Study of Glycopyrronium in Axillary Hyperhydrosis
Primary Purpose
Hyperhidrosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
glycopyrronium Topical Wipes
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Hyperhidrosis
Eligibility Criteria
Inclusion Criteria:
- Male or female ≥ 9 years of age.
- Primary, axillary hyperhidrosis of at least 6 months duration
- Hyperhidrosis Disease Severity Scale (HDSS) of 3 or 4 at Baseline
- Axillary Sweating Daily Diary (ASDD) ≥ 4 at Baseline
- Sweat production of at least 50 mg over 5 minutes in each axilla assessed gravimetrically
Exclusion Criteria:
- Prior surgical procedure for hyperhidrosis.
- Prior axillary treatment with an anti-hyperhidrosis medical device (approved or investigational).
- Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day 1.
- Previous active treatment in the Dermira DRM04-HH01 or DRM04-HH02 clinical trials.
- Axillary use of nonprescription antiperspirants within 1 week or prescription antiperspirants within 2 weeks of Baseline.
- Subjects on new or regimens of psychotherapeutic medications that have changed within 2 months of baseline.
- Treatment with systemic anticholinergics within 4 weeks of the baseline visit unless dosing has been stable for at least 4 months.
- Other treatment with glycopyrrolate within 4 weeks prior to Baseline.
- Secondary axillary hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis.
- 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.
- History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter.
- Other systemic diseases or active uncontrolled infections, or any other condition which, in the judgment of the Investigator, would put the subject at unacceptable risk for participation in the study.
Sites / Locations
- Coastal Clinical Research, Inc.
- California Dermatology & Clinical Research Institute
- Therapeutics Clinical Research
- Skin Care Research, Inc.
- Study Protocol, Inc.
- International Dermatology Research, Inc.
- Tory Sullivan, M.D., P.A.
- Research Institute of the Southeast
- The Indiana Clinical Trials Center
- Prairie Health and Wellness
- St. Louis University Dermatology
- Meridian Clinical Research
- Dermatology and Laser Center
- Rivergate Dermatology Clinical Research Center, PLLC
- DermResearch
- J&S Studies
- Austin Institute for Clinical Research
- ACRC Trials / Innovative Dermatology
- Texas Dermatology and Laser Specialists
- Charlottesville Dermatology Research Center
- Virginia Clinical Research, Inc.
- Klinik fur Dermatologie, Allergologie und Venerologie Allergie-Centrum-Charite
- Pro DERMA im Hautzentrum Dulmen
- Medical Practice and Derma Study Center Friedrichshafen GmbH
- SRH Wald-Klinikum Gera GmbH
- Hautarztpraxis
- Tagesklinik DermaKiel
- Dermatolosche Gemeinschaftspraxis
- Hautarztpraxis
- Gemeinschaftspraxis Weber & Cranic
- Hautarztpraxis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
glycopyrronium
Vehicle
Arm Description
glycopyrronium Topical Wipes
glycopyrronium Topical Wipes, Vehicle
Outcomes
Primary Outcome Measures
Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of ASDD Item #2 From Baseline at Week 4
The Axillary Sweating Daily Diary (ASDD) is a 4-item instrument designed to measure the severity of axillary hyperhidrosis and its impact on daily activities. The 4 Items are:
During the past 24 hours, did you have any underarm sweating? (Yes or No)
During the past 24 hours, how would you rate your underarm sweating at its worst? (0=No sweating at all, 1, 2,…, 10=Worst possible sweating)
During the past 24 hours, to what extent did your underarm sweating impact your activities? (0=Not at all, 1=A little bit, 2=A moderate amount, 3=A great deal and 4=An extreme amount)
During the past 24 hours, how bothered were you by your underarm sweating? (0=Not at all bothered, 1=A little bothered, 2=Moderately bothered, 3=Very bothered, 4=Extremely bothered)
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at 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.
Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4, Excluding Centers With Outlier Data
Secondary Outcome Measures
Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4
Hyperhidrosis Disease Severity Scale (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)
Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4
Full Information
NCT ID
NCT02530281
First Posted
August 19, 2015
Last Updated
August 23, 2021
Sponsor
Journey Medical Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02530281
Brief Title
Study of Glycopyrronium in Axillary Hyperhydrosis
Official Title
A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Efficacy and Safety Study of Glycopyrronium in Subjects With Axillary Hyperhydrosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (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 study is a randomized, double-blind, vehicle controlled, parallel group study, designed to assess the efficacy and safety of glycopyrronium topical wipes, once daily, compared to vehicle in subjects with axillary hyperhidrosis.
Detailed Description
This is a randomized, double-blind vehicle controlled study to assess the efficacy and safety of glycopyrronium topical wipes compared to vehicle in subjects with axillary hyperhidrosis.
Safety will be assessed through lab tests, ECG, physical exams and vital signs.
