Study of the Use of Low Level Laser Light Therapy to Treat Toenail Fungus

Inclusion Criteria

• Onychomycosis present in at least one great toenail.
• Disease involvement is at least 25%.
• Subject is willing and able to refrain from employing other (non-study) treatments (traditional or alternative) for his or her toenail onychomycosis throughout study participation.
• Subject is willing and able to refrain from the use of nail cosmetics such as clear and/or colored nail lacquers throughout study participation.

Exclusion Criteria

• Spikes of disease extending to nail matrix.
• Infection involving lunula, e.g., genetic nail disorders, primentary disorders.
• Less than 2mm clear (unaffected) nail plate length beyond the proximal fold.
• Presence of dermatophytoma (thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed).
• Chronic plantar (moccasin) tinea pedis.
• History of current or past psoriasis of the skin and/or nails.
• Concurrent lichen planus.
• Onychogryphosis.
• Any of the following conditions of the great toenail:
• proximal subungual onychomycosis
• white superficial onychomycosis
• dermatophytoma or "yellow spike/streak"
• exclusively lateral disease
• confounding problems/abnormalities of the great toenail(s).
• Any abnormality that could prevent a normal appearing nail if clearing of infection is achieved.
• Inability for the toenail to become normal in the opinion of the investigator.
• History of multiple repeated failures with previous therapies for onychomycosis.
• Trauma to the affected great toenail(s).
• Use of oral antifungal agents in the past 6 months.
• Use of topical antifungal agents in the past 1 month.
• Prior surgical treatment of the affected great toe(s).
• Cancer and/or treatment of any type of cancer within the last six months.
• Peripheral vascular disease or peripheral circulatory impairment.
• History of uncontrolled diabetes mellitus.
• Known immunodeficiency.
• Known sensitivity, or contraindication, to light therapy.
• Pregnant, breast feeding, or planning pregnancy prior to the end of study participation.
• Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
• Developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to follow study subject requirements and/or record the necessary study measurements.
• Involvement in litigation and/or receiving disability benefits related in any way to the parameters of the study.
• Participation in a clinical study or other type of research in the past 30 days.