Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05363449
Other study ID # 146-9252-102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05493488 - A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Tinea Pedis Phase 2
Completed NCT04883593 - A Study Comparing the Efficacy of TA103 and the Placebo Control in the Treatment of Interdigital Tinea Pedis. Early Phase 1
Terminated NCT02842021 - Efficacy and Safety of Product S2G6T-1in Patients With Symptomatic Inflammatory Interdigital Tinea Pedis Phase 2
Completed NCT01712360 - Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis Phase 4
Completed NCT00781664 - Cumulative Irritation Test Phase 1
Completed NCT03676686 - Study With Nåva Foot Cream in Patients With Tinea Pedis Interdigitalis N/A
Completed NCT01519752 - A Therapeutic Equivalence Study of Two Oxiconazole Nitrate Topical Cream Treatments for Patients With Tinea Pedis Phase 1
Completed NCT03320486 - Non-inferiority Trial of Dapaconazole Versus Ketoconazole Phase 3
Completed NCT01580891 - Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis Phase 1
Completed NCT01349998 - Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis Phase 3
Completed NCT01353976 - Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis Phase 3
Completed NCT04265521 - Study With BioCool Footcare in Subjects With Tinea Pedis Interdigitalis and Heel Cracks, Calluses and/or Dry Feet N/A
Completed NCT02633813 - BE Study of Naftifine HCL Phase 3
Recruiting NCT00856596 - Once a Day Topical Treatment for Athlete's Foot Fungus Inbetween the Toes in Males and Females Phase 3
Completed NCT00869336 - Multicenter Study of the Efficacy and Safety of Luliconazole Cream in Tinea Pedis (Athlete's Foot) Phase 2
Completed NCT00768599 - A Study of Econazole Foam 1% in Athlete's Foot Phase 2
Recruiting NCT00233493 - Spread of Dermatophytes Among Families N/A
Completed NCT03897257 - A Comparison Study of UHE-103 Cream in Subjects With Moccasin Type Tinea Pedis Phase 2
Completed NCT03129321 - Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis Phase 3
Completed NCT02335255 - Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis Phase 1