Diode Laser Treatment of Onychomycosis

Inclusion Criteria:

- Confirmed subungual onychomycosis in a great toe that does not extend to the
eponychium

- Fitzpatrick Skin Type I-IV

- Written and verbal informed consent

- Able to comply with study instructions and to return to the clinic for required
visits

- Agrees to refrain from other active topical, laser or light-based treatment to the
great toes

- Agrees to the use of Naftin Gel between the toes to prevent/control tinea pedis

Exclusion Criteria:

- Pregnancy, breastfeeding or planning to become pregnant

- History of cutaneous photosensitivity, porphyria and hypersensitivity to porphyrins
or photodermatoses

- Any skin pathology or condition that could interfere with the evaluation or that
requires the use of interfering topical or systemic therapy

- Coagulation disorder or current use of anti-coagulation medication (including aspirin
use of greater than 81 mg per day)

- Any condition which, in the investigator's opinion, would make it unsafe for the
subject to participate

- Enrolled in an investigational drug or device trial, or has been treated with an
investigational device or received an investigational drug within 30 days

- Oral Lamisil within 1 year, Sporanox or over-the-counter topicals within 1 month, or
other prescription anti-fungal medications or topicals within 6 months

- Evidence of diabetic neuropathy or peripheral vascular disease related to diabetes,
or a loss of protective sensation in the affected foot

- Psoriasis, lichen planus, infection involving the lunula, prior surgical treatment of
the affected great toe within 1 year, or a history of trauma to the affected great
toe

- Immunocompromised status, or with existing (or history of) cancer/skin malignancy

- Distal nail thickness of greater than 2mm in the affected great toenail