CompletedPhase 2

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

United States72 participantsStarted 2019-02-22

Plain-language summary

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

Age range9 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Mean Change From Baseline to Week 2 in Hand Sweating Severity Score

Timeframe: Baseline, Week 2

NCT IDNCT03880266

SponsorJourney Medical Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-05-24

Results submitted2020-10-20

Who can participate

Age range9 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.