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

A Multicenter, Randomized, Double-Blinded, Parallel Group Comparison Study of the Safety and Efficacy of UHE-103 in Subjects With Moccasin-Type Tinea Pedis

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.

Study Overview

• Status: Completed
• Conditions: Tinea Pedis
• Intervention / Treatment: Drug: UHE-103A1 cream; Drug: UHE-103A2 cream; Drug: UHE-103B cream; Drug: UHE-103A1B cream; Drug: UHE-103A2B cream

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 2

Contacts and Locations

Study Locations

• Puerto Rico
  • Cidra, Puerto Rico, 00739
    • Site 08
• United States
  • California
    • San Diego, California, United States, 92123
      • Site 03
  • Florida
    • Melbourne, Florida, United States, 32935
      • Site 12
    • Miami, Florida, United States, 33144
      • Site 06
    • North Miami Beach, Florida, United States, 33162
      • Site 09
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Site 07
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Site 11
  • New York
    • Rochester, New York, United States, 14623
      • Site 04
  • Texas
    • Austin, Texas, United States, 78759
      • Site 01
    • Houston, Texas, United States, 77055
      • Site 02
    • San Antonio, Texas, United States, 78229
      • Site 10
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Site 05

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UHE-103A1 cream; Topical cream applied twice daily for 2 weeks.	Drug: UHE-103A1 cream; Investigational mono-therapy cream (containing drug A [low dose]). Drug A is an antifungal agent.
Experimental: UHE-103A2 cream; Topical cream applied twice daily for 2 weeks.	Drug: UHE-103A2 cream; Investigational mono-therapy cream (containing drug A [low dose]). Drug A is an antifungal agent.
Experimental: UHE-103B cream; Topical cream applied twice daily for 2 weeks.	Drug: UHE-103B cream; Comparator mono-therapy cream (containing drug B). Drug B is a keratolytic agent.
Experimental: UHE-103A1B cream; Topical cream applied twice daily for 2 weeks.	Drug: UHE-103A1B cream; Investigational combination-therapy cream (containing drug A [low dose antifungal] + drug B [keratolytic]).
Experimental: UHE-103A2B cream; Topical cream applied twice daily for 2 weeks.	Drug: UHE-103A2B cream; Investigational combination-therapy cream (containing drug A [high dose antifungal] + drug B [keratolytic]).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Day 43

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective treatment	Proportion of subjects with Effective Treatment (negative fungal test & no to mild clinical disease-induced signs and symptoms) at EOS.	Day 43
Mycological Cure	Proportion of subjects with Mycological Cure (negative fungal test) at EOS.	Day 43

Collaborators and Investigators

• Sponsor: Therapeutics, Inc.
• Investigators: Principal Investigator: Marietta Radona, MD, Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2019
• Primary Completion (Actual): October 21, 2019
• Study Completion (Actual): May 5, 2020

Study Registration Dates

• First Submitted: March 28, 2019
• First Submitted That Met QC Criteria: March 28, 2019
• First Posted (Actual): April 1, 2019

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Foot Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Skin Manifestations; Dermatomycoses; Foot Dermatoses; Pruritus; Tinea; Tinea Pedis
• Other Study ID Numbers: 146-9252-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No