Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser

Study Overview
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Brief Summary
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The investigators would like to test the treatment of onychomycosis using a 0.65 millisecond pulsed 1064 nm laser fitted with a special onychomycosis handpiece. The investigators will compare the success rates of those receiving laser treatments with untreated patients. This study will provide a clinical basis for determining the relative effectiveness of an increasingly utilized treatment method.

Detailed Description
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Current antifungal treatments have low cure rates and numerous side effects. A new treatment method, pulsed laser, has been purported to have high rates of treatment in a much shorter time frame than other treatments. While the treatment method has become increasingly popular, studies of its efficacy are few. The investigators hope to learn the cure rate of a novel treatment that is being used by more and more patients. This knowledge will be essential to physicians as they consider employing this new technology in their treatment methods.

Official Title
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Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser

Conditions
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Onychomycosis

Intervention / Treatment
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* Device: Laser Treatment (Pulsed Nd:YAG 1064 nm Laser)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have Onychomycosis on at least one toe. Age 18 or older. Consent to research use of their toenail clippings. Exclusion Criteria: Current immunosuppression (cancer, autoimmune disease) or taking immunosuppressive drugs. Pregnant female. Age 75 or older.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece. nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece. | Device: Laser Treatment (Pulsed Nd:YAG 1064 nm Laser)<br>* 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser<br>|
| No Intervention: Placebo<br>st visit: For the control group, no treatment will be given. nd visit: 2 weeks after initial visit, patient will be seen for second visit | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proximal Clearance of Fungus on Nail | The secondary end point was proximal nail plate clearance as assessed directly by a single study physician, who measured the clinical involvement defined as total length of abnormal nail per each nail of each of the patients' toenails, and confirmed by digital analysis of toenail photographs with ImageJ software. | 1 year |