PinPointe FootLaser for the Treatment of Onychomycosis

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of the PathoLase FootLaser treatment of infected toenails.

Detailed Description
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The study is a multi-center controlled study evaluating laser treatments of infected great toes in a randomized blinded study of approximately 125 subjects. Right and left great toes are randomized to treatment or no treatment. Samples from infected areas are sampled and evaluated for presence of fungus with KOH, PCR and culture tests. Nail bed clearing and nail plate growth are measured from high resolution photographs by a blinded evaluator. Subjects will be evaluated at baseline and at 8, 16, 24 and 48 weeks for safety and effectiveness of study treatment.

Official Title
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Multi-Center Trial: Evaluation of PinPointe FootLaser Treatment for Infected Toenails (Onychomycosis)

Conditions
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Infected Toenails, Onychomycosis

Intervention / Treatment
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* Device: PinPointe FootLaser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteers of either sex, 18-80 years of age, Both great toes with clinical signs of infection. Positive KOH or culture test Exclusion Criteria: Existing or history of cancer/skin malignancy, Use of oral antifungal agents in past 6 months, Use of topical antifungal agents in past 1 month, Loss of protective sensation in either foot, Infection involving lunula of either great toe, Longitudinal streaks/spikes of either great toenail, Distal nail thickness > 2 mm of either great toe, Prior surgical treatment of either great toe in past 12 months, Participation in another medical device/pharmaceutical study, Condition that investigator determines makes it unsafe for subject to participate, Pregnancy, breastfeeding or plans to become pregnant.

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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Randomized great toe<br>Subjects with both great toes infected. Right/left randomized to treatment / no treatment | Device: PinPointe FootLaser<br>* Medical laser<br>|
| No Intervention: Untreated Toe<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nail Bed Clearing | Change in amount of clear nail over time. | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mycology | KOH, PCR and cultures of patients who were bilaterally positive or negative for each test. | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Toenail Fungus, PinPointe, FootLaser, Onychomycosis, Fungal nails