Diode Laser Treatment of Onychomycosis

Therapuetic Areas:Orthopedics / Podiatry
Age Range:Any
Start Date:October 2011
Contact:Hilary Maynard

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Study of the V-Raser Diode Laser System in the 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

- Fitzpatrick Skin Type I-IV

- Written and verbal informed consent

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

- 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

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

- Distal nail thickness of greater than 2mm in the affected great toenail
We found this trial at
New London, Connecticut 06320
New London, CT
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