Diode Laser Treatment of Onychomycosis (NCT01452490) | Clinical Trial Compass
CompletedNot Applicable
Diode Laser Treatment of Onychomycosis
United States50 participantsStarted 2011-10
Plain-language summary
The purpose of this study is to evaluate the V-Raser diode laser system with investigational Nail Fungus Handpiece in the treatment of onychomycosis.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 invo…
What they're measuring
1
Amount of Clear Nail Growth from Baseline in mm or as measurement of total area of involvement