One of our readers recently sent the blog the following comment:
“Anything new to add to comments in book about laser treatment of fungal nails? In my area there are ads for DPMs offering this $1000 per treatment! My question is; does it work?”
Up to this point I have been tacitly avoiding this topic waiting for all of the chips to fall into place. I guess it is time to, at least give my initial thoughts. I will start by disclosing that I was a member of the original Patholase/PinPointe Advisory Board although I am currently not working with that company and I am a current Advisory Board member for Nomir. Being under a non-disclosure agreement with both I must therefore be very careful to only give background information that is in the public domain and give only MY OPINION based on the information in the public domain so as not to let slip any confidential information that I may have picked up along the way. This is another reason I have not written about this topic.
Although there may be more than two commercial products to mention, I will limit my discussion to the two best known, the PinPointe Laser from Patholase and the Noveon Laser from Nomir. These are totally different devices that use different forms of laser energy. As I write this NEITHER is FDA approved specifically for the treatment of onychomycosis although both have a device clearance for general podiatric and dermatologic use. Interestingly, if you actually look for the specifics of that general definition, onychomycosis is not included.
To this point each company has taken very different marketing approaches. PinPointe, despite not having the FDA approval, has been aggressively marketing the device to podiatrists based on their general usage clearance. Up to this point, their publically available data supporting the use of the device for onychomycosis has been limited to a small number of patients originally treated pre-marketing and by early adapters of the device. This data is not from a prospective, IRB approved, randomized controlled trial. To their credit, a quick search on www.clinicaltrials.gov under the term “onychomycosis” does reveal that they are currently engaged in such a clinical trial. They also continue to collect retrospective data from current users. To the best of my knowledge they have published no studies based on their clinical data or their technology.
Nomir has taken the path of performing an initial three IRB approved, prospective clinical trials and has submitted their pivotal trial to the FDA in an attempt to receive an onychomycosis indication. Their technology, using a dual wavelength (870 & 930 nm) near infrared (IR) laser light to cause photoinactivation of both fungus and bacteria, including T. rubrum and MRSA, at physiologic temperatures, has been shown to be successful in vitro and in vivo, and was recently published by its developer Dr. Eric Bornstein http://www.nomirmedical.com/products/publications.htm in the Nov/Dec 2009 issue of Photochemistry and Photobiology. They have also submitted the preliminary results of their pivotal clinical data for the treatment of onychomycosis which has been accepted for publication in a peer reviewed, indexed journal. Although they have signed up podiatrists to be trained on the device, it has not yet been made commercially available.
Enough background…to answer the question that initiated this discourse, I guess I would have to say that, yes, given the data I have seen, these two laser therapies do, in fact, show positive results in the treatment of onychomycosis. Will they work in every patient with nail fungus? Of course not! Even oral terbinafine only had a 38% total cure rate in its clinical trials. Which brings up another question…do they work even as well as the oral agents? Frankly, no one can say at this point without seeing the results of the same type of well designed, controlled trials that those drugs went through. I will say this much for certain, there is no risk of systemic toxicity with the lasers as there is with the oral drugs, no matter how rare. Is the treatment worth $1000? That is something that only an individual patient can answer. I hear through the proverbial grapevine that there has been no shortage of folks willing to pay that or similar amounts for the treatment. Heck, there are scores of physicians specializing in cosmetic treatments, some without rigidly controlled and studied FDA approved data, that have done quite well promoting their services.
Until more information is available on which definitive statements can be made, I would have to advise each of my readers to use their own moral and ethical compass in determining what is appropriate for their patients and their practice. I would really appreciate any comments you may have if you are currently using a laser on either your own patient experience or if you have seen patients treated by other docs and their satisfaction level.