A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis
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ClinicalTrials.gov Identifier: NCT03880266 |
Recruitment Status :
Completed
First Posted : March 19, 2019
Results First Posted : March 15, 2021
Last Update Posted : August 25, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Palmar Hyperhidrosis | Drug: Glycopyrronium cloth, 2.4% Drug: Vehicle | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 72 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis |
Actual Study Start Date : | February 22, 2019 |
Actual Primary Completion Date : | May 24, 2019 |
Actual Study Completion Date : | May 24, 2019 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Group 1 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
|
Drug: Glycopyrronium cloth, 2.4%
Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium |
Placebo Comparator: Group 1 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
|
Drug: Vehicle
Pre-saturated 100% polypropylene, nonwoven, fabric cloth |
Active Comparator: Group 2 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
|
Drug: Glycopyrronium cloth, 2.4%
Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium |
Placebo Comparator: Group 2 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
|
Drug: Vehicle
Pre-saturated 100% polypropylene, nonwoven, fabric cloth |
Active Comparator: Group 3 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes
|
Drug: Glycopyrronium cloth, 2.4%
Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium |
Placebo Comparator: Group 3 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 15 minutes
|
Drug: Vehicle
Pre-saturated 100% polypropylene, nonwoven, fabric cloth |
Active Comparator: Group 4 Active
Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes
|
Drug: Glycopyrronium cloth, 2.4%
Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium |
Placebo Comparator: Group 4 Vehicle
Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
|
Drug: Vehicle
Pre-saturated 100% polypropylene, nonwoven, fabric cloth |
- Mean Change From Baseline to Week 2 in Hand Sweating Severity Score [ Time Frame: Baseline, Week 2 ]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)].
- Percentage of Subjects Who Have a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 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

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Ages Eligible for Study: | 9 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880266
United States, California | |
California Dermatology & Clinical Research Institute | |
Encinitas, California, United States, 92024 | |
United States, Colorado | |
Colorado Medical Research Center, Inc. | |
Denver, Colorado, United States, 80210 | |
United States, Florida | |
International Dermatology Research, Inc. | |
Miami, Florida, United States, 33144 | |
United States, Indiana | |
The Indiana Clinical Trials Center | |
Plainfield, Indiana, United States, 46168 | |
United States, Missouri | |
Saint Louis University Dermatology | |
Saint Louis, Missouri, United States, 63122 | |
United States, Texas | |
Innovative Dermatology/ ACRC Trials | |
Plano, Texas, United States, 75024 | |
United States, Virginia | |
Virginia Clinical Research, Inc. | |
Norfolk, Virginia, United States, 23502 |
Study Director: | Kate Doherty | Dermira, Inc. |
Documents provided by Journey Medical Corporation:
Responsible Party: | Journey Medical Corporation |
ClinicalTrials.gov Identifier: | NCT03880266 |
Other Study ID Numbers: |
DRM04-HH10 |
First Posted: | March 19, 2019 Key Record Dates |
Results First Posted: | March 15, 2021 |
Last Update Posted: | August 25, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Hyperhidrosis Sweat Gland Diseases Skin Diseases Glycopyrrolate Adjuvants, Anesthesia Muscarinic Antagonists |
Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |