A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis

• ClinicalTrials.gov Identifier: NCT03880266
• Recruitment Status: Completed
• First Posted: March 19, 2019
• Results First Posted: March 15, 2021
• Last Update Posted: August 25, 2021
• Sponsor: Journey Medical Corporation
• Information provided by (Responsible Party): Journey Medical Corporation

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.

Condition or disease	Intervention/treatment	Phase
Palmar Hyperhidrosis	Drug: Glycopyrronium cloth, 2.4%; Drug: Vehicle	Phase 2

Detailed Description:

This is a pilot study assessing the safety and efficacy of glycopyrronium cloth in patients with palmar hyperhidrosis

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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)].

Secondary Outcome Measures :

1. 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)

2. 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
3. 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
4. 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

Eligibility Criteria

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

Criteria

Inclusion Criteria:

1. Signed informed consent and assent (for subjects under legal adult age).
2. Age ≥9 years.
3. Primary palmar hyperhidrosis for at least 6 months duration.
4. Average sweat severity score of ≥4 at Baseline.
5. Hyperhidrosis Disease Severity Scale of 3 or 4 at Baseline.
6. 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.
7. Male or non-pregnant (negative urine pregnancy test in female subjects of child-bearing potential), non-lactating females.

Exclusion Criteria:

1. Subjects who have taken or are currently taking glycopyrronium cloth, 2.4%.
2. Prior surgical procedure for hyperhidrosis.
3. Iontophoresis for the palms within 4 weeks of Baseline.
4. Treatment with botulinum toxin (e.g., Botox®) for palmar hyperhidrosis within 1 year of Baseline.
5. Open wounds or inflammatory lesions on the hands or, any condition that may alter the barrier function of the skin on the hands.
6. 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).
7. Known history of Sjögren's syndrome or Sicca syndrome.
8. 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.
9. Men with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy.

Contacts and Locations

Locations

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

Sponsors and Collaborators

Journey Medical Corporation

Investigators

• Study Director: Kate Doherty; Dermira, Inc.

  Study Documents (Full-Text)

Documents provided by Journey Medical Corporation:

Study Protocol and Statistical Analysis Plan  [PDF] December 11, 2018

More Information

• Responsible Party: Journey Medical Corporation
• ClinicalTrials.gov Identifier: NCT03880266
• Other Study ID Numbers: DRM04-HH10
• First Posted: March 19, 2019
• 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

Additional relevant MeSH terms:

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