Diode Laser Treatment of Onychomycosis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the V-Raser diode laser system with investigational Nail Fungus Handpiece in the treatment of onychomycosis.

Official Title
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Study of the V-Raser Diode Laser System in the Treatment of Onychomycosis

Conditions
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Onychomycosis

Intervention / Treatment
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* Device: Diode Laser Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed subungual onychomycosis in a great toe that does not extend to the eponychium Fitzpatrick Skin Type I-IV Written and verbal informed consent Able to comply with study instructions and to return to the clinic for required visits Agrees to refrain from other active topical, laser or light-based treatment to the great toes Agrees to the use of Naftin Gel between the toes to prevent/control tinea pedis Exclusion Criteria: Pregnancy, breastfeeding or planning to become pregnant History of cutaneous photosensitivity, porphyria and hypersensitivity to porphyrins or photodermatoses Any skin pathology or condition that could interfere with the evaluation or that requires the use of interfering topical or systemic therapy Coagulation disorder or current use of anti-coagulation medication (including aspirin use of greater than 81 mg per day) Any condition which, in the investigator's opinion, would make it unsafe for the subject to participate Enrolled in an investigational drug or device trial, or has been treated with an investigational device or received an investigational drug within 30 days Oral Lamisil within 1 year, Sporanox or over-the-counter topicals within 1 month, or other prescription anti-fungal medications or topicals within 6 months Evidence of diabetic neuropathy or peripheral vascular disease related to diabetes, or a loss of protective sensation in the affected foot Psoriasis, lichen planus, infection involving the lunula, prior surgical treatment of the affected great toe within 1 year, or a history of trauma to the affected great toe Immunocompromised status, or with existing (or history of) cancer/skin malignancy Distal nail thickness of greater than 2mm in the affected great toenail

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Even though this study has recruited more than 10 participants, it is a feasibility study, designed to test the prototype rather than measuring health outcomes. It is to confirm the operating specifications before beginning a full clinical trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diode Laser Treatment<br> | Device: Diode Laser Treatment<br>* Laser treatment once every 6 weeks, for a total of 4 treatment sessions<br>* Other names: V-Raser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Clear Nail Growth from Baseline in mm or as measurement of total area of involvement | Amount of lesion-free toenail growth (mm or total area of involvement) from Baseline, as judged by computer software analysis of photos. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Onychomycosis, Toenail Fungus