A Comparison Study of UHE-103 Cream in Subjects With Moccasin Type Tinea Pedis

A Multicenter, Randomized, Double-Blinded, Parallel Group Comparison Study of the Safety and Efficacy of UHE-103 in Subjects With Moccasin-Type Tinea Pedis

The study is being done to determine and compare the safety and effectiveness of an investigational combination therapy (low and high concentrations) versus mono-therapy (low and high concentrations) or mono-therapy (fixed concentration) in subjects with moccasin type tinea pedis.

UHE-103 cream is an investigational combination drug to treat moccasin type tinea pedis, a fungal infection that affects the feet and toes. Eligible subjects will be assigned to one of the 5 possible treatment groups and participate for a total of 6 weeks. Subjects will apply their assigned test drug twice daily for 2 weeks. Each subject will then be assessed for safety and efficacy at week 4 and week 6. There will be a total of 5 clinic visits: 1 screening/baseline visit (Day 1), 2 treatment visits (Days 8 and 15), and 2 follow-up visits (Days 29 and 43).

Inclusion Criteria:

• Male or non-pregnant female, 16 years of age or older.
• Clinical diagnosis of moccasin type tinea pedis
• Microscopic evidence (positive KOH) of the presence of fungi
• Provided written informed consent/assent
• In general good health

Exclusion Criteria:

• Pregnant or lactating or planning to get pregnant while on the study
• Has concurrent tinea infection (e.g., tinea versicolor, tinea cruris)
• Other skin disease which might interfere with the evaluation of tinea pedis
• History of diabetes mellitus or is immunocompromised
• Currently enrolled in an investigational drug or device study
• Used an investigational drug or investigational device treatment within 30 days prior to Visit 1 (Study Day 1)/Baseline

Other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.