Evaluating the Safety, Tolerability and Preliminary Efficacy of Plasma in Improving the Appearance of Onychomycosis

Exclusion Criteria

• •1. Subject with more than 6 infected toenails
• •2. Subject with fingernail onychomycosis
• •3. Subject with one or more of the following conditions on the primary target toenail:
• •1. white superficial onychomycosis
• •2. dermatophytoma or "yellow spike/streak"
• •3. primarily lateral or bi-lateral disease
• •4. toenail thickness greater than 3 mm
• •5. inability to become normal in the opinion of the investigator
• •4. Subject with psoriasis, pincer nail, prior nail surgery, severe moccasin-type tinea pedis requiring treatment, symptomatic interdigital tinea pedis, lichen planus, or other abnormalities that could result in a clinically abnormal nail;
• •5. Subject with peripheral vascular disease or peripheral circulatory impairment;
• •6. Subject with uncontrolled diabetes mellitus, subjects with diabetes controlled by insulin or with known diabetic peripheral neuropathy
• •7. Subject with any known immunodeficiency;
• •8. Any pacemakers, or any metallic implants or prostheses in the vicinity of the treatment site (such as ankle, foot, etc.);
• •9. Subject with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with study evaluations or optimal participation in the study;
• •10. Subject who has received systemic antifungal therapy within 6 months (except single diflucan tablet for vaginal candida) or topical antifungal therapy applied to the foot or toenails within 1 month of study entry;
• •11. Subject who has received radiation therapy, chemotherapy, and/or immunosuppressive drugs within 6 months of study, and/or oral corticosteroids for \>1 month within the 6 months of study (exception: inhaled steroids);
• •12. Subject known to have received treatment with investigational drugs or devices within 30 days prior to enrollment into this study;
• •13. Subject who is unwilling to abstain from any cosmetic nail or foot treatments outside those provided by the study clinic, beyond basic nail trimming (i.e. no spa foot treatments, no pedicures/toenail polish use, no other topical prescription toenail medication);
• •14. Woman who is breastfeeding, pregnant, or intends to become pregnant (check via urine test only);
• •15. Subject who is part of the staff personnel directly involved with this study or a family member of the investigational study staff;