This is a multicenter, open label study designed to evaluate the safety, tolerability, and efficacy of topically administered VTR-297 solution. The efficacy objectives of the study will be assessed using fungal culture testing, Neutral Red Staining (NRS) microscopy examination, and KOH microscopy examination after 4 weeks of treatment with VTR-297.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Topical Study Drug
Vanda Investigational Site
Fremont, California, United States
Vanda Investigational Site
Denver, Colorado, United States
Vanda Investigational Site
New Brighton, Minnesota, United States
Vanda Investigational Site
Pflugerville, Texas, United States
Safety and Tolerability
Subjects will be asked about AEs weekly during the evaluation phase and at every follow-up visit; descriptions of AEs will include, at a minimum: date of onset, date ended, severity, seriousness, relationship to the study drug, and outcome.
Time frame: 24 weeks
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Vanda Investigational Site
Forest, Virginia, United States