laser treatment for toenail fungus

I have been asked by some of my patients recently about laser treatment for toenail fungus (onychomycosis in medical jargon). Various practices have been advertising this treatment using a new laser technology developed by Patholase Inc. in Chico, which has spun off a company called PinPointe Laser, Inc. to promote this treatment for toenail fungus. The laser treatment is not yet approved by the FDA as effective and safe for treating toenail fungus. It has received CE certification in the European Union which addresses safety rather than efficacy, as I understand it. The laser treatment has been featured on various television shows including Good Morning America. According to the company, it is 88% effective, more effective than any other treatment, although this did not mention how long a follow up period. The ads and information I saw from the company also did not specify whether this 88% referred to a mycologic cure (negative cultures for fungus) or an overall cure (normal nails after a 12 to 18 month follow up period). I have thus far been able find no evidence that this treatment works, nor how it compares to terbenafine (Lamisil), the standard treatment right now, from any systematic studies. Although the company's advertisements mention clinical trials, the results of these do not appear to be published in the medical literature as yet. It would be great to have an effective treatment out there which did not have the side effects of Lamisil and which therefore did not require constant liver function test monitoring. Your feedback welcome... please comment if you've experienced this treatment and want to share your experience, either positive or negative, with readers of this blog.

What is clear is that the treatment, because it is not yet approved by the FDA, is not covered by any insurance plan, and costs $1100-$1200 at local providers here on the Peninsula in California. Patients are advised to use a topical treatment twice a day for the entire year or year and a half that it takes for the toenail to regrow. I saw a comment on Yelp suggesting that the effectiveness is just due to the topical therapy; however, this is unlikely in my view due to the fact that in clinical trials topical therapy, even using laquers and vehicles aimed at allowing better penetration into the nail, seem to have much less than the rate of efficacy reported by the company for the laser treatment.

The company stresses that the treatment is only a one-time 30 minute event. While this is true, like terbenafine and other treatments, it takes a year to a year and half for the new normal toenails to grow out.