A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Moderate - Severe Interdigital Tinea Pedis

Tinea Pedis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01891305
• Other study ID #: VMT-VT-1161-CL-003
• Status: Completed
• Phase: Phase 2
• Start date: August 2013
• Est. completion date: December 2014

Study information

• Verified date: July 2018
• Source: Viamet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tinea
• Tinea Pedis

Intervention

Drug:
• VT-1161

• placebo

Locations

Country	Name	City	State
United States	Univ Alabama at Birmingham	Birmingham	Alabama
United States	J&S Studies, Inc.	College Station	Texas
United States	Florida Academic Dermatology Center	Miami	Florida
United States	FXM Research	Miramar	Florida
United States	Pariser Dermatology Specialists	Norfolk	Virginia
United States	Oregon Dermatology & Research Center	Portland	Oregon
United States	Wake Research Associates	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Viamet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population	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.	6 weeks