Safety, Tolerability, and Pharmacokinetics of UHE-103 Cream in Subjects With Tinea Cruris and/or … (NCT05363449) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability, and Pharmacokinetics of UHE-103 Cream in Subjects With Tinea Cruris and/or Tinea Pedis
United States42 participantsStarted 2022-02-17
Plain-language summary
This Phase 1 study has been designed to determine the safety, tolerability and pharmacokinetics (PK) of UHE 103 Cream compared to Naftin Cream, 2% under maximal use conditions for 2 weeks treatment in subjects with tinea cruris and/or tinea pedis
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject is a male or non-pregnant female 18 years of age or older.
✓. Subject has provided written informed consent.
✓. Subject has a clinical diagnosis of moccasin-type tinea pedis with at least moderate scaling on at least 1 foot at Visit 1/Screening;
✓. Subject has a clinical diagnosis of interdigital tinea pedis with at least moderate scaling on at least 1 foot (without moccasin-type tinea pedis) and tinea cruris at Visit 1/Screening.
✓. Subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
Exclusion criteria
✕. Subject is pregnant, lactating, or is planning to become pregnant during the study.
✕. Subject has any skin pathology or condition that could interfere with the evaluation of the test article or requires use of interfering topical, systemic, or surgical therapy.
✕. Subject has any clinically significant medical abnormality or history of chronic disease (cardiovascular, gastrointestinal, neurological, hematopoietic, immunosuppression \[HIV\], hepatic \[Hepatitis B or C\], psychological, renal systems, or respiratory), including conditions (e.g., gastrointestinal surgery) that may interfere with the absorption, metabolism, or excretion of investigational product.
✕. Subject has used any of the following topical products on the feet or groin within 4 weeks of Visit 2/Enrollment: antifungals, antibacterials, or corticosteroid therapy.
. Subject has applied any topical naftifine products to any part of their body within 4 weeks of Visit 2/Enrollment.
✕. Subject has used topical keratolytics (e.g., urea, ammonium lactate, salicylic acid) on the feet or groin within 1 week of Visit 2/Enrollment.
✕. Subject has used any other topical products on the feet or groin within 24 hours of Visit 2/Enrollment including, but not limited to non-medicated moisturizers, antipruritics, analgesics, anesthetics, etc.
✕. Subject has received systemic antifungal therapy within 8 weeks or 5 half lives of the antifungal (whichever is longer) of Visit 2/Enrollment.