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



Status:Recruiting
Healthy:No
Age Range:9 - Any
Updated:3/24/2019
Start Date:February 22, 2019
End Date:August 22, 2019
Contact:Adrienne Vinson
Email:avinson@medtrials.com
Phone:214-630-0288

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A Phase 2, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis

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


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. HDSS 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 Qbrexza (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.
We found this trial at
8
sites
Plainfield, Indiana 46168
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Denver, Colorado 80210
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Denver, CO
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Encinitas, CA
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Miami, FL
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Norfolk, Virginia 23507
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Norfolk, VA
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Plano, TX
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Saint Louis, Missouri 63104
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Saint Louis, MO
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