Diode Laser Treatment of Onychomycosis

Cynosure

Status: Completed

Conditions: Onychomycosis

Treatments: Device: Diode Laser Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT01452490

D4-11-F

Details and patient eligibility

About

The purpose of this study is to evaluate the V-Raser diode laser system with investigational Nail Fungus Handpiece in the treatment of onychomycosis.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Diode Laser Treatment

Experimental group

Treatment:

Device: Diode Laser Treatment