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

Onychomycosis of Toenail Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05110638
Study type Interventional
Source SATO Pharmaceutical Co., Ltd.
Contact
Status Active, not recruiting
Phase Phase 1
Start date September 13, 2021
Completion date February 22, 2023
View Details
See also
  Status Clinical Trial Phase
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