), Not at all (0), Not relevant (0). Is calculated by summing the score of each question resulting in a max of 30 and a min of 0. Higher the score the more Quality of life is impaired.
Time Frame
Baseline - Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynne M Deans, MT
Organizational Affiliation
Dermira, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Gary M. Petrus, MD, PA
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
California Dermatology & Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Center For Dermatology Clinical Research
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Florida Academic Dermatology Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Kenneth R. Beer, MD, PA
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Shideler Clinical Research Center
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Cypress Medical Research Center, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Saint Louis University Dermatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63122
Country
United States
Facility Name
Skin Specialists, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
The Dermatology Group, PC
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
J&S Studies, Inc.
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Dermatology Research Center, Inc.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Westend Dermatology Associates
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Dermatology Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Women's Clinical Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33433785
Citation
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.
Results Reference
derived
Learn more about this trial
A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis
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