Overview

A Pilot Study Exploring the Efficacy and Safety of Topical Oxybutynin 3% Gel for Primary Focal Hyperhidrosis in Adolescents and Young Adults

Status:
Completed
Trial end date:
2017-05-01
Target enrollment:
0
Participant gender:
All
Summary
This is a single-center, prospective, open-label, outpatient pilot study evaluating the efficacy and tolerability of oxybutynin gel for axillary hyperhidrosis.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Colorado, Denver
Collaborator:
Society for Pediatric Dermatology
Treatments:
Mandelic Acids
Oxybutynin
Criteria
Inclusion Criteria:

- Eligible subjects must be 12-25 years old and meet consensus criteria for primary
focal hyperhidrosis: focal, visible, excessive sweating of at least 6 months duration
without apparent cause with at least two of the following characteristics: 1)
Bilateral and relatively symmetric, 2) Impairs daily activities, 3) Frequency of at
least one episode per week, 4) Age of onset less than 25 years, 5) Positive family
history, 6) Cessation of focal sweating during sleep.

- Eligible subjects must have moderate to severe hyperhidrosis which correlates to a
score of 3 or 4 on the HDSS.

- Hyperhidrosis must affect the bilateral axilla; however, patients with concurrent
focal hyperhidrosis affecting the palms, soles, face, or other area will not be
excluded.

- Subjects must be willing to comply with the study protocol.

Exclusion Criteria:

- Subjects with hyperhidrosis of less than 6 months duration or hyperhidrosis secondary
to an underlying infectious, endocrine, or neurologic disorder.

- Treatment with botulinum toxin injections to the axillae or other affected areas
within the last 12 weeks OR treatment with other agents (oral anticholinergic
medications, topical aluminum chloride) in the last 4 weeks.

- Subjects with active skin inflammation or infection affecting the axilla

- Subjects who report history of closed-angle glaucoma, urinary retention, decreased
gastrointestinal motility, hiatal hernia, cardiac arrhythmia, coronary artery disease,
congestive health failure, hyperthyroidism, myasthenia gravis, xerostomia, renal
insufficiency, or hepatic impairment.

- Subjects with hypertension defined as systolic blood pressure > 140 or diastolic blood
pressure > 90 on more than 1 occasion separated by 1 week.

- Subjects with the following: history of somnolence, confusion, hallucinations OR
subjects taking other medications that may cause somnolence, confusion, hallucinations
OR subjects with other medical conditions that may predispose them for somnolence,
confusion, or hallucinations.

- Subjects who have demonstrated hypersensitivity to the drug substance or other
components of the product

- Subjects taking drugs which inhibit Cytochrome P450 3A4 (CYP3A4)

- Pregnant and/or nursing females

- Any other disease that would interfere with the study or place them at undue risk or
who are in any way unable to comply with study requirements.