A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Moderate - Severe Interdigital Tinea Pedis
| Status: | Completed |
|---|---|
| Conditions: | Podiatry |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/3/2018 |
| Start Date: | August 2013 |
| End Date: | December 2014 |
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets in the Treatment of Patients With Moderate to Severe Interdigital Tinea Pedis
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.
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.
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.
We found this trial at
7
sites
Click here to add this to my saved trials
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
Click here to add this to my saved trials