Safety, Tolerability, and Pharmacokinetics of UHE-103 Cream in Subjects With Tinea Cruris and/or Tinea Pedis

Study Overview
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Brief Summary
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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 Title
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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

Conditions
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Tinea Cruris, Tinea Pedis

Intervention / Treatment
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* Drug: UHE-103 Cream
* Drug: Naftin (naftifine hydrochloride) Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study. Exclusion Criteria: 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. Subject has applied any topical naftifine products to any part of their body within 4 weeks of Visit 2/Enrollment. Subject has used topical keratolytics (e.g., urea, ammonium lactate, salicylic acid) on the feet or groin within 1 week of Visit 2/Enrollment. Subject has used any other topical products on the feet or groin within 24 hours of Visit 2/Enrollment including, but not limited to non-medicated moisturizers, antipruritics, analgesics, anesthetics, etc. Subject has received systemic antifungal therapy within 8 weeks or 5 half lives of the antifungal (whichever is longer) of Visit 2/Enrollment. Subject is currently enrolled in an investigational drug, biologic, or device study. Subject has previously been enrolled in a study for UHE-103. Subject has used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to Visit 2/Enrollment. Subject has a history of sensitivity to any of the ingredients in the test articles.

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UHE-103 Cream<br>Subjects will apply at least a total of 4 grams* of the test article, covering both feet twice daily for 2 weeks | Drug: UHE-103 Cream<br>* UHE-103 is an investigational combinational therapy containing keratolytic and antifungal<br>|
| Active Comparator: Naftin (naftifine hydrochloride) Cream, 2%<br>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 | Drug: Naftin (naftifine hydrochloride) Cream<br>* Naftin (naftifine hydrochloride) Cream, 2%. Topical cream containing active drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AEs) | Percentage of subjects with any local and systemic AEs defined as possibly or probably or definitely related by the investigator. | Baseline up to Day 16 | 
| Local Skin Reactions (LSRs) | Percentage of subjects with presence of any of the following LSRs at the end of the study: burning/stinging, edema, and oozing/vesiculation/crusting. | Day 16 | 
| AUC (0-12 hours) | Defined as the area concentration-time curve (AUC) of the active antifungal drug from time 0 to 12 hours. | Day 15 |