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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-22

Study Completion Date

2019-05-24

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.

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Detailed Description

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

Conditions

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Palmar Hyperhidrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 1 Active

Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)

Group Type ACTIVE_COMPARATOR

Glycopyrronium cloth, 2.4%

Intervention Type DRUG

Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium

Group 1 Vehicle

Vehicle cloth applied to the hands once daily for 14 days: 15 minutes with occlusion (non-latex glove)

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Pre-saturated 100% polypropylene, nonwoven, fabric cloth

Group 2 Active

Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)

Group Type ACTIVE_COMPARATOR

Glycopyrronium cloth, 2.4%

Intervention Type DRUG

Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium

Group 2 Vehicle

Vehicle cloth applied to the hands once daily for 14 days: 30 minutes with occlusion (non-latex glove)

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Pre-saturated 100% polypropylene, nonwoven, fabric cloth

Group 3 Active

Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 15 minutes

Group Type ACTIVE_COMPARATOR

Glycopyrronium cloth, 2.4%

Intervention Type DRUG

Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium

Group 3 Vehicle

Vehicle cloth applied to the hands once daily for 14 days: 15 minutes

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Pre-saturated 100% polypropylene, nonwoven, fabric cloth

Group 4 Active

Glycopyrronium cloth, 2.4% applied to the hands once daily for 14 days: 30 minutes

Group Type ACTIVE_COMPARATOR

Glycopyrronium cloth, 2.4%

Intervention Type DRUG

Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium

Group 4 Vehicle

Vehicle cloth applied to the hands once daily for 14 days: 30 minutes

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Pre-saturated 100% polypropylene, nonwoven, fabric cloth

Interventions

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Glycopyrronium cloth, 2.4%

Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium

Intervention Type DRUG

Vehicle

Pre-saturated 100% polypropylene, nonwoven, fabric cloth

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No