evaluation of the effectiveness of nail genesis dlso product for onychomycosis

Conditions: Distal Lateral Subungual Onychomycosis; Onychomycosis

Summary: this is a pre-ide, prospective, multicenter, randomized, parallel-group, double-blind, vehicle- controlled study to evaluate safety and effectiveness of nail genesis dlso product for the treatment of dlso compared with vehicle in infected great toenails in a total of 338 males and non-pregnant, non-lactating, females between 18 and 65 years of age (inclusive). subjects will be randomized in a 2:1 ratio to receive either nail genesis dlso product or vehicle. subject eligibility will be determined during a screening assessment. subjects will complete a 4week washout period after discontinuation of a topical product or a 12-month washout period after discontinuation of an oral product or light-based therapy prior to randomization. eligible subjects will be randomized in a 2:1 ratio to receive nail genesis dlso product or vehicle, respectively. during the 52-week trial, study medication will be administered once daily to the target toenail for 48 weeks. a subject will be considered to have completed the study when he or she has completed the study assessments at week 52. the 52-week visit is for follow-up safety assessments.


Eligibility criteria:
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.