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Treatments for toenail fungus:
Laser Treatment of Toenail Fungus

Experts estimate that 35 million people in the United States and 700 million worldwide suffer from toenail fungus, or onychomycosis. Until recently, the choices of treatment for fungal nail infections were very limited. Topical antifungal treatments are ineffective in curing toenail fungus in a large percentage of cases. Ciclopirox, an antifungal lacquer that is painted on the infected toenails for 48 weeks, achieves a total cure in less than 10% of patients treated. Oral medications are more effective, particularly the newer drugs such as terbinafine (Lamisil) and itraconazole (Sporanox), but raise safety concerns. In addition, pharmaceutical antifungal therapy is not appropriate for many people suffering from toenail fungus, including people with liver disease, kidney impairment, pregnant women and nursing mothers. As a result, many people continued to suffer with their unsightly thick, yellow nails.

Given all the problems of conventional treatments, medical device companies are seeking to develop innovative ways to treat onychomycosis. Recently, through technology, suffers of toenail fungus have been presented with a new solution to the age-old problem - laser treatment. Though very new, and still undergoing FDA trials, laser treatments offer a promising cure for the dreaded toenail fungus.

Currently, there are no laser devices approved by the U.S. Food and Drug Administration (FDA) for treatment of nail fungus. One laser has been approved for dermatology and plastic surgery while the other is in what its maker hopes is the final stages of FDA approval. The two competing systems are:

The Pinpointe FootLaser is FDA-cleared as a laser for use in dermatology and plastic surgery. Since the laser has not been approved by the FDA specifically for the treatment of nail fungus, using the laser to treat nail fungus is an off-label use. Doctors are free to use the laser to treat toenail fungus, but the manufacturer, Pinpointe USA, Inc., cannot promote or market the device for that purpose in the United States. The manufacturer has submitted data to the FDA in the hope of getting approval to market the device to treat onychomycosis.

Nomir Medical Technologies has secured clearance from FDA to utilize the company's Noveon laser device during contact and non-contact surgical procedures of the skin, subcutaneous tissues and nasal passages in dermatology, plastic surgery, podiatry, and otolaryngology.

How Does Laser Treatment Work on Toenail Fungus?

Although the two devices differ in their application and design, both work by shining specific wavelengths of near infrared light through the nail plate. The light is intended to destroy the fungus, mold or yeast that are under the nail plate and which are causing the infection.

The laser light has no effect on the surrounding healthy tissue. There is no pain but some patients experience temporary warmth in the nail during treatment.

Below is a discussion from the televsion program The Doctors illustrating how laser treatment kills the toenail fungus

The Pinpointe treatment is a single treatment that typically takes about half an hour. Noveon therapy is expected to require multiple visits (typically 4 treatments at days 1, 14, 42 and 120) to eradicate the fungi, molds and yeasts that may be causing the onychomycosis.

Are Laser Treatments Effective to Cure Toenail Fungus?

PinPointe reports that in a clinical trial conducted in California, 88% of the treated patients grew out a normal looking nail after one treatment. Nomir states that Noveon therapy treatments resulted in 87% clinical improvement in a human pilot study. Those numbers are significantly higher than the results of studies on terbinafine, the most effective pharmaceutical drug for onychomycosis.

The results reported by the laser device manufacturers seem promising, but prospective patients should understand that these results are based on very small study sizes and the studies may not meet the rigorous standards of studies undertaken on the pharmaceutical treatments. In addition, since the use of the laser in treating toenail fungus is a very new technology, there is little or no information on the long term effectiveness of the treatment or the recurrence of the toenail fungus after completion of the laser treatment.

In short, while the initial reports seem to point to laser therapy as the most effective available treatment of onychomycosis, much more data needs to be developed before a comprehensive evaluation of the technology can be made.

Side Effects of Laser Treatment of Toenail Fungus

In clinical studies there have been no adverse reactions, injuries, disabilities or known side effects. In addition, there are no restrictions based on age or other conditions which might restrict treatment. This contrasts with oral medications now used to treat toenails, which carry some risk of side effects that can affect the liver, kidneys, and skin and are not recommended for patients with liver or kidney problems or for pregnant women or nursing mothers.

Cost and Insurance of Laser Treatment of Toenail Fungus

The cost of the laser treatment fee will vary, but the cost of Pinpointe laser therapy is generally in the range of $1,000. Typically, the treatment includes consultation with the doctor, any necessary nail preparation or filing and post treatment follow up.

Because laser treatment of toenail fungus is considered aesthetic, health insurance plans generally do not cover the treatment. Patients with a Flexible Spending Account (FSA) can use funds in their FSA account to pay for treatment.

The high cost of laser therapy (compared to oral medication such as terbinafine or nail lacquers such as ciclopirox), combined with the lack of insurance coverage may make laser therapy a less appealing choice for many patients suffering from fungal nail infections. For those who, for medical reasons, cannot be treated with available drugs, laser therapy may be offer a way to treat the fungus when other options present problems.