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Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis

Primary Purpose

Hyperhidrosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
glycopyrronium Topical Wipes
Vehicle
Sponsored by
Journey Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperhidrosis

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

  • Northwest Arkansas Clinical Trials Center, PLLC
  • Dermatology Research Associates
  • Clinical Science Institute
  • Colorado Medical Research Center, Inc.
  • Shideler Clinical Research Center
  • Lawrence J Green, MD LLC
  • Zel Skin & Laser Specialist
  • MediSearch Clinical Trials
  • Clinical Studies Group, LLC
  • Academic Dermatology Associates
  • Schweiger Dermatology Group
  • Skin Search of Rochester, Inc.
  • Oregon Dermatology and Research Center
  • Clinical Research Associates, Inc.
  • Modern Research Associates
  • The University of Texas Dermatology Clinical Research Center
  • Dermatology Research Center, Inc.
  • Jordan Valley Dermatology Center
  • Dermatology Associates
  • Premier Clinical Research

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 Axillary Sweating Daily Diary (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

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.
Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4

Full Information

First Posted
August 19, 2015
Last Updated
August 23, 2021
Sponsor
Journey Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02530294
Brief Title
Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis
Official Title
A Phase 3, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 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
353 (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 Axillary Sweating Daily Diary (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
Baseline - Week 4
Title
Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4
Time Frame
From Baseline to 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.
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
Northwest Arkansas Clinical Trials Center, PLLC
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Colorado Medical Research Center, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Shideler Clinical Research Center
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Lawrence J Green, MD LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Zel Skin & Laser Specialist
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55424
Country
United States
Facility Name
MediSearch Clinical Trials
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Clinical Studies Group, LLC
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89044
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Schweiger Dermatology Group
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Skin Search of Rochester, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Clinical Research Associates, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Modern Research Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
The University of Texas Dermatology Clinical Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
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
Jordan Valley Dermatology Center
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Dermatology Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

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 Subjects With Axillary Hyperhidrosis

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