A Laser Treatment Guide for Nail Fungus

medical-laser

If you have Onychomycosis, the medical term for fungal infection of the nails, you have probably tried many remedies. This is a very difficult infection to treat, especially in the toenails.

You may have heard that lasers are now being used to treat fungal nail infections. This is a relatively new nail fungus treatment which has definite potential. This article should give you enough information to know whether or not you might want to seek laser therapy for your nail infection.

laser-sight

There are a number of ways to deal with onychomycosis. They almost always include cutting away as much of the affected nails first.
These include:

Each new treatment has been hailed as a potential cure, only to prove less effective than hoped, or in the case of oral medicines, potentially dangerous because of the medications’ side effects.

toenail-fungus-picture

Many people wonder if whatever treatment they use is going to kill the fungus or just slow it down. Killing fungus is called fungicidal. Slowing it down is fungistatic. While many medications as well as lasers can kill fungus in a laboratory setting, essentially all therapy fails to kill all fungus in infected nails. That is why the infection comes back after treatment, or only improves the appearance of the nail without eliminating all traces of fungus.

Laser (Light Amplification by Stimulated Emission of Radiation) treatment

Laser is a form of light energy. The energy of the light is strengthened and sharply focused, so it can hit a narrow and specific target. When a laser beam of sufficient energy hits a target, it causes damage. Temperatures may rise at the site. This can kill funguses, and other organisms that cause disease. However, lasers do not have to produce heat to be used to treat disease. Their energy may have other specific effects.

 

Lasers have been in use medicine for decades. What was once thought of as a science fiction weapon or a national defense system is now used every day to treat patients. Lasers can do fine, delicate work as well as being used when a lot of energy is needed.

Some uses include:

  • Surgery – cautery of blood vessels, cutting of tissues.
  • Ophthalmology (eye) – treatment of retinal problems including damage from diabetes, aging, and problems due to vascular disease. Reshaping of the cornea to correct vision (LASIK surgery). This type of laser therapy must be exactly targeted and cannot cause excessive heat or anything that would damage the eye. It is very successful.
  • Dermatology – Removal of many types of skin bumps and lumps, from moles and scars to tattoos. Face peels and deeper layer laser therapy to erase wrinkles and treat acne. This is an area where many different kinds of lasers are used for different problems.
  • Podiatry – Used in surgery to cut through bone to fix deformities like bunions.
  • Other – Lasers can “pulverize” kidney stones and gallstones.

This is by no means a comprehensive list.

Lasers and onychomycosis

To penetrate into nails, lasers need to be within a certain wavelength. The longer the laser is used, the more power reaches the tissue. The power is the amount of light energy in a period of time, delivered to a specific spot. A laser has to be powerful enough to reach the tissues needing treatment.

Most of the lasers for toenail treatment generate heat. The heat does not instantly kill fungus but causes damage that leads eventually to its death. Heat in the surrounding area is monitored and cooling systems are employed to protect adjacent tissues.

Many lasers already used in medical practice are in various stages of testing and FDA approval for treatment of onychomycosis. Lasers already in use by dermatologists or podiatrists for other procedures can be used in what is called “off-label” treatments. These devices have been determined to be safe for other conditions, and it is not illegal to use them to try and clear up nail fungus. The best laser or lasers to use have not been determined.

The Type of Lasers Used to Treat Nail Fungus

Podiatrists are the main medical professionals who take care of toenail onychomycosis because they take care of feet. They have already been using lasers to treat plantar warts and ingrown toenails, among other problems.

As recently as 2009, there were questions about the amount of research needed to know if lasers are effective for onychomycosis and whether or not enough has been done.

Doctors who already had lasers were ready to use them to treat onychomycosis even without studies proving effectiveness. Researchers investigated the results from lasers already on the market, as well as testing lasers made specifically to treat nail fungus.

Certain lasers have been shown to inhibit the growth of a number of the funguses that causes nail infection, or even kill them in the laboratory, although they have not been proven to kill all the fungus in an infected nail.

One study done with what is called a long-pulse 1064 Nd:YAG laser was published in 2010. The research doctors examined and pared down toenails suspected to have fungus, but only the patients (72) with positive fungal cultures were treated with the laser. They also pretreated the nails to make them softer. They directed the laser in a circular pattern around each affected toe, for three passes. They did a treatment every week for four weeks.

Patients were rechecked after three, six, nine and twelve months. Follow up included re-culturing for fungus. Almost 96% were negative for fungus at three months. The three patients who were positive had repeat procedures, and all patients had no fungus on culture at six and twelve months.

Most of the patients treated this way had no pain or mild pain directly after the procedure. 38% had moderate pain briefly, and none had more than that. Most of the patients experienced less pain after the subsequent treatments compared with the first treatment. The patients were satisfied with their treatment.