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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
344 (Actual)
8. Arms, Groups, and Interventions
Arm Title
glycopyrronium
Arm Type
Experimental
Arm Description
glycopyrronium Topical Wipes
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
glycopyrronium Topical Wipes, Vehicle
Intervention Type
Drug
Intervention Name(s)
glycopyrronium Topical Wipes
Other Intervention Name(s)
DRM04
Intervention Description
Topical wipes containing glycopyrronium
Intervention Type
Other
Intervention Name(s)
Vehicle
Intervention Description
Vehicle (placebo) topical wipes
Primary Outcome Measure Information:
Title
Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of ASDD Item #2 From Baseline at Week 4
Description
The Axillary Sweating Daily Diary (ASDD) is a 4-item instrument designed to measure the severity of axillary hyperhidrosis and its impact on daily activities. The 4 Items are:
During the past 24 hours, did you have any underarm sweating? (Yes or No)
During the past 24 hours, how would you rate your underarm sweating at its worst? (0=No sweating at all, 1, 2,…, 10=Worst possible sweating)
During the past 24 hours, to what extent did your underarm sweating impact your activities? (0=Not at all, 1=A little bit, 2=A moderate amount, 3=A great deal and 4=An extreme amount)
During the past 24 hours, how bothered were you by your underarm sweating? (0=Not at all bothered, 1=A little bothered, 2=Moderately bothered, 3=Very bothered, 4=Extremely bothered)
Time Frame
From Baseline to Week 4
Title
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at 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
From Baseline to Week 4
Title
Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4
Time Frame
From Baseline to Week 4
Title
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4, Excluding Centers With Outlier Data
Time Frame
Baseline - Week 4
Secondary Outcome Measure Information:
Title
Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4
Description
Hyperhidrosis Disease Severity Scale (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
From Baseline to Week 4
Title
Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4
Time Frame
From Baseline to Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female ≥ 9 years of age.
Primary, axillary hyperhidrosis of at least 6 months duration
Hyperhidrosis Disease Severity Scale (HDSS) of 3 or 4 at Baseline
Axillary Sweating Daily Diary (ASDD) ≥ 4 at Baseline
Sweat production of at least 50 mg over 5 minutes in each axilla assessed gravimetrically
Exclusion Criteria:
Prior surgical procedure for hyperhidrosis.
Prior axillary treatment with an anti-hyperhidrosis medical device (approved or investigational).
Prior treatment with botulinum toxin (e.g., Botox®) for axillary hyperhidrosis within 1 year of Baseline/Day 1.
Previous active treatment in the Dermira DRM04-HH01 or DRM04-HH02 clinical trials.
Axillary use of nonprescription antiperspirants within 1 week or prescription antiperspirants within 2 weeks of Baseline.
Subjects on new or regimens of psychotherapeutic medications that have changed within 2 months of baseline.
Treatment with systemic anticholinergics within 4 weeks of the baseline visit unless dosing has been stable for at least 4 months.
Other treatment with glycopyrrolate within 4 weeks prior to Baseline.
Secondary axillary hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis.
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.
History or presence of ventricular arrhythmias, atrial fibrillation, atrial flutter.
Other systemic diseases or active uncontrolled infections, or any other condition which, in the judgment of the Investigator, would put the subject at unacceptable risk for participation in the study.
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
Coastal Clinical Research, Inc.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
California Dermatology & Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Skin Care Research, Inc.
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Study Protocol, Inc.
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
International Dermatology Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Tory Sullivan, M.D., P.A.
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Research Institute of the Southeast
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
The Indiana Clinical Trials Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Prairie Health and Wellness
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
St. Louis University Dermatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63122
Country
United States
Facility Name
Meridian Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Dermatology and Laser Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Rivergate Dermatology Clinical Research Center, PLLC
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
DermResearch
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
J&S Studies
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Austin Institute for Clinical Research
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78860
Country
United States
Facility Name
ACRC Trials / Innovative Dermatology
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Charlottesville Dermatology Research Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Klinik fur Dermatologie, Allergologie und Venerologie Allergie-Centrum-Charite
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Pro DERMA im Hautzentrum Dulmen
City
Dülmen
ZIP/Postal Code
48249
Country
Germany
Facility Name
Medical Practice and Derma Study Center Friedrichshafen GmbH
City
Friedrichshafen
ZIP/Postal Code
88045
Country
Germany
Facility Name
SRH Wald-Klinikum Gera GmbH
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Hautarztpraxis
City
Glückstadt
ZIP/Postal Code
25348
Country
Germany
Facility Name
Tagesklinik DermaKiel
City
Kiel
ZIP/Postal Code
24148
Country
Germany
Facility Name
Dermatolosche Gemeinschaftspraxis
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
Hautarztpraxis
City
Pinneberg
ZIP/Postal Code
25421
Country
Germany
Facility Name
Gemeinschaftspraxis Weber & Cranic
City
Schweinfurt
ZIP/Postal Code
97421
Country
Germany
Facility Name
Hautarztpraxis
City
Stuttgart
ZIP/Postal Code
70499
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32147881
Citation
Hebert AA, Glaser DA, Green L, Hull C, Cather J, Drew J, Gopalan R, Pariser DM. Long-term efficacy and safety of topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Post hoc pediatric subgroup analysis from a 44-week open-label extension study. Pediatr Dermatol. 2020 May;37(3):490-497. doi: 10.1111/pde.14135. Epub 2020 Mar 8.
Results Reference
derived
PubMed Identifier
31111409
Citation
Glaser DA, Hebert AA, Nast A, Werschler WP, Green L, Mamelok RD, Quiring J, Drew J, Pariser DM. A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis. Am J Clin Dermatol. 2019 Aug;20(4):593-604. doi: 10.1007/s40257-019-00446-6.
Results Reference
derived
PubMed Identifier
30378087
Citation
Pariser DM, Hebert AA, Drew J, Quiring J, Gopalan R, Glaser DA. Topical Glycopyrronium Tosylate for the Treatment of Primary Axillary Hyperhidrosis: Patient-Reported Outcomes from the ATMOS-1 and ATMOS-2 Phase III Randomized Controlled Trials. Am J Clin Dermatol. 2019 Feb;20(1):135-145. doi: 10.1007/s40257-018-0395-0.
Results Reference
derived
Learn more about this trial
Study of Glycopyrronium in Axillary Hyperhydrosis
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