Status:
COMPLETED
Diode Laser Treatment of Onychomycosis
Lead Sponsor:
ConBio, a Cynosure Company
Conditions:
Onychomycosis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01452490
Start Date
October 1 2011
End Date
August 1 2013
Last Update
October 28 2020
Active Locations (2)
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1
Shoreline Foot and Ankle Center
New London, Connecticut, United States, 06320
2
Shoreline Foot and Ankle Center
Westbrook, Connecticut, United States, 06498