A Trial of the Safety and Efficacy of EcoNail™ in the Treatment of Fungus Infections of the Great Toenail

Inclusion Criteria: * Subjects who are men and women greater than or equal to 18 years of age and less than or equal to 65 years of age. * Female subjects who are post-menopausal (amenorrheic for at least 1 year), surgically sterile, have a partner with a vasectomy, or routinely using an acceptable means of contraception (acceptable methods may include hormonal contraceptives, intrauterine device, spermicide and barrier, abstinence and partner/spouse sterility). * Subjects who have mycologically confirmed distal subungual onychomycosis of at least one or both great toenails ("target toenails"), defined as a positive result by office-based KOH preparation (± Chlorazol B) and by laboratory culture demonstrating one of more of the following organisms: T. rubrum, T. mentagrophytes, T. tonsurans and/or E. floccosum * Subjects who have target toenail showing 20-65% (+/- 2%) involvement as judged by the clinical investigator. * Subjects who have target toenail showing great than or equal to 3 mm distal involvement as judged by the clinical investigator. * Subjects who have target toenail showing great than or equal to 2 mm proximal clear nail at the cuticle. * Subjects must agree not to apply other nail polish or related products to the affected nails for the duration of the study. * Subjects must refrain from filing, clipping, or otherwise disturbing the treated nail(s) for the duration of the study \[NOTE: Clinic personnel will debride the affected nails during monthly visits. Su…