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

NCT03897257 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2021-10-28

No results posted yet for this study

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.

Conditions

  • Tinea Pedis

Interventions

DRUG

UHE-103A1 cream

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

DRUG

UHE-103A2 cream

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

DRUG

UHE-103B cream

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

DRUG

UHE-103A1B cream

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

DRUG

UHE-103A2B cream

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

Sponsors & Collaborators

  • Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Marietta Radona, MD · Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-15
Primary Completion
2019-10-21
Completion
2020-05-05
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03897257 on ClinicalTrials.gov