Onychomycosis
Conditions
Keywords
Onychomycosis, Toenail Fungus
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.
Interventions
DEVICEDiode Laser Treatment
Laser treatment once every 6 weeks, for a total of 4 treatment sessions
Sponsors
ConBio, a Cynosure Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Even though this study has recruited more than 10 participants, it is a feasibility study, designed to test the prototype rather than measuring health outcomes. It is to confirm the operating specifications before beginning a full clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Clear Nail Growth from Baseline in mm or as measurement of total area of involvement | 12 months | Amount of lesion-free toenail growth (mm or total area of involvement) from Baseline, as judged by computer software analysis of photos. |
Countries
United States
Outcome results
None listed