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

NCT05363449 | Completed Phase 1 FDA Drug

• 1 other identifier: 146-9252-102
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 5

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

Conditions

Tinea Cruris; Tinea Pedis

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

UHE-103 Cream

EXPERIMENTAL

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

Naftin (naftifine hydrochloride) Cream, 2%

ACTIVE COMPARATOR

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

Interventions

UHE-103 Cream DRUG

UHE-103 is an investigational combinational therapy containing keratolytic and antifungal

UHE-103 Cream

Naftin (naftifine hydrochloride) Cream DRUG

Naftin (naftifine hydrochloride) Cream, 2%. Topical cream containing active drug

Naftin (naftifine hydrochloride) Cream, 2%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Therapeutics, Inc.: lead

Study Sites (5)

Site #1

San Diego, California, 92123, United States

Location

Site #5

Thousand Oaks, California, 91320, United States

Location

Site #2

Austin, Texas, 78759, United States

Location

Site #3

College Station, Texas, 77845, United States

Location

Site #4

Houston, Texas, 77055, United States

Location

MeSH Terms

Conditions

Tinea Cruris; Tinea Pedis

Interventions

naftifine

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Intertrigo; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Foot Dermatoses; Foot Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tony Andrasfay

  Therapeutics Inc. (CRO)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: May 5, 2022
• Study Start: February 17, 2022
• Primary Completion: November 14, 2023
• Study Completion: November 14, 2023
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)