CompletedPhase 2

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

United States, Puerto Rico240 participantsStarted 2019-03-15

Plain-language 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.

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or non-pregnant female, 16 years of age or older. * Clinical diagnosis of moccasin type tinea pedis * Microscopic evidence (positive KOH) of the presence of fungi * Provided written informed consent/assent * In general good health Exclusion Criteria: * Pregnant or lactating or planning to get pregnant while on the study * Has concurrent tinea infection (e.g., tinea versicolor, tinea cruris) * Other skin disease which might interfere with the evaluation of tinea pedis * History of diabetes mellitus or is immunocompromised * Currently enrolled in an investigational drug or device study * Used an investigational drug or investigational device treatment within 30 days prior to Visit 1 (Study Day 1)/Baseline Other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Complete Cure at End of Study

Timeframe: Day 43

Trial details

NCT IDNCT03897257

SponsorTherapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-10-21

View on ClinicalTrials.gov More Tinea Pedis trials

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.