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

Palmar Hyperhidrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03880266
• Other study ID #: DRM04-HH10
• Status: Completed
• Phase: Phase 2
• Start date: February 22, 2019
• Est. completion date: May 24, 2019

Study information

• Verified date: August 2021
• Source: Journey Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 24, 2019
• Est. primary completion date: May 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperhidrosis
• Palmar Hyperhidrosis

Intervention

Drug:
• Glycopyrronium cloth, 2.4%
Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium
• Vehicle
Pre-saturated 100% polypropylene, nonwoven, fabric cloth

Locations

Country	Name	City	State
United States	Colorado Medical Research Center, Inc.	Denver	Colorado
United States	California Dermatology & Clinical Research Institute	Encinitas	California
United States	International Dermatology Research, Inc.	Miami	Florida
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	The Indiana Clinical Trials Center	Plainfield	Indiana
United States	Innovative Dermatology/ ACRC Trials	Plano	Texas
United States	Saint Louis University Dermatology	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Journey Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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