Status:
COMPLETED
Safety, Tolerability, and Pharmacokinetics of UHE-103 Cream in Subjects With Tinea Cruris and/or Tinea Pedis
Lead Sponsor:
Therapeutics, Inc.
Conditions:
Tinea Cruris
Tinea Pedis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
- Subject is currently enrolled in an investigational drug, biologic, or device study.
- Subject has previously been enrolled in a study for UHE-103.
- Subject has used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to Visit 2/Enrollment.
- Subject has a history of sensitivity to any of the ingredients in the test articles.
Key Trial Info
Start Date :
February 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2023
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05363449
Start Date
February 17 2022
End Date
November 14 2023
Last Update
April 10 2024
Active Locations (5)
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1
Site #1
San Diego, California, United States, 92123
2
Site #5
Thousand Oaks, California, United States, 91320
3
Site #2
Austin, Texas, United States, 78759
4
Site #3
College Station, Texas, United States, 77845