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Completed

NCT Number: NCT03897257

A Comparison Study of UHE-103 Cream 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.

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Key information

Conditions

Tinea Pedis Bacterial Infections and Mycoses Dermatomycoses Foot Dermatoses Foot Diseases Infections Mycoses Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Infectious Skin Manifestations Skin and Connective Tissue Diseases Tinea

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 08, Cidra, Puerto Rico

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

UHE-103A1 cream

Drug

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

UHE-103A2 cream

Drug

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

UHE-103B cream

Drug

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

UHE-103A1B cream

Drug

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

UHE-103A2B cream

Drug

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

Primary outcomes

  1. Complete Cure at End of Study

    Time frame: Day 43

    Proportion of subjects with Complete Cure (negative fungal test & no clinical disease-induced signs and symptoms) at end of study (EOS).

Secondary outcomes

  1. Effective treatment

    Time frame: Day 43

    Proportion of subjects with Effective Treatment (negative fungal test & no to mild clinical disease-induced signs and symptoms) at EOS.

  2. Mycological Cure

    Time frame: Day 43

    Proportion of subjects with Mycological Cure (negative fungal test) at EOS.

Sponsors and collaborators

Lead sponsor

Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Apr 1, 2019
Registry last updated
Oct 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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