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: Laser’s should only be used for slight cases of fungal nail infections unless adverse effects from Lamisil (ie pt has a compromised liver or wants to avoid any possibility of liver complication) in which case lasers are a safe option albeit less effective.
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. Cutera (GenesisPlus Laser).
• Summary of results 16 weeks post final
treatment of the 37 nails treated:
• 30 nails (81%) showed either “complete clearance” or
“moderate to significant” clearance
• 19 nails (51%) showed “complete clearance” with 100%
testing negative for fungi
• 6 nails (16%) that showed no improvement had a turbidity
of 10 at baseline
IV. CoolTouch (CoolBreeze Laser) has started marketing their lasers for treatment of toenail fungus. This company seems 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. No good studies available, FDA approval pending.
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 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 or Genesis 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 until they obtain 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.
Dr’s Hale and Huppin DPM (www.footankle.com)
Summary (Dr. Preece):
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 very mild pain, few patients have reported any side effect from the laser treatments. Outcomes mirrored the above literature review with results less reliable than Lamisil pills but with fewer side effects by far. Only patients with mild cases of proven fungal infections had reliable outcomes but some difficult cases are seen with great success. 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 because of scaring of the matrix. I would only recommend the laser option for very mild fungal infections at this time if you are looking for reliable results. However, if you health precludes any medication that is processed through the liver and you have the money, then laser treatment can be a viable option.
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 or Penlac).
Dan Preece, DPM
Dan Preece, DPM & Darren Groberg, DPMOffice: 801-532-1822, Fax: 801-532-7544Address: 144 South 700 East SLC, UT 84102-1109Foot & Ankle Specialists