These researchers also applied laser energy to the fungus they grew from the patients’ nails after the first session. Significantly less fungus grew after laser treatment. However, there was still some growth in the lab after laser.

There have been a number of other studies looking at how well other types of lasers treat onychomycosis. One used a Noveon laser. This device uses different frequencies than most of the other lasers. The two wavelengths are 870 nm and 930 nm, wavelengths that are reportedly lethal to fungi and safe for the tissues of the toe.

The authors of this study, which was published in the Journal of the American Podiatric Medical Association in 2010, say that the wavelengths studied have been shown to kill toenail fungus in a laboratory setting. They also mention a concern that other wavelengths like the 1064 nm wavelength have the potential to cause mutations in adjacent cells.

This study included people with toenails that either grew fungus on culture or appeared to have fungus on a stained preparation viewed under a microscope. There were 34 patients, 25 in the treated group and 9 in a control group.

There were four treatments of each affected toe. The first was given on day one, followed by days 14, 42 and 120. There were checkups at 60 days and 180 days when samples of the nails were taken for culture and/or microscopic staining and examination. Each treatment had two parts. The first was four minutes with application of both wavelengths. The second was with the 930 nm alone for another two minutes. Treatment was interrupted if a toe got too hot.

In between treatments, patients got a topical medication called terbenafine, and were still allowed to have the nails trimmed as necessary. Control patients got the same thing except that the lasers were set at zero power.

Cultures of toes treated with lasers were negative in 75% of toenails on day 60, after three treatments. Toenail samples appeared clear on microscopic examination in 64% of cases on day 120. On day 180, 39% of toenails were negative on culture and had at least three mm of clear nail growth. There was also improvement of the appearance of the onychomycosis in the treated nails. Pictures included with the study show significant improvement in the appearance of many treated nails. As determined by examiners, the difference in clear nail growth between the treated and control nails was statistically significant.

There were no serious adverse events. Patients experienced slight tingling or heat.

These investigators concluded that the treatment was safe, at normal physiologic temperatures, and like in the laboratory, toenails could be cleared of fungus with negative cultures in 75% of the nails after three treatments. The Nomir Noveon was approved for other uses in 2007, but has not yet been FDA-approved for onychomycosis.

Long-term follow up has not been published or reported in regards to any of the lasers used on nails.

Some studies have been published in journals or online. Others have not been published, but their findings were given to the FDA to get approval. The approved lasers operate at the 1064 wavelength. Differences between devices can include timing of pulses, and whether or not cooling is simultaneously applied.

While there are these other lasers in various stages of approval for treatment of nail fungus, the following four have been approved as of 2012 for “the temporary increase of clear nail in patients with onychomycosis.”

All of the following lasers are 1064 nm Nd:YAG systems:

They have not proved that they can kill or eradicate onychomycosis, but the FDA is satisfied that they do improve the appearance of fungus in the nails, at least temporarily.
The 1064 nm laser passes through the nail to kill the fungus in the nail bed. There is little pain, no serious side effects, and no long-term danger such as that caused by continual oral therapy. However, none has been proven to eradicate or cure the fungal infection completely or permanently.
While doctors and investigators who prefer the Noveon laser with its lower wavelengths, citing the higher wavelengths as possible causes for mutations (thus possibly causing damage to a developing fetus or cancer), there is no evidence that this has happened.

PinPointe™ FootLaser™

According to its manufacturers, the PinPointe FootLaser received FDA clearance for the temporary increase of clear nail in patients with onychomycosis on October 15, 2010, making it the earliest laser so designated.

The press release announcing the FDA clearance included a statement from Harvard University’s Chief of the Division of Podiatric Surgery, Dr. Adam Landsman. He said, “Toenail fungus is an incredibly embarrassing chronic condition affecting millions of people worldwide that genuinely impacts a person’s quality of life. For some with diabetes or immune disorders nail fungus can lead to serious health problems. With the clearance of the PinPointe FootLaser, patients finally have a pain-​​free treatment option that is more successful than topically-​​applied antifungal drugs, safer than oral medication, and less painful than surgical removal of the nail.”

A treatment lasts about 20 to 30 minutes. According to the manufacturer, the fungus may be killed after one treatment. The need for retreatment may occur because of reinfection from the environment. The treatment causes slight warmth, or possibly in a few patients, the sensation of a slight pinprick.

Treatment with the PinPointe FootLaser usually costs about $1,000.
Many podiatrists have given testimonials about this laser, and there have been case reports of its success. In one early trial, 87% of patients treated with this laser showed improvement.

