Completed

An Open Label, Parallel Group Comparison Study To Evaluate the Safety Tolerability, and Pharmacokinetics of UHE-103 Cream Versus Naftin Cream in Subjects With Tinea Cruris and/or Tinea Pedis Under Maximal Use Conditions

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What is being tested

UHE-103 Cream

+ Naftin (naftifine hydrochloride) Cream

Drug
Who is being recruted

Tinea Cruris+16

+ Bacterial Infections and Mycoses

+ Dermatitis

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: February 2022
See protocol details

Summary

Principal SponsorTherapeutics, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 17, 2022

Actual date on which the first participant was enrolled.

This Phase 1 study has been designed to determine the safety, tolerability and pharmacokinetics (PK) of UHE 103 Cream compared to Naftin Cream, 2% under maximal use conditions for 2 weeks treatment in subjects with tinea cruris and/or tinea pedis

Official TitleAn Open Label, Parallel Group Comparison Study To Evaluate the Safety Tolerability, and Pharmacokinetics of UHE-103 Cream Versus Naftin Cream in Subjects With Tinea Cruris and/or Tinea Pedis Under Maximal Use Conditions
NCT05363449
Principal SponsorTherapeutics, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

42 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Tinea CrurisBacterial Infections and MycosesDermatitisDermatomycosesFoot DermatosesFoot DiseasesInfectionsIntertrigoMycosesPruritusSigns and SymptomsSkin DiseasesSkin Diseases, InfectiousSkin ManifestationsPathological Conditions, Signs and SymptomsTineaTinea PedisSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Criteria

5 inclusion criteria required to participate
Subject is a male or non-pregnant female 18 years of age or older.
Subject has provided written informed consent.
Subject has a clinical diagnosis of moccasin-type tinea pedis with at least moderate scaling on at least 1 foot at Visit 1/Screening;
Subject has a clinical diagnosis of interdigital tinea pedis with at least moderate scaling on at least 1 foot (without moccasin-type tinea pedis) and tinea cruris at Visit 1/Screening.
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12 exclusion criteria prevent from participating
Subject is pregnant, lactating, or is planning to become pregnant during the study.
Subject has any skin pathology or condition that could interfere with the evaluation of the test article or requires use of interfering topical, systemic, or surgical therapy.
Subject has any clinically significant medical abnormality or history of chronic disease (cardiovascular, gastrointestinal, neurological, hematopoietic, immunosuppression [HIV], hepatic [Hepatitis B or C], psychological, renal systems, or respiratory), including conditions (e.g., gastrointestinal surgery) that may interfere with the absorption, metabolism, or excretion of investigational product.
Subject has used any of the following topical products on the feet or groin within 4 weeks of Visit 2/Enrollment: antifungals, antibacterials, or corticosteroid therapy.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Subjects will apply at least a total of 4 grams\* of the test article, covering both feet twice daily for 2 weeks

Group II

Active Comparator
Subjects will apply at least a total of 5 grams\* of the test article, covering the interdigital areas of both feet and to the groin once daily for 2 weeks

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Suspended

Site #1

San Diego, United StatesOpen Site #1 in Google Maps
Suspended

Site #5

Thousand Oaks, United States
Suspended

Site #2

Austin, United States
Suspended

Site #3

College Station, United States
Completed5 Study Centers