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

Therapeutics, Inc.

Status and phase

Completed

Phase 2

Conditions

Tinea Pedis

Treatments

Drug: UHE-103A2 cream

Drug: UHE-103A1B cream

Drug: UHE-103A1 cream

Drug: UHE-103B cream

Drug: UHE-103A2B cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT03897257

146-9252-201

Details and patient eligibility

About

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.

Full description

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).

Enrollment

240 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

240 participants in 5 patient groups

UHE-103A1 cream

Experimental group

Description: