NCT05363449

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2022-02-17
• Primary completion: 2023-11-14
• Completion: 2023-11-14
• First posted: 2022-05-05
• Last updated: 2024-04-10

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study