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Antifungal

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

Phase 1
Waitlist Available
Research Sponsored by SATO Pharmaceutical Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 days
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a medicated solution with 10% Luliconazole applied daily for about a month in adults with a toenail fungal infection. The solution aims to kill the fungus causing the infection. Luliconazole is a new treatment being developed in the USA for skin and nail infections.

Eligible Conditions
  • Toenail Fungus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PK parameters for the systemic absorption of luliconazole - AUC0-24h
PK parameters for the systemic absorption of luliconazole - AUC0-∞
PK parameters for the systemic absorption of luliconazole - Cmax
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SKX-16 (Luliconazole 10% Solution)Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

SATO Pharmaceutical Co., Ltd.Lead Sponsor
1 Previous Clinical Trials
134 Total Patients Enrolled
Brent Clary, CCRCStudy ChairClinical Research Coordinator J&S Studies, Inc.
~5 spots leftby Dec 2025
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