Study of the Use of Low Level Laser Light Therapy to Treat Toenail Fungus
The purpose of this study is to determine whether low level laser light is effective in the treatment of toenail fungus.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Evaluation of the Effect of the Erchonia FSS™ on Treating Toenail Onychomycosis Clinical Study|
- Mean % increased clear nail at 6 months post final laser treatment administration. [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]Mean per cent (%) increased clear nail at 6 months post final laser treatment administration (approximately 27 weeks post final treatment administration)determined from photographs.
- mm of clear nail bed [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]Change in mm of clear nail bed from Baseline to 27-week post final treatment administration (study endpoint) as measured from digital photographs.
|Study Start Date:||April 2011|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Experimental: Erchonia FSS Laser
Application of active low level laser therapy light to the affected toenail.
Device: Erchonia FSS Laser
The Erchonia FSS™ is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635nm are activated simultaneously for 10 minutes of total treatment administration time.
An infection of toenail fungus, or onychomycosis, occurs when fungi infect one or more nails. As the nail fungus spreads deeper into the nail, it may cause nail discoloration, thickening and the development of crumbling edges, all of which can lead to an unsightly and potentially painful problem. Onychomycosis is difficult to treat, and infections recur easily. Toenail fungus affects approximately 23 million people in the US - about 10% of all adults. Currently available treatments for toenail fungus are lacking. Even the most effective oral medications are successful only about half of the time. Topical medications are successful less than 10% of the time. Recently, research has found laser therapy to show promise as a novel alternative treatment for toenail onychomycosis. Unlike medication-driven treatments for toenail fungus which can have many side effects including serious ones such as liver toxicity, laser therapy presents minimal risk of side effects. Laser therapy is applied to toenail onychomycosis by shining a laser light through the toenail. The laser light vaporizes the fungus while leaving the skin and surrounding tissue unharmed.