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

An infection of toenail fungus, or onychomycosis, occurs when fungi infect one or more
nails. As the nail fungus spreads deeper into the nail, it may cause nail discoloration,
thickening and the development of crumbling edges, all of which can lead to an unsightly and
potentially painful problem. Onychomycosis is difficult to treat, and infections recur
easily. Toenail fungus affects approximately 23 million people in the US - about 10% of all
adults. Currently available treatments for toenail fungus are lacking. Even the most
effective oral medications are successful only about half of the time. Topical medications
are successful less than 10% of the time. Recently, research has found laser therapy to show
promise as a novel alternative treatment for toenail onychomycosis. Unlike medication-driven
treatments for toenail fungus which can have many side effects including serious ones such
as liver toxicity, laser therapy presents minimal risk of side effects. Laser therapy is
applied to toenail onychomycosis by shining a laser light through the toenail. The laser
light vaporizes the fungus while leaving the skin and surrounding tissue unharmed.

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.