Diode Laser Treatment of Onychomycosis
Diode Laser Treatment of Onychomycosis
The purpose of this study is to evaluate the V-Raser diode laser system with investigational
 Nail Fungus Handpiece in the 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