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

Phase 2

Completed

• Conditions: Tinea Pedis
• Interventions: Drug: placebo; Drug: VT-1161

• Registration Number: NCT01891305
• Lead Sponsor: Viamet

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-03
• Study Start: 2013-08
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2018-06-06
• Results First Submitted QC: 2018-06-06
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-05
• Results First Posted: 2018-07-06
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Matching placebo	placebo	-
VT-1161 200/50mg	VT-1161	-
VT-1161 600/150mg	VT-1161	-
VT-1161 1200/300mg	VT-1161	-

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population	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.

Trial Locations

Locations (7)

Oregon Dermatology & Research Center; 🇺🇸 Portland, Oregon, United States

FXM Research; 🇺🇸 Miramar, Florida, United States

Wake Research Associates; 🇺🇸 Raleigh, North Carolina, United States

Pariser Dermatology Specialists; 🇺🇸 Norfolk, Virginia, United States

Univ Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Florida Academic Dermatology Center; 🇺🇸 Miami, Florida, United States

J&S Studies, Inc.; 🇺🇸 College Station, Texas, United States