Overview

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

Status:
Completed
Trial end date:
2020-05-05
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Therapeutics, Inc.
Criteria
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.