Onychomycosis Clinical Trial
Official title:
Study of the V-Raser Diode Laser System in the Treatment of Onychomycosis
NCT number | NCT01452490 |
Other study ID # | D4-11-F |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2011 |
Est. completion date | August 2013 |
Verified date | October 2020 |
Source | Cynosure, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the V-Raser diode laser system with investigational Nail Fungus Handpiece in the treatment of onychomycosis.
Status | Completed |
Enrollment | 50 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Shoreline Foot and Ankle Center | New London | Connecticut |
United States | Shoreline Foot and Ankle Center | Westbrook | Connecticut |
Lead Sponsor | Collaborator |
---|---|
ConBio, a Cynosure Company |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Amount of Clear Nail Growth from Baseline in mm or as measurement of total area of involvement | Amount of lesion-free toenail growth (mm or total area of involvement) from Baseline, as judged by computer software analysis of photos. | 12 months |
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