According to an article in Podiatry Today, May 2010, early studies with the PinPointe FootLaser showed great promise.
One of the podiatrists writing this article described his own experience with the PinPointe FootLaser, which he said improved his onychomycosis, especially in the big toenail. He had no problems and believes it poses no health risks. He did this after locally applied therapy failed. While oral medicine helped, the fungus reoccurred, and he had side effects he attributed to liver or gall bladder problems.

To find a doctor in your area who uses the PinPointe FootLaser, go to this website:

http://nuvolase.com/patients/find-a-provider.

By entering your zip code you can find a local podiatrist who has this device.

Not all podiatrists or other healthcare providers list the cost of laser treatment on their website. You may have to call and ask. It is not covered by insurance. However, even when three treatments are needed, this may cost less than oral medication.

On the PinPointe FootLaser website, it is clear that this laser represents big business. A company called Cynosure has acquired the rights to distribute the laser all over the world. As of October 2011, they estimated that 100,000 treatments had already taken place. It can be used in the European Union countries, Australia and Canada.

The company’s press release says that a 12-month trial of 250 patients showed that 71.4% of the patients had continued clear nail growth after only one treatment. If clear nails can be growing for as long as twelve months, this treatment is much more successful than anything before.

Q-Clear™ Laser

The Q-Clear™ has been used in surgery and dermatology since 2003. It received FDA approval for treatment of onychomycosis in September of 2011. At that time, the FDA approval was for “the temporary increase of clear nail in patients with onychomycosis.”

While it may be able to kill fungus in the laboratory, there is frequently fungus remaining after treatment. All it takes is some remaining fungus to eventually cause the nail to return to its pretreated state over time.

The Q-Clear is an Nd-YAG laser that delivers high pulses of energy at 1064 nanometers. It can also deliver a 532 nanometer beam which is in the visible light spectrum and green in color, but this is not what is used for onychomycosis.

The Q-clear is not as large or expensive as older lasers used for other problems. It is compact and lightweight. It is also less expensive than older lasers. It is made by Light Age Inc., a company that has been making lasers for many medical applications as well as lasers used in other fields since it was founded in 1986.

The press release at that time stated: “September 28, 2011 – Light Age Inc., a Somerset, NJ based private developer and manufacturer of laser products, has received US FDA marketing approval for its Q-Clear™ laser systems for the treatment of onychomycosis. With it, fast, effective, low cost treatments can now become commonly available through dermatologists, podiatrists, and other professional healthcare providers.”

The main points are that the treatment is fast and low cost.

The company did their own study, which lasted 12 months and included patients of multiple ethnicities and both sexes. It was reported that 97% of the patients saw some clearing of their infection, with between 55% and 65% of the areas appearing clear. Light Age said that there was little to no reported pain and that all of the patients were satisfied. They also said, “…Q-Clear™ laser system has proven to be substantially effective in clearance of dystrophic nails having a clinically apparent diagnosis of onychomycosis.”

In this study, patients were treated once. No anesthesia was needed, taking less than five minutes per affected foot.

The Q-Clear has a red beam that allows the treating physician to precisely target the nails. The handpiece delivers the laser energy; the doctor moves the handpiece over the nails and circular beams hit the targeted area. Onychomycosis caused by all the normal fungi can be treated this way.

CoolTouch Inc. VARIABreeze ™ Laser

CoolTouch Inc. makes a laser called the VARIABreeze ™ which was approved for use on nails in November of 2011. The FDA clearance, the other 1064nm lasers, is for the temporary increase of clear nail in patients with onychomycosis. The company has been making lasers for medical uses since 1994, and has devices for treatment of skin wrinkles, varicose vein treatment, laser lipolysis (to reduce fat) and skin tightening.

According to the company, the CoolBreeze laser procedure takes twenty minutes. Patients treated with the laser can expect to see improvement in a few weeks. The company notes that it is safer than oral medication. The company also says that it is easier to have one treatment than to apply medication every day. CoolTouch describes their laser treatment as “…fast, safe, effective and painless…”

CoolTouch did studies on a 1320 nm, pulsed, CoolBreeze Nd:YAG laser to treat onychomycosis before their VARIABreeze laser was approved. This device is adjustable in terms of size of treated area, energy delivered, and a hand device allowing a cooling agent to be used. There may also have been studies of the VARIABreeze delivered to the FDA.

Using the older device, fifty-four toes (38 patients) that had culture-positive toenail fungal infections were treated with the laser. Toenails were treated at least two times in separate sessions with four weeks in between.

The patients in this study reported mild pain immediately after treatments. Patients were rechecked at four, twelve and twenty-six weeks after treatment. Patient satisfaction at week four was 3.4 (out of 5), at twelve weeks this number was 3.6, which is statistically significant. There was an increase in clear nail plate in 80% of the treated nails.

Only one patient reported significant pain in a big toenail; this pain was gone in two months.

