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SKX-16 for Toenail Fungus

Not yet recruiting at 5 trial locations
MA
Overseen ByMehria Afzal Patient Recruitment and Site Engagement Specialist
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: SATO Pharmaceutical Co., Ltd.
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a parallel group, double blind, vehicle-controlled study in which SKX-16 or vehicle (2:1 randomization) is applied once a day for 52 weeks to all affected toenails to participants with mild to moderate distal subungual onychomycosis (DSO) of the toenails involving between 20 to 50% of at least one great toenail at Screening.

Are You a Good Fit for This Trial?

This trial is for people with mild to moderate toenail fungus (onychomycosis) affecting 20–50% of at least one big toenail. Participants should not have severe cases or other major health issues that could interfere with the study.

Inclusion Criteria

Clinical judgment supports that the historical growth rate of the target great toenail will permit monthly toenail clipping during the study
Participant must be willing and able to comply with all study procedures and be available for the duration of the study
I am willing and able to give informed consent for the study.
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Exclusion Criteria

Participant has any clinically significant medical condition or physical/laboratory/vital signs abnormality that would put the participant at undue risk or interfere with interpretation of study results
Participant is known to have immune deficiency or is immunocompromised
I am currently pregnant, breastfeeding, or planning to become pregnant.
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What Are the Treatments Tested in This Trial?

Interventions

  • SKX-16 (Luliconazole 10% Solution)

Trial Overview

The study compares a new topical treatment, SKX-16 (Luliconazole 10% solution), applied daily to affected toenails, against a placebo solution over 52 weeks. Participants are randomly assigned to either group in a double-blind manner.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Active ArmExperimental Treatment1 Intervention
Group II: Vehicle ArmPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

SATO Pharmaceutical Co., Ltd.

Lead Sponsor

Trials
2
Recruited
150+

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