PinPointe FootLaser for the Treatment of Onychomycosis

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

To evaluate the safety and efficacy of the PathoLase FootLaser treatment of infected toenails.

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.

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.