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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
UHE-103 is an investigational combinational therapy containing keratolytic and antifungal
Naftin (naftifine hydrochloride) Cream, 2%. Topical cream containing active drug
Site #1
San Diego, California, United States
Site #5
Thousand Oaks, California, United States
Site #2
Austin, Texas, United States
Site #3
College Station, Texas, United States
Site #4
Adverse Events (AEs)
Percentage of subjects with any local and systemic AEs defined as "possibly" or "probably" or "definitely" related by the investigator.
Time frame: Baseline up to Day 16
Local Skin Reactions (LSRs)
Percentage of subjects with presence of any of the following LSRs at the end of the study: burning/stinging, edema, and oozing/vesiculation/crusting.
Time frame: Day 16
AUC (0-12 hours)
Defined as the area concentration-time curve (AUC) of the active antifungal drug from time 0 to 12 hours.
Time frame: Day 15
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Houston, Texas, United States