The researchers for this study suggested that this laser could be used for two or three treatments, and that each treatment, even including all toenails and fingernails takes only 15 minutes. They could not determine whether or not the funguses, dermatophytes in this case, were inhibited or destroyed.

However, other researchers looked at the effects of fungus that was first wet under a vacuum or slowly cooled before being irradiated. The laser used was a CoolTouch, Q-switched, Nd:YAG laser, 1320 nm. This research showed that cooling, putting in a vacuum and using lasers can slow down the growth of the fungus. Slow cooling followed by rapid laser treatment reduced the rate of fungal growth the most. It is not entirely clear how this information can be helpful to the practicing doctor, but these kinds of studies helped companies like CoolTouch design their lasers to treat nail fungus.

One podiatrist in Sacramento, California who had been using the similar CoolBreeze laser before the CoolTouch was approved said the laser treatment was effective in 80% of cases that he treated. He says that the system monitors the temperature to make sure the tissues do not get too hot.

This doctor noted that the toenail does not become clear at the time of treatment. Once a significant amount of the fungus is killed, the new nail must grow out. Each person’s nails grow at a different rate, so that results will not become completely visible for six to twelve months. However, clear nail growing out can be visible as early as eight weeks after the procedure.

This particular doctor offers three treatments beginning at $275, which is not covered by insurance. The cost varies depending on how much nail needs to be cut back before the laser treatment. He will give patients 75% off if they need re-treatment in the future.

He also states that results are much better if you use topical treatment on the nails afterwards and make sure that there is not a good place for the fungus to regrow. For example, diabetics with high blood sugars are making a good home for fungus in the nails and need to control their blood sugar to keep nail fungus away. Topical preparations should be continued and shoes sprayed with antifungal medication.

This general advice can be applied to all laser treatments of onychomycosis.

Cutera Genesis Plus™ laser

This company received FDA approval in March 2012 for its Harmony (XL) multi-application, multi-technology platform laser system. While it is a 1064 nm Nd:YAG laser, it also has a tip (called a KTP tip) which uses a shorter wavelength of 532 nm. The company that makes this device, Alma Lasers, Inc., says that the shorter wavelengths cause tiny cavities in the nail which may help the 1064 nm laser get into the fungal colonies under the nail. The company also says that the 532 nm wavelengths are absorbed by red and brown pigment in the nail. These discolorations can be caused by fungus, and treating them with the laser may improve the appearance of the nails.

They suggest that the lower wavelengths be used first to help eliminate the discoloration of the nails and cause mechanical damage to the nail, so that the 1064 nm laser can get more effectively under the nail to the nail plate, where they say the fungus is “deactivated.”

The Genesis Plus is a free-standing, light and portable machine that can be moved from room to room.

This laser has already been approved for many skin conditions, including removing deep pigmented spots and tattoos. The two different wavelengths mean that it can remove more colors in tattoos. Black, blue and green can be removed with the 1064 nm wavelength, while red, orange and yellow can be removed with the 532 nm wavelength.

One small study was done by a podiatrist using the Cutera Genesis Plus on all the toenails of seven patients, who had culture-proven fungal nail infections. The handpiece of the device can be set to deliver as many as 100 pulses each time it is passed up and down and side to side over the nails. Each nail received four passes. The big toenail received 100 pulses. The other 4 nails received about 100 pulses together.

There were two treatments done for each patient, six weeks apart. Each session lasted about 15 to 30 minutes, again treating all the nails on each foot. No anesthetic was necessary, and there were no observed side effects.

Success was documented by the use of digital photography, high resolution, with photos taken before treatment, at week six and twelve post first treatment.

70% of the treated nails showed improvement after the two treatments. 71% of the significantly to severely affected nails showed improvement while 67% of the mild to moderately affected nails showed improvement.

This small study looked at cosmetic results only. 70% of their patients showed improvement after two laser treatments with no side effects.

The podiatrist who reported these cases charges a different amount, depending on how many nails are involved. Including evaluation, this can be $800 for five toes and $1,000 for ten toes. $100 of these charges can be billed to insurance as podiatric examinations. Follow-ups can also be charged at $50 to insurance. But the laser therapy is essentially never covered by insurance.
A second laser treatment, if needed, would only cost $100. This is at a Southern California podiatry clinic outside of Los Angeles County.

Cost of laser treatment of onychomycosis

Cost to treat nails depends on many factors including:

  • How many nails are involved.
  • How thick they are and how much surgical paring has to be done first.
    What type of laser is used.
  • The area of the country you live in and the cost of medical care there in general.
  • Whether or not the goal is to completely clear nails, if this is possible, as opposed to improving their appearance.

Quotes range from treatment starting at $275 to $1,100. Most people with affected toenails that hav