A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Moderate - Severe In… (NCT01891305) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Moderate - Severe Interdigital Tinea Pedis
United States50 participantsStarted 2013-08
Plain-language summary
The purpose of this study is to determine if the novel oral agent VT-1161 is safe and effective in treating patients with moderate - severe tinea pedis (also referred to as athletes foot). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this results in many of the side effects associated with the azole antifungals. The safety profile of the class similarly limits use in chronic treatment of non-life-threatening fungal infections. A safer antifungal drug would improve treatment options for infections seen in otherwise healthy individuals where significant side-effect risks are unacceptable.
Who can participate
Age range
18 Years – 65 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.
Key Inclusion Criteria:
* Healthy male and non-pregnant female patients ≥18 years and \<65 years
* Clinical diagnosis of tinea pedis
* Positive baseline KOH
* Clinical signs and symptoms score of the target lesion is at least 6, including a minimum score of at least 2 for erythema AND a minimum score of 2 for either scaling or pruritus (on a scale of 0-3, where 2 indicates moderate severity)
* Patients must be able to swallow capsules intact
* Use acceptable birth control methods
Key Exclusion Criteria:
* Major organ system disease or clinical infection
* Poorly controlled diabetes mellitus
* Pregnant or lactating
* Confluent, diffuse moccasin-type tinea pedis
* Presence of onychomycosis involving a) more than 5 toe nails, b) any fingernail
* Recent use of topical corticosteroids, topical antibiotics, or topical antifungal therapy to the foot
* Recent use of systemic corticosteroids or antifungal therapy
* Known(HIV)infection
* Known significant hepatic, or hematologic impairment .Requirement for treatment with concomitant antimicrobial or systemic antifungal therapy for any reason.
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
1
Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population