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

A Phase 2, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis

The objective of this study is to assess the efficacy and safety of glycopyrronium cloth, 2.4% when used to treat palmar hyperhidrosis.

Study Overview

• Status: Completed
• Conditions: Palmar Hyperhidrosis
• Intervention / Treatment: Drug: Glycopyrronium cloth, 2.4%; Drug: Vehicle

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Encinitas, California, United States, 92024
      • California Dermatology & Clinical Research Institute
  • Colorado
    • Denver, Colorado, United States, 80210
      • Colorado Medical Research Center, Inc.
  • Florida
    • Miami, Florida, United States, 33144
      • International Dermatology Research, Inc.
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center
  • Missouri
    • Saint Louis, Missouri, United States, 63122
      • Saint Louis University Dermatology
  • Texas
    • Plano, Texas, United States, 75024
      • Innovative Dermatology/ ACRC Trials
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

8

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)].	Baseline, Week 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline, Week 2
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	Baseline, 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	Baseline, Week 2
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	Baseline, Week 2

Collaborators and Investigators

• Sponsor: Journey Medical Corporation
• Investigators: Study Director: Kate Doherty, Dermira, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 22, 2019
• Primary Completion (ACTUAL): May 24, 2019
• Study Completion (ACTUAL): May 24, 2019

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: March 15, 2019
• First Posted (ACTUAL): March 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Glycopyrrolate
• Other Study ID Numbers: DRM04-HH10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No