MedTrace Logo

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

NCT05110638 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-06-14

No results posted yet for this study

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.

Conditions

  • Onychomycosis of Toenail

Interventions

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.

Sponsors & Collaborators

  • SATO Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Brent Clary, CCRC · Clinical Research Coordinator J&S Studies, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-13
Primary Completion
2022-12-10
Completion
2023-02-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05110638 on ClinicalTrials.gov