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

Overseen By Ritu Verma

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: SATO Pharmaceutical Co., Ltd.

Must not be taking: Systemic antifungals, Corticosteroids

Disqualifiers: Cardiac disease, Diabetes, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

Duration: 4 weeks

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to stop using certain medications before starting. You must not use topical antifungals, corticosteroids, or systemic antifungals for a specified period before the trial begins. Check with the study team to see if your current medications are affected.

How does the drug SKX-16 (Luliconazole 10% Solution) differ from other treatments for fungal infections?

Luliconazole 10% Solution is unique because it is a potent antifungal that can penetrate the nail plate to treat onychomycosis (nail fungus) effectively. It has a strong fungicidal activity similar to terbinafine and is known for its excellent local tolerability and lack of systemic side effects. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Brent Clary, CCRC

Principal Investigator

Clinical Research Coordinator J&S Studies, Inc.

Eligibility Criteria

Inclusion Criteria

You are eligible for this study if you are between the ages of 18 and 65 inclusive.

Subjects with a clinical diagnosis of distal subungual onychomycosis involving both great toenails and ≥ 50% of at least one of the great toenails, as determined by visual inspection after the nail is trimmed.

Subjects demonstrate ability and willingness to sign a written informed consent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive once daily, topical applications of SKX-16 (Luliconazole 10% Solution) in the clinic

4 weeks

29 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

Treatment Details

Interventions

• SKX-16 (Luliconazole 10% Solution)

Participant Groups

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

Who Is Running the Clinical Trial?

SATO Pharmaceutical Co., Ltd.

Lead Sponsor

Trials

2

Recruited

150+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Luliconazole: a review of a new antifungal agent for the topical treatment of onychomycosis. [2018]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Luliconazole for the treatment of fungal infections: an evidence-based review. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

A sensitive and rapid bioanalytical method for the quantitative determination of luliconazole in rabbit eye tissues using UPLC-MS/MS assay. [2022]

4. Egypt pubmed.ncbi.nlm.nih.gov

Formulation and Development of a Water-in-Oil Emulsion-Based Luliconazole Cream: In Vitro Characterization and Analytical Method Validation by RP-HPLC. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Antifungal susceptibility of dermatophytes from racehorses in Japan. [2022]