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

Completed · Phase 2

Conditions studied: Palmar Hyperhidrosis

In brief

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

Key facts

Study ID

NCT03880266

Run by

Journey Medical Corporation

People needed

72

Starts

2019-02-22

Expected to finish

2019-05-24

Last updated by the study team

2021-08-25

Who can join

Age: 9 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• California Dermatology & Clinical Research Institute — Encinitas, California, United States
• Colorado Medical Research Center, Inc. — Denver, Colorado, United States
• International Dermatology Research, Inc. — Miami, Florida, United States
• The Indiana Clinical Trials Center — Plainfield, Indiana, United States
• Saint Louis University Dermatology — St Louis, Missouri, United States
• Innovative Dermatology/ ACRC Trials — Plano, Texas, United States
• Virginia Clinical Research, Inc. — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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