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

Phase 2

Completed

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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Group 3 Active	Glycopyrronium cloth, 2.4%	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes
Group 1 Active	Glycopyrronium cloth, 2.4%	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
Group 3 Vehicle	Vehicle	Vehicle cloth applied to the hands once daily for 14 days: 15 minutes
Group 1 Vehicle	Vehicle	Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)
Group 4 Active	Glycopyrronium cloth, 2.4%	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes
Group 4 Vehicle	Vehicle	Vehicle cloth applied to the hands once daily for 14 days: 30 minutes
Group 2 Active	Glycopyrronium cloth, 2.4%	Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)
Group 2 Vehicle	Vehicle	Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline to Week 2 in Hand Sweating Severity Score	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

Name	Time	Method
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 2	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	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 a ≥2 Grade Improvement in HDSS (Hyperhidrosis Disease Severity Scale) From Baseline at Week 2	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)
Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically-measured Sweat Production From Baseline at Week 2	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

Locations (7): International Dermatology Research, Inc.
🇺🇸
Miami, Florida, United States
Virginia Clinical Research, Inc.
🇺🇸
Norfolk, Virginia, United States
California Dermatology & Clinical Research Institute
🇺🇸
Encinitas, California, United States
Innovative Dermatology/ ACRC Trials
🇺🇸
Plano, Texas, United States
The Indiana Clinical Trials Center
🇺🇸
Plainfield, Indiana, United States
Colorado Medical Research Center, Inc.
🇺🇸
Denver, Colorado, United States
Saint Louis University Dermatology
🇺🇸
Saint Louis, Missouri, United States