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

Therapeutics, Inc.240 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

240

Conditions

Tinea Pedis

Interventions

UHE-103A1 creamDRUG

Investigational mono-therapy cream (containing drug A \[low dose\]). Drug A is an antifungal agent.

UHE-103A2 creamDRUG

Investigational mono-therapy cream (containing drug A \[low dose\]). Drug A is an antifungal agent.

UHE-103B creamDRUG

Comparator mono-therapy cream (containing drug B). Drug B is a keratolytic agent.

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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.

Locations (12)

Site 03

San Diego, California, United States

Site 12

Melbourne, Florida, United States

Site 06

Miami, Florida, United States

Site 09

Outcomes

Primary Outcomes

Complete Cure at End of Study

Proportion of subjects with Complete Cure (negative fungal test \& no clinical disease-induced signs and symptoms) at end of study (EOS).

Time frame: Day 43

Secondary Outcomes

Effective treatment

Proportion of subjects with Effective Treatment (negative fungal test \& no to mild clinical disease-induced signs and symptoms) at EOS.

Time frame: Day 43

Mycological Cure

Proportion of subjects with Mycological Cure (negative fungal test) at EOS.

Time frame: Day 43

Data from ClinicalTrials.gov

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