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