SATO Pharmaceutical Co., Ltd.
This is a parallel group, double blind, vehicle-controlled study in which SKX-16 or vehicle (2:1 randomization) is applied once a day for 52 weeks to all affected toenails to participants with mild to moderate distal subungual onychomycosis (DSO) of the toenails involving between 20 to 50% of at least one great toenail at Screening.
Inclusion Criteria: * Participant is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures. * Male or female participant of any race aged 18 to 70 years, inclusive, at the time of consent. * Participants with a clinical diagnosis of DSO, involving 20%-50% of at least one of the great toenails at screening. * Participants must have no more than 5 toes with suspected presence of onychomycosis (ie, no more than a total of 5 infected toenails, including ≤3 non-great toenails and up to 2 great toenails) at screening.…
Applied topically once daily for 52 weeks to all affected toenails identified by the investigator, followed by a Week 56 follow-up visit.
Applied topically once daily for 52 weeks to all affected toenails identified by the investigator, followed by a Week 56 follow-up visit, under the same conditions as the active arm.