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

Study Overview
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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).

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

Conditions
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Tinea Pedis

Intervention / Treatment
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* Drug: UHE-103A1 cream
* Drug: UHE-103A2 cream
* Drug: UHE-103B cream
* Drug: UHE-103A1B cream
* Drug: UHE-103A2B cream


Participation Criteria
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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 Other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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)
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |