Safety, Tolerability, and Pharmacokinetics of UHE-103 Cream in Subjects With Tinea Cruris and/or Tinea Pedis
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: UHE-103 Cream 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
UHE-103 is an investigational combinational therapy containing keratolytic and antifungal
|
| Active Comparator: Naftin (naftifine hydrochloride) Cream, 2% 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
Naftin (naftifine hydrochloride) Cream, 2%. Topical cream containing active drug
|
Outcome Measures
Primary Outcome Measures
- Adverse Events (AEs) [Baseline up to Day 16]
Percentage of subjects with any local and systemic AEs defined as "possibly" or "probably" or "definitely" related by the investigator.
- Local Skin Reactions (LSRs) [Day 16]
Percentage of subjects with presence of any of the following LSRs at the end of the study: burning/stinging, edema, and oozing/vesiculation/crusting.
- AUC (0-12 hours) [Day 15]
Defined as the area concentration-time curve (AUC) of the active antifungal drug from time 0 to 12 hours.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is a male or non-pregnant female 18 years of age or older.
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Subject has provided written informed consent.
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Subject has a clinical diagnosis of moccasin-type tinea pedis with at least moderate scaling on at least 1 foot at Visit 1/Screening;
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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.
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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:
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Subject is pregnant, lactating, or is planning to become pregnant during the study.
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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.
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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.
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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.
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Subject has applied any topical naftifine products to any part of their body within 4 weeks of Visit 2/Enrollment.
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Subject has used topical keratolytics (e.g., urea, ammonium lactate, salicylic acid) on the feet or groin within 1 week of Visit 2/Enrollment.
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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.
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Subject has received systemic antifungal therapy within 8 weeks or 5 half lives of the antifungal (whichever is longer) of Visit 2/Enrollment.
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Subject is currently enrolled in an investigational drug, biologic, or device study.
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Subject has previously been enrolled in a study for UHE-103.
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Subject has used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to Visit 2/Enrollment.
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Subject has a history of sensitivity to any of the ingredients in the test articles.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site #1 | San Diego | California | United States | 92123 |
| 2 | Site #5 | Thousand Oaks | California | United States | 91320 |
| 3 | Site #2 | Austin | Texas | United States | 78759 |
| 4 | Site #3 | College Station | Texas | United States | 77845 |
| 5 | Site #4 | Houston | Texas | United States | 77055 |
Sponsors and Collaborators
- Therapeutics, Inc.
Investigators
- Study Director: Tony Andrasfay, Therapeutics Inc. (CRO)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 146-9252-102