search
Back to results

Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis

Primary Purpose

Hyperhidrosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Glycopyrronium Topical Wipes
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:

  • Completed Day 28 of either the DRM04-HH04 or DRM04-HH05 study with at least 80% treatment compliance
  • Male or females

Exclusion Criteria:

  • Subject has a clinically significant abnormality on physical exam, vital signs or ECG at the Week 4 visit of DRM04-HH04 or DRM04-HH05 study that would make further treatment with glycopyrronium contraindicated
  • Male with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy
  • Any other condition which, in the judgement of the Investigator, would put the subject at unacceptable risk for participation in the study

Sites / Locations

  • Coastal Medical Research Group LLC
  • Northwest Arkansas Clinical Trials Center, PLLC
  • California Dermatology & Clinical Research Institute
  • Dermatology Research Associates
  • Therapeutics Clinical Research
  • Clinical Science Institute
  • Colorado Medical Research Center, Inc
  • Skin Care Research, Inc.
  • Study Protocol, Inc
  • International Dermatology Research, Inc.
  • Tory Sullivan, MD
  • Research Institute of the Southeast
  • Shideler Clinical Research Center
  • The Indiana Clinical Trials Center, PC
  • Prairie Health and Wellness
  • Lawrence J. Green M.D., LLC
  • Zel Skin & Laser Specialist
  • MediSearch Clinical Trials
  • St. Louis University Dermatology
  • Meridian Clinical Research
  • Academic Dermatology Associates
  • Schweiger Dermatology Group
  • Skin Search of Rochester, Inc
  • Oregon Dermatology and Research Center
  • Dermatology and Laser Center of Charleston, PA
  • Rivergate Dermatology Research Center, PLLC
  • Clinical Research Associates, Inc
  • DermResearch
  • J & S Studies, Inc.
  • Modern Research Associates, PLLC
  • The University of Texas Dermatology Clinical Research Center
  • Austin Institute for Clinical Research
  • ACRC Trials
  • Texas Dermatology and Laser Specialists
  • Dermatology Research Center, Inc.
  • Jordan Valley Dermatology Center, LLC
  • Charlottesville Medical Research
  • Virginia Clinical Research, Inc.
  • Dermatology Associates
  • Premier Clinical Research
  • Klinik für Dermatologie, Venerologie und Allergologie Allergie-Centrum-Charité
  • Pro DERMA im Hautzentrum Dulmen
  • Medical Practice and Derma-Study-Center Friedrichshafen GmbH
  • SRH Wald-Klinikum Gera GmbH
  • Hautarztpraxis
  • Tagesklinik DermaKiel
  • Dermatolosche Gemeinschaftspraxis
  • Gemeinschaftspraxis Weber & Cranic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Glycopyrronium

Arm Description

Glycopyrronium Topical Wipes

Outcomes

Primary Outcome Measures

Long-term Safety Assessed Through Adverse Events and Local Skin Reactions
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.

Secondary Outcome Measures

Full Information

First Posted
September 15, 2015
Last Updated
August 23, 2021
Sponsor
Journey Medical Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT02553798
Brief Title
Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis
Official Title
An Open-label Study Assessing Long-term Safety of Glycopyrronium in Subjects With Primary 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
December 2016 (Actual)
Study Completion Date
December 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
This is an open-label, long-term safety study of glycopyrronium topical wipes, enrolling up to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04 or DRM04-HH05 studies.
Detailed Description
Safety will be assessed through adverse events, blood and urine laboratory tests, physical examination, pulse and blood pressure. Local skin reactions will be assessed including burning/stinging, pruritus, edema, erythema, dryness and scaling.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
564 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glycopyrronium
Arm Type
Experimental
Arm Description
Glycopyrronium Topical Wipes
Intervention Type
Drug
Intervention Name(s)
Glycopyrronium Topical Wipes
Other Intervention Name(s)
DRM04
Intervention Description
Glycopyrronium Topical Wipes
Primary Outcome Measure Information:
Title
Long-term Safety Assessed Through Adverse Events and Local Skin Reactions
Description
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
Time Frame
Day 1 - Week 44
Other Pre-specified Outcome Measures:
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 (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET
Title
Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS)
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
Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET
Title
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 44/ET
Description
The Dermatology Life Quality Index 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 (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completed Day 28 of either the DRM04-HH04 or DRM04-HH05 study with at least 80% treatment compliance Male or females Exclusion Criteria: Subject has a clinically significant abnormality on physical exam, vital signs or ECG at the Week 4 visit of DRM04-HH04 or DRM04-HH05 study that would make further treatment with glycopyrronium contraindicated Male with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy Any other condition which, in the judgement 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 Deans, MT
Organizational Affiliation
Dermira, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Coastal Medical Research Group LLC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Northwest Arkansas Clinical Trials Center, PLLC
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
California Dermatology & Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
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
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, MD
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
Shideler Clinical Research Center
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
The Indiana Clinical Trials Center, PC
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
67206
Country
United States
Facility Name
Lawrence J. Green M.D., 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
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
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106-5239
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
Dermatology and Laser Center of Charleston, PA
City
Charleston
State/Province
Pennsylvania
ZIP/Postal Code
29414
Country
United States
Facility Name
Rivergate Dermatology Research Center, PLLC
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
Clinical Research Associates, Inc
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
DermResearch
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
J & S Studies, Inc.
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Modern Research Associates, PLLC
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
Austin Institute for Clinical Research
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78860
Country
United States
Facility Name
ACRC Trials
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
Dermatology Research Center, Inc.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Jordan Valley Dermatology Center, LLC
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Charlottesville Medical Research
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
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
Facility Name
Klinik für Dermatologie, Venerologie und Allergologie Allergie-Centrum-Charité
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
Gemeinschaftspraxis Weber & Cranic
City
Schweinfurt
ZIP/Postal Code
97421
Country
Germany

12. IPD Sharing Statement

Citations:
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

Learn more about this trial

Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis

We'll reach out to this number within 24 hrs