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

Journey Medical

Status and phase: Completed; Phase 2

Conditions: Palmar Hyperhidrosis

Treatments: Drug: Vehicle; Drug: Glycopyrronium cloth, 2.4%

Study type: Interventional

Funder types: Industry

Identifiers

NCT03880266

DRM04-HH10

Details and patient eligibility

About

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

Full description

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

Enrollment: 72 patients

Sex: All

Ages: 9+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 8 patient groups, including a placebo group

Group 1 Active

Active Comparator group

Description:

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

Treatment:

Drug: Glycopyrronium cloth, 2.4%

Group 1 Vehicle

Placebo Comparator group

Description:

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

Treatment:

Drug: Vehicle

Group 2 Active

Active Comparator group

Description:

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

Treatment:

Drug: Glycopyrronium cloth, 2.4%

Group 2 Vehicle

Placebo Comparator group

Description:

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

Treatment:

Drug: Vehicle

Group 3 Active

Active Comparator group

Description:

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

Treatment:

Drug: Glycopyrronium cloth, 2.4%

Group 3 Vehicle

Placebo Comparator group

Description:

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

Treatment:

Drug: Vehicle

Group 4 Active

Active Comparator group

Description:

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

Treatment:

Drug: Glycopyrronium cloth, 2.4%

Group 4 Vehicle

Placebo Comparator group

Description:

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

Treatment:

Drug: Vehicle