SKX-16 for Toenail Fungus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new topical treatment called SKX-16 (Luliconazole 10% Solution) to assess its safety and tolerability for individuals with moderate to severe toenail fungus. The goal is to understand the body's absorption of the treatment and ensure its safe use. Individuals with toenail fungus on both big toes, affecting at least half of one big toenail and at least four other toenails, might be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.
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.
Is there any evidence suggesting that SKX-16 (Luliconazole 10% Solution) is likely to be safe for humans?
Research shows that Luliconazole, the main ingredient in SKX-16, is generally safe and easy to use. One study found that participants who applied Luliconazole 10% Solution to their toenails daily for 29 days experienced no major side effects, indicating it was safe and well-tolerated.
SKX-16 remains in the early stages of testing. These tests aim to gather more information about its safety and how the body processes it. Although Luliconazole is used in other treatments, this specific version, SKX-16, is under study to ensure its safety for this particular use.12345Why do researchers think this study treatment might be promising?
Unlike traditional treatments for distal subungual onychomycosis, which often involve oral antifungal medications or topical treatments with lower concentrations, SKX-16 uses a 10% luliconazole solution. This higher concentration of luliconazole could potentially offer stronger antifungal activity directly at the site of infection. Researchers are excited about SKX-16 because it may provide a more effective solution with fewer systemic side effects compared to oral medications, which can sometimes affect the liver or interact with other drugs. Additionally, using a topical solution allows for targeted treatment, reducing the risk of whole-body side effects.
What evidence suggests that SKX-16 might be an effective treatment for onychomycosis?
Research has shown that Luliconazole 10% Solution effectively treats toenail fungus, also known as onychomycosis. Studies have found that this antifungal treatment penetrates the nail and significantly improves infected nails. In trials, participants who applied this solution daily to their infected toenails experienced significant improvements, and the treatment proved easy to use. The solution's ability to directly target the fungus makes it a promising option for those with moderate to severe toenail infections.23467
Who Is on the Research Team?
Brent Clary, CCRC
Principal Investigator
Clinical Research Coordinator J&S Studies, Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive once daily, topical applications of SKX-16 (Luliconazole 10% Solution) in the clinic
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- SKX-16 (Luliconazole 10% Solution)
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
SATO Pharmaceutical Co., Ltd.
Lead Sponsor
Citations
Safety and Efficacy of Luliconazole Solution, 10% in ...
The purpose of this study is to determine the safety and efficacy of a topical antifungal formulation, Luliconazole Solution, 10%, in the treatment of adults ...
A blinded review of the ongoing SOLUTION study, a phase ...
A blinded review of the ongoing SOLUTION study, a phase 2b/3 study of 2 dosing regimens of a novel 10% luliconazole solution in patients with onychomycosis.
Safety and Tolerability of Luliconazole Solution 10-Percent ...
Luliconazole, when applied once daily to all 10 fungus-infected toenails for 29 days, is generally safe and well tolerated and results in significant ...
Safety and Tolerability Study of SKX-16 in Subjects With ...
This study is being conducted to determine the pharmacokinetics, systemic exposure, safety and tolerability after daily topical application of SKX-16 ...
Safety and Tolerability Study of SKX-16 in Subjects With ...
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 ...
Safety Data Sheet
Evaporation rate. Not applicable. 10 Stability and reactivity. · Reactivity No further relevant information available. · Chemical stability. · ...
Luliconazole - Safety Data Sheet
Avoid contacting with skin and eye. Use personal protective equipment.Wear chemical impermeable gloves. Ensure adequate ventilation.Remove all sources of ...
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