NCT05110638

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

A Phase 1, Open-Label Study Evaluating the Pharmacokinetics, Absorption, Safety and Tolerability With Maximal Use of SKX-16 (Luliconazole 10% Solution) in Subjects With Moderate to Severe Distal Subungual Onychomycosis

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: SATO Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Onychomycosis of Toenail

Interventions

Type	Name	Description
DRUG	SKX-16 (Luliconazole 10% Solution)	SKX-16 (Luliconazole 10% Solution) will be applied to each toenail and periungual areas once daily for 29 days such that there is sufficient quantity of solution to treat all toenails. All ten toes will be treated regardless of whether affected. The applications will occur in the clinic and be applied by study personnel. The nails will remain exposed until the applied solution dries.

Timeline

• Start date: 2021-09-13
• Primary completion: 2022-12-10
• Completion: 2023-02-22
• First posted: 2021-11-08
• Last updated: 2022-06-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study