Subjects in this open-label study will receive once daily, topical applications of SKX-16 (Luliconazole 10% Solution) in the clinic for 29 days. Subjects will be followed for seven days after the last application (Day 29).~Subjects will be admitted into the study after written informed consent has been obtained and all inclusion/exclusion criteria have been met.
This study is being conducted to determine the pharmacokinetics, systemic exposure, safety and tolerability after daily topical application of SKX-16 (Luliconazole 10% Solution) for duration of 29 days in a maximal use setting in adults with moderate to severe distal subungual onychomycosis of the toenails.