Safety, Tolerability, and Pharmacokinetics of UHE-103 Cream in Subjects With Tinea Cruris and/or Tinea Pedis
NCT05363449 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2024-04-10
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
Interventions
- DRUG
-
UHE-103 Cream
UHE-103 is an investigational combinational therapy containing keratolytic and antifungal
- DRUG
-
Naftin (naftifine hydrochloride) Cream
Naftin (naftifine hydrochloride) Cream, 2%. Topical cream containing active drug
Sponsors & Collaborators
-
Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Tony Andrasfay · Therapeutics Inc. (CRO)
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-17
- Primary Completion
- 2023-11-14
- Completion
- 2023-11-14
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Pedis
NCT00750139 ·Status: COMPLETED ·Phase: PHASE3
-
BE Study of Naftifine HCL
NCT02633813 ·Status: COMPLETED ·Phase: PHASE3
-
Topical Antifungal Treatment for Tinea Pedis
NCT01396811 ·Status: COMPLETED ·Phase: PHASE3
-
Multicenter Study of the Efficacy and Safety of Luliconazole Cream in Tinea Pedis (Athlete's Foot)
NCT00869336 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis
NCT01289015 ·Status: COMPLETED ·Phase: PHASE3
-
Topical Antifungal Treatment for Tinea Pedis
NCT01396785 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluate the Efficacy and Safety of Tolnaftate Cream in the Treatment of Patients With Fungal Infections
NCT01105013 ·Status: UNKNOWN ·Phase: PHASE3
-
Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis
NCT01290341 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of Efficacy and Safety of Naftin 1% Cream in Adolescent Subjects With Tinea Cruris
NCT01885156 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis
NCT01580891 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis
NCT00835510 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Tinea Pedis
NCT05493488 ·Status: UNKNOWN ·Phase: PHASE2
-
An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis
NCT02466867 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety Study of Iontophoretic Application of Terbinafine Gel in Subjects With Onychomycosis
NCT01080079 ·Status: COMPLETED ·Phase: PHASE2
-
Three-Arm Trial of Novel Treatment for Tinea Pedis
NCT03135912 ·Status: COMPLETED ·Phase: PHASE2
-
Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis
NCT01349998 ·Status: COMPLETED ·Phase: PHASE3
-
A Study Comparing the Efficacy of TA103 and the Placebo Control in the Treatment of Interdigital Tinea Pedis.
NCT04883593 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea Pedis
NCT01433107 ·Status: COMPLETED ·Phase: PHASE3
-
Topical Gel Anti-Fungal Agent for Tinea Unguium
NCT00253305 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams as Compared to Lotrimin Ultra Cream in Patients With Interdigital Tinea Pedis
NCT01119742 ·Status: TERMINATED ·Phase: PHASE1
-
Efficacy and Safety of Product S2G6T-1in Patients With Symptomatic Inflammatory Interdigital Tinea Pedis
NCT02842021 ·Status: TERMINATED ·Phase: PHASE2
-
Topical Antifungal Treatment for Tinea Cruris
NCT01342315 ·Status: COMPLETED ·Phase: PHASE3
-
Pediatric Subjects With Tinea Corporis
NCT02227290 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail
NCT02267356 ·Status: COMPLETED ·Phase: PHASE2
-
Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Cruris
NCT00750152 ·Status: COMPLETED ·Phase: PHASE3