drugset / Trial / NCT05110638

Safety and Tolerability Study of SKX-16 in Subjects With Moderate to Severe Distal Subungual Onychomycosis

NCT05110638

Phase 1 Unknown 20 enrolled SATO Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2021-09-13
Primary completion
2022-12-10
Completion
2023-02-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Luliconazole Small molecule 10 % Topical