NCT03897257

A Comparison Study of UHE-103 Cream in Subjects With Moccasin Type Tinea Pedis

A Multicenter, Randomized, Double-Blinded, Parallel Group Comparison Study of the Safety and Efficacy of UHE-103 in Subjects With Moccasin-Type Tinea Pedis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Therapeutics, Inc. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The study is being done to determine and compare the safety and effectiveness of an investigational combination therapy (low and high concentrations) versus mono-therapy (low and high concentrations) or mono-therapy (fixed concentration) in subjects with moccasin type tinea pedis.

Detailed description

UHE-103 cream is an investigational combination drug to treat moccasin type tinea pedis, a fungal infection that affects the feet and toes. Eligible subjects will be assigned to one of the 5 possible treatment groups and participate for a total of 6 weeks. Subjects will apply their assigned test drug twice daily for 2 weeks. Each subject will then be assessed for safety and efficacy at week 4 and week 6. There will be a total of 5 clinic visits: 1 screening/baseline visit (Day 1), 2 treatment visits (Days 8 and 15), and 2 follow-up visits (Days 29 and 43).

Conditions

• Tinea Pedis

Interventions

Type	Name	Description
DRUG	UHE-103A1 cream	Investigational mono-therapy cream (containing drug A \[low dose\]). Drug A is an antifungal agent.
DRUG	UHE-103A2 cream	Investigational mono-therapy cream (containing drug A \[low dose\]). Drug A is an antifungal agent.
DRUG	UHE-103B cream	Comparator mono-therapy cream (containing drug B). Drug B is a keratolytic agent.
DRUG	UHE-103A1B cream	Investigational combination-therapy cream (containing drug A \[low dose antifungal\] + drug B \[keratolytic\]).
DRUG	UHE-103A2B cream	Investigational combination-therapy cream (containing drug A \[high dose antifungal\] + drug B \[keratolytic\]).

Timeline

• Start date: 2019-03-15
• Primary completion: 2019-10-21
• Completion: 2020-05-05
• First posted: 2019-04-01
• Last updated: 2021-10-28

Locations

12 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study