This is a single-center, prospective, open-label, outpatient pilot study evaluating the efficacy and tolerability of oxybutynin gel for axillary hyperhidrosis.
This study will determine if daily application of topical oxybutynin 3% gel reduces the symptoms of primary axillary hyperhidrosis in adolescents and young adults. It will also assess the impact of daily topical oxybutynin 3% gel on Health Related Quality of Life (HRQOL); determine if daily topical oxybutynin 3% gel has a treatment effect at distant, untreated sites; and assess the local and systemic tolerability of daily topical oxybutynin 3% gel. Finally, the study will determine the treatment effect size, if one exists, in order to power a larger, placebo-controlled study in the future.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Children's Hospital, Colorado
Aurora, Colorado, United States
Number of Patients With Improvement in Hyperhidrosis Severity at Week 1 or Week 4 as Measured by the Hyperhidrosis Disease Severity Scale (HDSS).
A treatment responder is defined as any participant with a change in the Hyperhidrosis Disease Severity Scale (HDSS) score from a baseline score of 3 or 4 to a score of 1 or 2 at week 1 or week 4.
Time frame: Week 1 and week 4
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