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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Univ Alabama at Birmingham
Birmingham, Alabama, United States
Florida Academic Dermatology Center
Miami, Florida, United States
FXM Research
Miramar, Florida, United States
Wake Research Associates
Raleigh, North Carolina, United States
Oregon Dermatology & Research Center
Portland, Oregon, United States
J&S Studies, Inc.
College Station, Texas, United States
Pariser Dermatology Specialists
Norfolk, Virginia, United States
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.
Time frame: 6 weeks
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