What side effects are associated with this type of intervention?

Common treatments for toenail fungus include oral antifungal medications, topical antifungal treatments, and light-based therapies such as laser treatment. Oral antifungal medications can cause side effects like gastrointestinal issues, liver damage, and skin rashes. Topical treatments may lead to local irritation and redness. Light-based therapies, including laser treatments, are generally well-tolerated but can cause mild pain, temporary nail discoloration, and, in rare cases, burns or blistering.

What prior FDA approvals exist?

The FDA has approved several treatments for toenail fungus (onychomycosis), including oral antifungal medications like terbinafine (Lamisil) and itraconazole (Sporanox), as well as topical treatments such as efinaconazole (Jublia) and tavaborole (Kerydin). Additionally, laser treatments, which use light to target the fungus, have also been approved. These laser therapies are similar to the light therapy being studied in the ToeFX Therapy Light trial, as they both utilize light to treat the fungal infection.

What other types of research exist?

Promising novel alternatives to ToeFX Therapy Light for treating toenail fungus include the combination of CO2 laser therapy with topical agents such as luliconazole, tioconazole, terbinafine, and tazarotene. This combined approach has been shown to significantly increase efficacy and patient satisfaction compared to topical treatments alone.

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Light Therapy

Light Therapy for Toenail Fungus

N/A

Waitlist Available

Led By Alexander Rabinovich, MD

Research Sponsored by ToeFX Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are willing to refrain from using topical steroids or topical antifungals on toenails or the skin immediately adjacent to the toenails or systemic antifungals for the duration of the study.

Exhibit positive mycology results (i.e., KOH test and culture of a dermatophyte) from the target great toenail, confirming common dermatophytes such as T. rubrum.

Must not have

Persons who have any known immunodeficiency or history of malignancy in the last 4 years, excluding nonmelanoma skin cancer.

Females who are pregnant, plan to become pregnant during the study, or are nursing a child.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the safety and effectiveness of the ToeFX Therapy Light, a special light treatment for toenail fungus, in 100 patients. The light is believed to kill the fungus causing the infection, offering a potential new solution for those who haven't had success with other treatments.

Who is the study for?

This trial is for adults with mild to moderate toenail fungus on at least one big toe, confirmed by a positive mycology test. Participants must not use nail polish or other medications on the affected nails during the study and should not have used antifungal treatments recently. Pregnant women, nursing mothers, smokers, and those with certain health conditions or allergies are excluded.

What is being tested?

The ToeFX Therapy Light's safety and effectiveness in treating toenail fungus are being tested. The study compares two types of light therapy: one using only red light and another combining red and blue light wavelengths.

What are the potential side effects?

As this is a pilot study primarily focused on light therapy for toenail fungus, specific side effects are not detailed but may include skin irritation around the treated area or an allergic reaction to the treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree not to use any nail or skin steroids, antifungals, or systemic antifungals during the study.

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My toenail fungus test for common dermatophytes like T. rubrum was positive.

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I have a mild to moderate nail fungus on my big toe, affecting 20% to 50% of the nail without affecting the nail root.

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I am willing to sign a consent form in English for the trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had cancer (except for nonmelanoma skin cancer) or an immune deficiency in the last 4 years.

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I am not pregnant, planning to become pregnant, or nursing.

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I do not have G6PD deficiency or allergies to methylene blue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

An increase in healthy new nail growth free of fungal infection ("clear nail"), 6-12 months post-treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Single wavelength light (red) onlyExperimental Treatment1 Intervention

Arm 1 will test the core technology of the ToeFX system; this study reproduces methods well-described in the literature. After application of the formulation, nails affected by onychomycosis are exposed to red light at a wavelength of 630-660 nm intensity of 200 mW/cm2.

Group II: Dual wavelength light (red/blue)Experimental Treatment1 Intervention

Some research has shown that exposure to mild blue light can have anti-inflammatory effects that would improve patient onychomycosis outcomes. We will assess whether inclusion of blue light in the protocol affects the clinical outcome.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Light therapy, such as the ToeFX Therapy Light, works by using specific wavelengths of light to penetrate the nail and kill the fungal cells by disrupting their cellular structures. This method is non-invasive and can be effective without the side effects associated with systemic treatments. Topical antifungal agents, like terbinafine and ciclopirox, work by inhibiting the synthesis of ergosterol, an essential component of fungal cell membranes, leading to cell death. Systemic antifungal medications, such as itraconazole, work similarly but are taken orally and can treat more severe or widespread infections. These treatments are crucial for patients as they offer various options depending on the severity of the infection and patient preferences, potentially leading to better adherence and outcomes.

Efficacy of laser therapy combined with topical antifungal agents for onychomycosis: a systematic review and meta-analysis of randomised controlled trials.Topical and device-based treatments for fungal infections of the toenails.