“The problem is huge. It is bigger than you can imagine,” says Washington podiatrist Stephen J. Kominsky. “I would say 70 percent of the patients who come into my office have fungal infections on their toenails.”
There may be hope. Podiatrists have begun using a laser treatment that combats the infection — or wastes their patients’ money because it doesn’t work, depending on whom you ask.
The treatment, in which the podiatrist aims a laser beam at the patient’s toenails to kill the organisms that cause the fungus, costs about $1,000 and is not covered by insurance because it is considered an aesthetic procedure. The nails aren’t immediately clear after the treatment, which takes up to an hour; the patient must wait for the fungus-free nails to grow out.
Last year, the Food and Drug Administration cleared the first laser, PinPointe, for “temporary increase of clear nail” in patients with onychomycosis, the medical term for a fungal infection of the nail. The FDA cleared a second one, GenesisPlus, in April. Practitioners have been using other lasers on toenail fungus since about 2009.
‘No side effects’
Kominsky has treated 400 to 500 patients with the PinPointe laser. Compared with oral medication, he says, “the odds of success are better with the laser; plus, there’s no side effects.”
The most common oral treatment, Lamisil, works for about two out of three patients, according to Lamisil’s FDA-approved prescribing information, but it has been associated with rare cases of serious liver problems. Other potential side effects include diarrhea, headache, rashes and changes in taste. According to Lamisil’s manufacturer, Novartis, the relapse rate is 15 percent one year after completing treatment.
In one small study about laser treatment for toenail fungus, which appeared last year in the Journal of the American Podiatric Medical Association, “26 eligible toes (ten mild, seven moderate, and nine severe)” were treated with a laser produced by Nomir Medical Technologies, which is still seeking FDA approval. After six months, 85 percent of the toenails had improved.
“I never use the term ‘cured’ with toenail fungus,” Kominsky says. “With a cure, people think there’s no chance for a recurrence. In this case, there is a chance.”
Even John Strisower, the founder of PinPointe USA, says patients should expect at least a minimal reinfection within five years after laser treatment.
Routes of infection
Research done by PinPointe, which is based in Chico, Calif., identified more than 100 organisms, including fungi, yeast, mold and bacteria, that work together to cause toenail fungus.