Back to resultsA Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis
Primary Purpose
Palmar Hyperhidrosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Glycopyrronium cloth, 2.4%
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Palmar Hyperhidrosis
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent and assent (for subjects under legal adult age).
- Age ≥9 years.
- Primary palmar hyperhidrosis for at least 6 months duration.
- Average sweat severity score of ≥4 at Baseline.
- Hyperhidrosis Disease Severity Scale of 3 or 4 at Baseline.
- Willing to comply with the protocol. Subjects under legal adult age will be assessed by the investigator as to their ability to comply with the protocol.
- Male or non-pregnant (negative urine pregnancy test in female subjects of child-bearing potential), non-lactating females.
Exclusion Criteria:
- Subjects who have taken or are currently taking glycopyrronium cloth, 2.4%.
- Prior surgical procedure for hyperhidrosis.
- Iontophoresis for the palms within 4 weeks of Baseline.
- Treatment with botulinum toxin (e.g., Botox®) for palmar hyperhidrosis within 1 year of Baseline.
- Open wounds or inflammatory lesions on the hands or, any condition that may alter the barrier function of the skin on the hands.
- Secondary palmar hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis (e.g., lymphoma, malaria, severe anxiety not controlled by medication, carcinoid syndrome, substance abuse, hyperthyroidism).
- Known history of Sjögren's syndrome or Sicca syndrome.
- History of glaucoma, inflammatory bowel disease, toxic megacolon, active febrile illness, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis or myasthenia gravis.
- Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.
Sites / Locations
- California Dermatology & Clinical Research Institute
- Colorado Medical Research Center, Inc.
- International Dermatology Research, Inc.
- The Indiana Clinical Trials Center
- Saint Louis University Dermatology
- Innovative Dermatology/ ACRC Trials
- Virginia Clinical Research, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Arm Label
Group 1 Active
Group 1 Vehicle
Group 2 Active
Group 2 Vehicle
Group 3 Active
Group 3 Vehicle
Group 4 Active
Group 4 Vehicle
Arm Description
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
Outcomes
Primary Outcome Measures
Mean Change From Baseline to Week 2 in Hand Sweating Severity Score
The Hand Sweat Severity Score is a patient reported outcome, designed to measure the severity of palmar hyperhidrosis [score on a scale from 0 (better) -10 (worse)].
Secondary Outcome Measures
Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2
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 (better), 2, 3, 4 (worse)
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2
Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; average of the change in the gravimetric measurement of sweat produced at baseline compared with Week 2
Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2
Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; calculation of percentage difference in sweat production at week 2 compared to baseline sweat production
Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2
Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; confidence interval represents difference between vehicle and active group
Full Information
NCT ID
NCT03880266
First Posted
March 15, 2019
Last Updated
August 23, 2021
Sponsor
Journey Medical Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03880266
Brief Title
A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis
Official Title
A Phase 2, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 22, 2019 (Actual)
Primary Completion Date
May 24, 2019 (Actual)
Study Completion Date
May 24, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Journey Medical Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to assess the efficacy and safety of glycopyrronium cloth, 2.4% when used to treat palmar hyperhidrosis.
Detailed Description
This is a pilot study assessing the safety and efficacy of glycopyrronium cloth in patients with palmar hyperhidrosis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palmar Hyperhidrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 Active
Arm Type
Active Comparator
Arm Description
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
Arm Title
Group 1 Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
Arm Title
Group 2 Active
Arm Type
Active Comparator
Arm Description
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
Arm Title
Group 2 Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
Arm Title
Group 3 Active
Arm Type
Active Comparator
Arm Description
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes
Arm Title
Group 3 Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes
Arm Title
Group 4 Active
Arm Type
Active Comparator
Arm Description
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes
Arm Title
Group 4 Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
Intervention Type
Drug
Intervention Name(s)
Glycopyrronium cloth, 2.4%
Intervention Description
Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Pre-saturated 100% polypropylene, nonwoven, fabric cloth
Primary Outcome Measure Information:
Title
Mean Change From Baseline to Week 2 in Hand Sweating Severity Score
Description
The Hand Sweat Severity Score is a patient reported outcome, designed to measure the severity of palmar hyperhidrosis [score on a scale from 0 (better) -10 (worse)].
Time Frame
Baseline, Week 2
Secondary Outcome Measure Information:
Title
Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2
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 (better), 2, 3, 4 (worse)
Time Frame
Baseline, Week 2
Title
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2
Description
Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; average of the change in the gravimetric measurement of sweat produced at baseline compared with Week 2
Time Frame
Baseline, Week 2
Title
Mean Percent Change From Baseline in Gravimetrically-measured Sweat Production at Week 2
Description
Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; calculation of percentage difference in sweat production at week 2 compared to baseline sweat production
Time Frame
Baseline, Week 2
Title
Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2
Description
Gravimetrically measured sweat production is based on the mean of the right and left hand measurements; confidence interval represents difference between vehicle and active group
Time Frame
Baseline, Week 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent and assent (for subjects under legal adult age).
Age ≥9 years.
Primary palmar hyperhidrosis for at least 6 months duration.
Average sweat severity score of ≥4 at Baseline.
Hyperhidrosis Disease Severity Scale of 3 or 4 at Baseline.
Willing to comply with the protocol. Subjects under legal adult age will be assessed by the investigator as to their ability to comply with the protocol.
Male or non-pregnant (negative urine pregnancy test in female subjects of child-bearing potential), non-lactating females.
Exclusion Criteria:
Subjects who have taken or are currently taking glycopyrronium cloth, 2.4%.
Prior surgical procedure for hyperhidrosis.
Iontophoresis for the palms within 4 weeks of Baseline.
Treatment with botulinum toxin (e.g., Botox®) for palmar hyperhidrosis within 1 year of Baseline.
Open wounds or inflammatory lesions on the hands or, any condition that may alter the barrier function of the skin on the hands.
Secondary palmar hyperhidrosis or presence of a condition that may cause secondary hyperhidrosis (e.g., lymphoma, malaria, severe anxiety not controlled by medication, carcinoid syndrome, substance abuse, hyperthyroidism).
Known history of Sjögren's syndrome or Sicca syndrome.
History of glaucoma, inflammatory bowel disease, toxic megacolon, active febrile illness, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis or myasthenia gravis.
Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate Doherty
Organizational Affiliation
Dermira, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
California Dermatology & Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Colorado Medical Research Center, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
International Dermatology Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
The Indiana Clinical Trials Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Saint Louis University Dermatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63122
Country
United States
Facility Name
Innovative Dermatology/ ACRC Trials
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis
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