Early Feasibility Study to Evaluate the Efficacy and Safety of the RenewalNail™ Plasma Treatment System in Patients With Mild to Moderate Onychomycosis (Fungal Nail)

Inclusion Criteria

• Subjects who are between 21 to 75 years (inclusive) of age;
• Subjects male or female and of any race;
• Subjects who are in good general health and free from any clinically significant disease that might interfere with the study evaluations.
• Subjects with established clinical diagnosis of distal subungual onychomycosis;
• Subjects with at least one or both big toe nails involved with 20-75% infection;
• Subjects with both positive KOH and culture for onychomycosis dermatophytes in screening of nail samples;
• Subjects whose infection is confirmed to be caused by T. rubrum or T. mentagrophytes;
• Subjects who are willing and able to refrain from employing other (non-study) treatments (traditional or alternative) for his or her toenail onychomycosis throughout study participation;
• Subjects who are willing and able to refrain from the use of nail cosmetics such as clear and/or colored nail lacquers throughout study participation;
• Subjects who are willing and able to give written informed consent and able to adhere to procedures and visit schedules;
• Women of childbearing potential who are currently sexually active must agree to use a medically accepted method of contraception while receiving protocol specified treatment. Methods include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device, oral or systemic hormonal contraceptive (plus an additional reliable barrier method), surgical sterilization (e.g., hysterectomy or tubal ligation);
• Women of childbearing potential who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study;
• Women of childbearing potential must have a negative pregnancy test prior to start of study.

Exclusion Criteria

• Subjects with presence of dermatophytoma (defined as demarcated and localized thick masses) of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail;
• Subjects with onychomycosis infection involving lunula of the affected toenail(s) or spikes of disease extending to nail matrix in the affected big toenail(s);
• Subjects with conditions other than distal subungual onychomycosis known to cause abnormal nail appearance such as psoriasis, severe moccasin-type tinea pedis requiring treatment, symptomatic interdigital tinea pedis, lichen planus, or other abnormalities that could result in a clinically abnormal nail;
• Subjects whose foot is too large (larger than US men's size 13) or too small (smaller than US women's size 3) to properly fit into the plasma treatment device;
• Subjects with a history of multiple repeated failures with previous therapies for onychomycosis;
• Subjects whose affected big toenails cannot become normal in the opinion of the investigator;
• Subjects with abnormality of the affected big toenail(s) that could prevent a normal appearing nail if clearing of infection is achieved;
• Subjects with trauma to the affected big toenail(s) as identified by the study doctor;
• Subjects who received topical antifungal treatment of the nails within 2 weeks before study initiation;
• Subjects who received systemic antifungal treatment within 3 months before study initiation;
• Subjects with dementia or psychic condition that might interfere with the ability to understand the study and thus give written informed consent;
• Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment;
• Subjects who are unwilling or unable to refrain from employing other (non-study) treatments (traditional and alternative) for their toenail onychomycosis throughout study participation;
• Subjects who are unwilling or unable to refrain from the use of nail cosmetics such as clear and/or colored nail lacquers until the end of study participation;
• Subjects w