A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Moderate - 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.

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Key information

Conditions

Tinea Pedis Bacterial Infections and Mycoses Dermatomycoses Foot Dermatoses Foot Diseases Infections Mycoses Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Infectious Skin Manifestations Skin and Connective Tissue Diseases Tinea

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Univ Alabama at Birmingham, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VT-1161

Drug

Placebo

Drug

Primary outcomes

Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population

Time frame: 6 weeks

For this trial, therapeutic cure was defined as clinical AND mycological cure. Clinical cure was defined as the absence of signs and symptoms of clinical disease. Mycological cure was defined as a negative KOH test and a negative fungal culture.

Sponsors and collaborators

Lead sponsor

Viamet

Industry

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Jul 3, 2013
Registry last updated: Aug 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed