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

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

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

Conditions
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Palmar Hyperhidrosis

Intervention / Treatment
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* Drug: Glycopyrronium cloth, 2.4%
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 Active<br>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%<br>* Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium<br>|
| Placebo Comparator: Group 1 Vehicle<br>Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove) | Drug: Vehicle<br>* Pre-saturated 100% polypropylene, nonwoven, fabric cloth<br>|
| Active Comparator: Group 2 Active<br>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%<br>* Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium<br>|
| Placebo Comparator: Group 2 Vehicle<br>Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove) | Drug: Vehicle<br>* Pre-saturated 100% polypropylene, nonwoven, fabric cloth<br>|
| Active Comparator: Group 3 Active<br>Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes | Drug: Glycopyrronium cloth, 2.4%<br>* Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium<br>|
| Placebo Comparator: Group 3 Vehicle<br>Vehicle cloth applied to the hands once daily for 14 days: 15 minutes | Drug: Vehicle<br>* Pre-saturated 100% polypropylene, nonwoven, fabric cloth<br>|
| Active Comparator: Group 4 Active<br>Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes | Drug: Glycopyrronium cloth, 2.4%<br>* Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium<br>|
| Placebo Comparator: Group 4 Vehicle<br>Vehicle cloth applied to the hands once daily for 14 days: 30 minutes | Drug: Vehicle<br>* Pre-saturated 100% polypropylene, nonwoven, fabric cloth<br>|

What is the study measuring?
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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 |