Q&A: Does laser toenail treatment work?

I’ve seen ads for the PinPointe FootLaser, which promises to treat toenail fungus. Does it work? —A.G., Port Chester, N.Y.

That’s unclear. The laser’s manufacturer only provided us with one small, poor-quality study involving 17 patients with toenail fungus, most of whom appeared to experience remarkable improvement after the treatment. While the study reported no adverse effects, the system zaps the fungus with very high heat, which in theory could damage healthy tissue around the toenail. And it costs about $1,000, which insurance doesn’t cover.

Until more evidence is available, it’s probably best to stick with more-established treatments, including the oral drugs itraconazole (Sporanox and generic) and terbinafine (Lamisil and generic), and the topical drug ciclopirox (Penlac and generic), which is slightly less effective but has fewer side effects than the oral drugs.

Find out what could be causing your toenail fungus and see our tips on keeping your nails healthy. And for more on how to get rid of toenail fungus, see our comparison of 7 drug and non-drug treatments (subscribers only), including the ones mentioned above.

Comments

[Dr. Eric Bornstein]

Nomir Medical Technologies:

There is another company that has completed pivotal FDA trials with a novel laser system for the treatment of Onychomycosis, and is currently awaiting FDA approval for the therapy. This company is Nomir Medical Technologies, and I am its Chief Science Officer.

The FDA pivotal study was:

1)performed at 4-different sites;
2)Bllinded,
3)Randomized
4)IRB approved

The preliminary data from this trial was presented at the Council for Nail Disorders at the Dermatology meeting in San Franciso earlier this year.

These are the peer-review publications that have recently been published with the Noveon technology, describing its photo-biologic indications for nbacterial and fungal photo-inactivation.

1. Bornstein, E.S., Y.P. Krespi, A. Robbins, J. Wlassich, E. Sinofsky (2008) Antimicrobial resistance reversal at physiologic temperatures in MRSA in the nares with an 870 nm and 930 nm dual wavelength noveon laser. 2008 Tissue Engineering and Regenerative Medicaine International Society North America Meeting Abstracts.

2. Bornstein, E.S., A.H. Robbins, M. Michelon (2008) Photo-inactivation of fungal pathogens that cause onychomycosis in vitro and in vivo with the noveon dual wavelength laser system. 2008 New Cardiovascular Horizons Meeting Abstracts.

3. Bornstein ES, Michelon M: Examining the antibacterial action spectrum in vitro of the Noveon® dual wavelength laser system through photo-inactivation of E. coli at physiologic temperatures. Abstract presented at ASLMS, National Harbor, Maryland, 2009.

4. Bornstein ES: Treatment of Onychomycosis Using the Noveon® Dual-Wavelength Laser. FDA Pivotal Study data presented at Council for Nail Disorders 13th Annual Meeting, San Francisco, CA, 2009.

5. Bornstein ES: A Review of Current Research in Light-Based Technologies for Treatment of Podiatric Infectious Disease States, Journal of the American Podiatric Medical Association Volume 99 Number 4 348-352 2009

6. Bornstein E., Hermans W., Gridley S., and Manni J. Near infrared Photo-inactivation of bacteria and fungi at physiologic temperatures. Photochemistry and Photobiology Published on-line Aug 2009).

All of the research and data collection for these sudies was done in a blinded fashion with an independent CRO, and with certified Animal Review Boards approving the animal studies and Human Investigational Review Boards approving the Human studies. The statistical analysis for each study was accomplished by an additional (and different) independent CRO from the laboratory that we conducted the experiments in.

These important criteria are what makes research valid and acceptable to the FDA and peer-review journals. Only upon FDA approval for the indication of onychomycosis, will the device be sold for the therapy.

There are currently NO medical devices FDA approved for the treatment of onychomycosis.

We believe that the FDA will approve the Noveon Laser for the treatment of Onychomycosis within the next couple of months under the 510(K)process.

If you desire further information, please take a look at our web site: www.nomirmedical.com

Thanks you,

Eric Bornstein
Chief Science officer
Nomir Medical Technologies

[S. Chris Horine, DPM - Neat Feet Podiatry Laser Center]

It is true that the original study in 2007-2008 involved on the 17 patients but as you said the results were remarkable. I was the first doctor to receive the PinPointe FootLaser after this initial study was completed. After treating hundreds of patients for the past year, we have seen over 90% of the nails grow out normally with one 30 minute treatment. I would like to correct an error in your comments. The fungus is not destroyed with heat. The fungus is destroyed by the specific wave length delivered by the laser in a pulsed phase to prevent thermal build up.

[G. T. Nowell]

Why spend a lot of money when plain white vinegar works just as well. It's not as fast but works. I know from personal experience.