Clinical trial NCT05363449: Safety, Tolerability, and Pharmacokinetics of UHE-103 Cream in Subjects With Tinea Cruris and/or Tinea Pedis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tinea Cruris
Tinea Pedis
Lead sponsor: Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-05
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse Events (AEs)
timeFrame: Baseline up to Day 16
measure: Local Skin Reactions (LSRs)
timeFrame: Day 16
measure: AUC (0-12 hours)
timeFrame: Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Site #1
state: California
city: Thousand Oaks
country: United States
facility: Site #5
state: California
city: Austin
country: United States
facility: Site #2
state: Texas
city: College Station
country: United States
facility: Site #3
state: Texas
city: Houston
country: United States
facility: Site #4
state: Texas
Study officials:
affiliation: Therapeutics Inc. (CRO)
name: Tony Andrasfay
role: STUDY_DIRECTOR
References: