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

• Status: Completed
• Trial end date: 2019-05-24
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dermira, Inc.; Journey Medical Corporation
• Treatments: Glycopyrrolate

Criteria

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.