Laser Treatment for Toenail FungusSome patients have asked about laser treatments for toenail fungus and whether they work. Here's what we've found out.Currently, no laser system is approved by the FDA for nail anti-fungal treatments. This is primarily because there are no studies proving the safety and effectiveness of the treatments. Investigative news articles are the only unbiased reviews we have found: New York Times - False Start on a Laser Remedy for Fungus There are two laser systems looking for customers: Pinpointe and Noveon. However, neither has received FDA approval. The most common system is the Pinpointe laser, which is only approved for use in dentistry and soft-tissue cutting, not anti-fungal treatments. The study they performed had just 16 patients, which is never an adequate number to claim any benefit. The company announced a larger clinical trial of 125 patients in mid-2009 but there have been no updates since. No studies have been done that separate the effects of the laser and the prescription anti-fungal cream that need to be applied twice per day. It is unknown if the laser works alone or how much of an effect the cream has. The competing Nomir Medical Noveon laser has a little better study with a clinical trial of about 40 patients with clear nail growth in 76% of patients after 6 months. Still, they're waiting for approval by the FDA. Devices that are not approved by the FDA cannot be marketed for unapproved uses, but that has not stopped doctors from doing it. And contrary to what some believe, the marketing restriction covers both the manufacturer and the doctors. Nevertheless, the FDA will probably not sanction individual doctors. Our Take With a price tag of around $1000 and not covered by insurance, it is a lot of money to risk on unproven treatments. We are following the developments in the industry and will update our patients when we have additional news. We are waiting for FDA approval so we can evaluate whether you should give the systems a try. If you would like to receive updates about the laser treatments, send an email to laser@ForFeetSake.com and we will let you know when we get news. |
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