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

NCT ID: NCT03897257

Last Updated: 2021-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-15

Study Completion Date

2020-05-05

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Tinea Pedis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Five Arms:

* 3 Arms of Monotherapy : UHE-103A1 cream (Drug A low dose concentration) or UHE-103A2 cream (Drug A high concentration) or UHE-103B cream (Drug B comparator)
* 2 Arms of combination therapy: UHE-103A1B cream (Drug A low dose + Drug B), or UHE-103A2B cream (Drug A high dose + Drug B)
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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UHE-103A1 cream

Topical cream applied twice daily for 2 weeks.

Group Type EXPERIMENTAL

UHE-103A1 cream

Intervention Type DRUG

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

UHE-103A2 cream

Topical cream applied twice daily for 2 weeks.

Group Type EXPERIMENTAL

UHE-103A2 cream

Intervention Type DRUG

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

UHE-103B cream

Topical cream applied twice daily for 2 weeks.

Group Type EXPERIMENTAL

UHE-103B cream

Intervention Type DRUG

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

UHE-103A1B cream

Topical cream applied twice daily for 2 weeks.

Group Type EXPERIMENTAL

UHE-103A1B cream

Intervention Type DRUG

Investigational combination-therapy cream (containing drug A \[low dose antifungal\] + drug B \[keratolytic\]).

UHE-103A2B cream

Topical cream applied twice daily for 2 weeks.

Group Type EXPERIMENTAL

UHE-103A2B cream

Intervention Type DRUG

Investigational combination-therapy cream (containing drug A \[high dose antifungal\] + drug B \[keratolytic\]).

Interventions

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UHE-103A1 cream

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

Intervention Type DRUG

UHE-103A2 cream

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

Intervention Type DRUG

UHE-103B cream

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

Intervention Type DRUG

UHE-103A1B cream

Investigational combination-therapy cream (containing drug A \[low dose antifungal\] + drug B \[keratolytic\]).

Intervention Type DRUG

UHE-103A2B cream

Investigational combination-therapy cream (containing drug A \[high dose antifungal\] + drug B \[keratolytic\]).

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marietta Radona, MD

Role: PRINCIPAL_INVESTIGATOR

Therapeutics, Inc.

Locations

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Site 03

San Diego, California, United States

Site Status

Site 12

Melbourne, Florida, United States

Site Status

Site 06

Miami, Florida, United States

Site Status

Site 09

North Miami Beach, Florida, United States

Site Status

Site 07

Rolling Meadows, Illinois, United States

Site Status

Site 11

Fridley, Minnesota, United States

Site Status

Site 04

Rochester, New York, United States

Site Status

Site 01

Austin, Texas, United States

Site Status

Site 02

Houston, Texas, United States

Site Status

Site 10

San Antonio, Texas, United States

Site Status

Site 05

Norfolk, Virginia, United States

Site Status

Site 08

Cidra, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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146-9252-201

Identifier Type: -

Identifier Source: org_study_id