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

Tinea Pedis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05363449
• Other study ID #: 146-9252-102
• Status: Completed
• Phase: Phase 1
• Start date: February 17, 2022
• Est. completion date: November 14, 2023

Study information

• Verified date: April 2024
• Source: Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 14, 2023
• Est. primary completion date: November 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tinea
• Tinea Cruris
• Tinea Pedis

Intervention

Drug:
• UHE-103 Cream
UHE-103 is an investigational combinational therapy containing keratolytic and antifungal
• Naftin (naftifine hydrochloride) Cream
Naftin (naftifine hydrochloride) Cream, 2%. Topical cream containing active drug

Locations

Country	Name	City	State
United States	Site #2	Austin	Texas
United States	Site #3	College Station	Texas
United States	Site #4	Houston	Texas
United States	Site #1	San Diego	California
United States	Site #5	Thousand Oaks	California

Sponsors (1)

Lead Sponsor	Collaborator
Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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