Dr's Huppin and Hale (www.footankle.com) have provided this great summary regarding the new toenail fungus laser treatment. I have updated the article where appropriate:
Current Recommendations: At this time we recommend that patients avoid laser treatment for fungal nails. There is not enough evidence that it works well enough to justify the cost. Below we provide information on laser treatments. We'll start with a review of current research on oral medications so that we can compare laser treatment to the oral medications which are regarded as the most current effective treatment option.
What Do Studies Show About the Effectiveness of Oral Medication for Fungal Nails?
- Mycological cure (100% resolution of fungus from nail sample):defined as patient's nail sample does not show fungus under a microscope and does not grow fungus in a laboratory medium. Mycological cure does not evaluate visual appearance of nail.
- Effective treatment - defined as mycological cure and >5mm of unaffected nail growth (thus clinically still signs of fungus)
- Mycological cure plus clinical cure (no laboratory or visual signs of nail fungus)
The oral pill Lamisil demonstrated the following in studies:
- 70% Mycological cure (no laboratory signs of fungus).
- 59% Effective Treatment 48 weeks after a 3 month treatment of oral antifungal (no laboratory signs of fungus and >5mm of unaffected nail growth).
- 38% Mycological cure plus Clinical cure (no laboratory or visual signs of nail fungus).
There are four companies developing lasers for treatment of toenail fungus. PinPointe FootLaser, Noveon laser, CoolBreeze Laser and GenesisPlus Laser.
How does Pinpointe laser study assess results of fungal toenail treatment?
- Nail Bed Clearing - visual improvement of nails measured by analyzing high resolution photographs. They do NOT mention Mycological cure (no laboratory signs of nail fungus). They only mention visual improvement and not laboratory signs of improvement. They also do not state what percent or size of nail improvement defines "nail bed clearing".
On October 15th, 2010 the PinPointe™ FootLaser™ received FDA clearance as an indication "for use for the temporary increase of clear nail in patients with onychomycosis". According to the government web site nail bed clearing is "measured from high resolution photographs". Also, they excluded patients with end of nail thickness greater than 2 mm of either great toe. PinPointe Laser did not publish their FDA clinical study results on the government web site but their web site states "“PinPointe submitted clinical evidence to FDA demonstrating that after a single treatment, between 68 percent and 81 percent of patients experienced increased clear nail at six and 12 months and 81 percent of all patients had sustained improvement at 12 months". Again they do not state what percentage of nail improvement defines "clear nail" and we are not sure why the FDA letter states "temporary increase of clear nail".
II. Nomir Medical Technologies Noveon laser: Nomir, according to the government clinical study web site is "currently recruiting participants" for their government study. Nomir has some positive early results in well run studies. Nomir, however, is waiting for FDA approval before bringing their Noveon laser to market. This is an ethical approach and we applaud them for it. So far we find Nomir to be the company with the best evidence for use of their laser; however, their laser is not yet on the market. As of early 2011, there are some rumors that Noveon has run into financial trouble. We will keep an eye on this and send an update when more information is available. A study on the use of the Noveon laser in the treatment of onychomycosis was published in JAPMA, June 2010. Results showed the following results 180 days after laser tx: 65% with at least 3 mm of clear growth, 48% with negative laboratory/microscopic findings (PAS), 39% with negative culture and at least 3 mm of cleared nail growth.
III. Two other companies, CoolTouch (CoolBreeze Laser) and Cutera (GenesisPlus Laser), have started marketing their lasers for treatment of toenail fungus. Both of these companies seem to have had lasers available for treatment of other problems and have decided to jump on the bandwagon and start marketing them for treatment of fungal nails. Neither of these companies appear to have any evidence based studies that support the use of these lasers in treatment of fungal nails. CoolTouch has not obtained FDA approval for treatment of fungal nails as of this update. It was recently announced that Cutera has received FDA approval (as of 04/11/11).
How do these lasers differ from each other?
Each of these lasers work on a different wavelength of light and different wavelengths have different effect on fungus and on human tissue. This means that any studies that are done must be done with the specific light wavelength to determine if a particular laser is effective at killing fungus and safe to use on humans. That is why the format of the studies is so important. A result from a study on one laser has absolutely no relationship to other lasers.
Our Current Recommendations on Lasers for Treatment of Fungal Nails
The FDA does not feel there is any valid evidence that these lasers work to cure nail fungus. If you are looking to have a normal looking nail, laser treatment is probably a waste of your money. If your great toe nail thickness at the tip is less than 2mm and you would like to have a chance at temporary increase of clear nail you could try the PinPointe Laser but you must weigh the cash price verses the FDA statement temporary increase of clear nail. Also, clear nail seems to mean just some visual improvement not a perfect looking nail. The thicker your nail the higher chance of failure.
Our opinion is that you should avoid the Nomir Medical Technologies Noveon laser, CoolBreeze laser by CoolTouch and the Genesis plus laser by Cutera since they do not have FDA clearance. We welcome input from these companies if they can provide evidence based studies showing the effectiveness of their lasers. We are more hopeful that the Noveon laser will be able to provide effective treatment, but we have not seen any new information from Noveon in several months.
Dr's Hale and Huppin DPM (www.footankle.com)
On a personal anecdotal level, I have had the experience of performing and observing different laser nail treatments on hundreds of patients while working as a resident in the office of different podiatrists in Utah. Other than mild pain with very few patients the laser had no noted side effects. Outcomes mirrored the above literature review. Only patients with mild cases of proven fungal infections had reliable outcomes. Very thick nails often appear to be resistant to this treatment likely because of the thickness of the nail and the inability of the laser to penetrate to the needed depth. Also, thickened nails can often be the result of microtrauma combined with fungal infection meaning that even if the fungus is eliminated, the nail may still appear thickened. I would only recommend the laser option for very mild fungal infections at this time and only if you can spare this amount of cash.
The most effective, scientifically proven treatment option at this time is a three month course of Lamisil combined with long term use of topical antifungal medication (ie Formula 3).
Dan Preece, DPMOffice: 801-532-1822, Fax: 801-532-7544Address: 430 N. 400 W. Salt Lake City, UT 84103E-Mail: [email protected]Website: saltlakecitypodiatrist.netFoot & Ankle Specialists