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 visualassessment, 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 thetarget toenail.
• Subject is willing and available to return for study follow up.
• Subject or legal representative is able to understand and provide signed consent forparticipating 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) throughoutthe 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 thatwould interfere with this study.
• Subject is using other topical or pharmaceutical treatments for any nail conditions; awash-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 fortreatment of nail fungus is required.
• Subject has history of immunosuppression and/or clinical signs indicative of possibleimmunosuppression.
• Subject with possible chronic disease, including: diabetes, psoriasis, immunedeficiency (HIV), severe foot injury, chronic vascular disease, or in which delayedtreatment (approved treatment) of DLSO for one year could present a significant healthconcern.
• Subject has presence of toenail infection other than dermatophytes on target toenail.
• Subject has any disease/condition that might cause toenail abnormalities or interferewith 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' ScientificAdvisory Board (SAB) members, or their immediate family.