Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis

Inclusion Criteria: * Subject is male or female, and 18 to 65 years of age, inclusive. * Subject has nail fungal infection of at least one great toenail (per visual assessment, positive KOH preparation, and positive dermatophyte culture). * Subject has target toenail showing 20-50% involvement without matrix (lunula) involvement. * Subject has 3 mm of unaffected nail (from proximal nail fold) on target toenail. * Subject has target toenail thickness of 3 mm or less. * Subject must be physically able to reach toes to clean, trim, and apply product to the target toenail. * Subject is willing and available to return for study follow up. * Subject or legal representative is able to understand and provide signed consent for participating in the study. * Female subject of childbearing potential has negative urine pregnancy test. * Females must be post-menopausal or must agree to use approved contraceptives (actions, de- vices or medications to prevent or reduce the likelihood of pregnancy) throughout the study (abstinence is NOT an accepted form of contraception). Exclusion Criteria: * Subject has known hypersensitivity or allergy to the product materials. * Subject has negative KOH preparation or dermatophyte culture. * Subject has dermatophytoma on target toenail. * Subject is enrolled in another investigational drug, device, or product protocol that would interfere with this study. * Subject is using other topical or pharmaceutical treatments for any nail conditions; a wash-out period of at least four weeks after discontinuation of a topical product or 12 months after discontinuation of an oral product or light-based therapy for treatment of nail fungus is required. * Subject has history of immunosuppression and/or clinical signs indicative of possible immunosuppression. * Subject with possible chronic disease, including: diabetes, psoriasis, immune deficiency (HIV), severe foot injury, chronic vascular disease, or in which delayed treatment (approved treatment) of DLSO for one year could present a significant health concern. * Subject has presence of toenail infection other than dermatophytes on target toenail. * Subject has any disease/condition that might cause toenail abnormalities or interfere with evaluation. * Subject has had previous toenail surgery on target toenail. * Subject is a pregnant or nursing female. * Subject is an Investigator, Nail Genesis' personnel, or Nail Genesis' Scientific Advisory Board (SAB) members, or their immediate family.