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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing a new therapy light to see if it is safe and effective.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

An increase in healthy new nail growth free of fungal infection ("clear nail"), 6-12 months post-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 / 4Eligibility criteria met

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Who is running the clinical trial?

ToeFX Inc.Lead Sponsor

Alexander Rabinovich, MDPrincipal InvestigatorMcMaster University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for this research endeavor restricted to those older than eighty-five?

"The cut-off age to be eligible for this trial is 18 years old while the upper limit has been set at 75."

Answered by AI

Are new participants currently being accepted for enrolment in this experiment?

"Affirmative, clinicaltrials.gov verifies that enrolment is currently underway for this medical investigation which was first posted on February 19th 2020 and most recently updated December 16th 2021. An aggregate of 100 participants need to be recruited at one research site."

Answered by AI

What is the aggregate size of this research project's subject population?

"Affirmative. Clinicaltrials.gov's records display that this research undertaking is currently recruiting participants, having been first made available on February 19th 2020 and most recently revised on December 16th 2021. This investigation needs to identify 100 volunteers from a single location."

Answered by AI

Is there an opportunity for me to join this research project?

"This experiment is seeking 100 individuals aged 18 to 75 with onychomycosis of the great toe. Aspiring participants must adhere to specific criteria, such as not applying polish or medication onto their toes during treatment and refraining from using topical steroids/antifungals and systemic antifungals for the duration of the trial. Furthermore, any candidates must have mild-to-moderate DSO covering 20% - 50% of their target toenail without dermatophytomas or lunula involvement in order to qualify."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Light Therapy for Onychomycosis Study

2020. "Light Therapy for Onychomycosis Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05139888.