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

Phase 1

Completed

• Conditions: Tinea Cruris; Tinea Pedis
• Interventions: Drug: Naftin (naftifine hydrochloride) Cream; Drug: UHE-103 Cream

• Registration Number: NCT05363449
• Lead Sponsor: Therapeutics, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-17
• Study First Submitted: 2022-03-10
• Study First Submitted QC: 2022-05-02
• Study First Posted: 2022-05-05
• Primary Completion: 2023-11-14
• Study Completion: 2023-11-14
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Subject is a male or non-pregnant female 18 years of age or older.
2. Subject has provided written informed consent.
3. Subject has a clinical diagnosis of moccasin-type tinea pedis with at least moderate scaling on at least 1 foot at Visit 1/Screening;
4. 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.
5. 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

1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
2. 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.
3. 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.
4. 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.
5. Subject has applied any topical naftifine products to any part of their body within 4 weeks of Visit 2/Enrollment.
6. Subject has used topical keratolytics (e.g., urea, ammonium lactate, salicylic acid) on the feet or groin within 1 week of Visit 2/Enrollment.
7. 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.
8. Subject has received systemic antifungal therapy within 8 weeks or 5 half lives of the antifungal (whichever is longer) of Visit 2/Enrollment.
9. Subject is currently enrolled in an investigational drug, biologic, or device study.
10. Subject has previously been enrolled in a study for UHE-103.
11. Subject has used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to Visit 2/Enrollment.
12. Subject has a history of sensitivity to any of the ingredients in the test articles.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naftin (naftifine hydrochloride) Cream, 2%	Naftin (naftifine hydrochloride) Cream	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
UHE-103 Cream	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

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (5)

Site #4; 🇺🇸 Houston, Texas, United States

Site #1; 🇺🇸 San Diego, California, United States

Site #5; 🇺🇸 Thousand Oaks, California, United States

Site #3; 🇺🇸 College Station, Texas, United States

Site #2; 🇺🇸 Austin, Texas, United States