Laser treatment for nail fungus

ooh now don't tempt me Robert

 

Well and well and well. I guess there are no answers.

Cheers

 

Any updates on research to support the efficacy of laser treatment?

 

I've had a couple of patients have it done in Sydney, seen one review at 4 months post laser thus far - there was some distinct proximal nail colour change 4 months post laser, and the nail was definitely much better attached to the bed underneath. I have no idea what this actually means, however I am assuming we are seeing some form of change as a result of the laser. Will continue to monitor over the next 8 months.

 

Hi, Paul, I wonder what laser machine do you use and how much do you charge for the treatment (in Sydney)?

 

I have a facebook page with images on it that show the kind of changes you will see. Just look up The Newcastle Nail Laser Centre in facebook.
Paul if you want you can send me images and I can give you the benefit of my experience so far if you think it will help you.

 

Hamish,

Do you use any sort of anaesthetic when you prepare the nail before the laser? It's obviously needed to take away as much as the bad before treatment but looks quite painful.

 

Feety, no analgesic necessary and there should be no significant discomfort from (or during) the debridement either. Choosing the right equipment and using the right technique and optimising skill levels helps too.
The laser can generate some tenderness on occassion due to pre existing inflammation, or a lack of toebox space (in-shoe trauma). Generally the patient will find the removal of the diseased nail and the callus/hyperkeratosis more comfortable.

 

Thanks hamish!
I wish I could afford laser but for now hoping if I see a chiropodist they will be able to remove as much bad as possible, I think this would help!
Do you recommend a topical treatment to apply after the laser while waiting for the new nail to grow?

 

Dear international colleagues:

In the last 4 months, I have received many worldwide inquiries from outside of the United States, concerning potential purchase of a Noveon laser for the treatment of Onychomycosis.

With this interest, my team has generated a group of prospective foreign distribution partners that will assist us in regulatory and registration efforts in the EU, Asia, South America and other areas around the globe.

Of interest to the international community, the Noveon NailLaser is a CE Marked Laser Medical Device that complies with RohS. The manufacturer of Noveon NailLaser is ISO: 13485 certified.

For these worldwide requests, we have established an international web site www.noveoninternational.com to begin categorizing and harnessing this interest by geographical area, to expedite distribution.

I would request that any worldwide party that desires more information on: (1) The Noveon NailLaser and (2) its scientific and clinical data, can now find this information at our new international web site.

Noveon Technology:
http://noveoninternational.com/consumer/how-the-noveon-naillaser-kills-nail-fungus

Scientific Papers:
http://noveoninternational.com/consumer/noveon-scientific-papers

Before and After Pictures:
http://noveoninternational.com/consumer/before-and-after-clearer-nails-with-noveon-naillaser

Please email me through the contact page in the web site, if you are interested as (1) a customer or (2) a distributor, and we will quickly get back to you with information, as to where we are with regulatory and distribution possibilities in you part of the world.

International Contact Page:
http://noveoninternational.com/consumer/consumer-inquiry


Best regards,

Eric Bornstein DMD
Chief Science Officer
Nomir Medical Technologies
ebornstein@nomirmedical.com
www.noveoninternational.com
Cell: 508-380-9866

 

Dr.Bornstein;
What is the status of the FDA approval for laser system in regards specifically to the treatment of onychomycosis?

 

So far to my limited knowledge PinPointe is the only device of this kind to be granted FDA clearance for onychomycosis.
Some imagery of my work can be found a thttp://www.facebook.com/album.php?aid=286641&id=165514464274

 

Thank you, I was specifically looking for information on the nomir laser system> I have seen a lot of info on the pinpoint system. Im now curious about Dr. Bornsteins nomir system.

 

poddoc:

Thank you for the inquiry.

The Noveon currently has two (US) FDA approvals for Podiatry, Dermatology, ENT and Plastics.

1) http://www.accessdata.fda.gov/cdrh_docs/pdf7/K071815.pdf

2) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29588

We have applied for a 510(k) approval for Onychomycosis, and are 2/3 of the way through the statutory application process.

We expect to hear from the FDA by the end of February.

I will certainly update everyone before then, if the approval comes in early.

Best regards,

Eric Bornstein DMD
Chief Science Officer
Nomir Medical Technologies
ebornstein@nomirmedical.com
Cell: 508-380-9866

 

I'm not here to sell anybody anything, but I've been in the cold laser business for many years. And I know about the hot lasers that are now FDA approved for onychomycosis. I also know how expensive they are. But did you know you can get an 'off the rack' similar laser for under two thousand dollars? As far as I can see, all that big expensive fungal laser is, is a Q-Switched 1064/532 laser that is commonly used to removed tattoos! You may need a cooling machine with it, like a Zimmer, but I know podiatrists who use this laser without the Zimmer. In fact, this Q-swiched laser can be bought from just about any dental laser company since dentist use it with a similar shaped cone that comes to a point (laser head).
Unless your board specifically says you must use an FDA approved laser, then why pay zillions for the privilage if a much cheaper version would do? And, you can own it for almost nothing! Not rent. Not lease. OWN!
Again, Idon't sell these, but I've been asked to look into it, so I did.
By the way, from my handle you'll know I'm a chiropractor. I have no use for hot lasers other than possibly a class IV which is used to treat deep tissues--as in discs for back pain.
The above is just my opinion.

 

HI, ChicagoChiro: have you used the Q-Switched laser to treat fungal nails? What laser do you use for back pain treatment?

 

As a surgical podiatrist working within a large multispecialty surgical practice, I would only utilize an approved laser system for podiatric useage. Granted the other types of lasers may work as effective however, living with our litiginous society you are risking alot not using one of the approved laser systems. Not to mention evidence based medical practices... using a system designed for the dental field would and should be frowned upon.
If these systems ie; pinpoint and noveleon have the results reported, you willl not only reap the financial rewards, but the rewards of knowing you are helping your patients and your own reputation.

 

Hi Charlie,

Aside from chiropractic techniques (adjusting), I also use a cold laser to treat back pain. The laser helps reduce inflammation and pain, plus it hastens the recovery period.
No, I have not used a Q-Switched laser to treat fungal nails. I don't know any chiropractors who treat onychomycosis. Along with laser therapy to treat fungus, there are other procedures such as debriding and prescribing medication that chiropractors do not do. But I have heard of other podiatrists using the Q-switch laser to treat fungal nails--and with similar success as the FDA approved lasers.
Your colleague who mentioned only using FDA approved lasers may have a point--noting legal ramifications if you don't. Nonetheless, I would pose this question directly to your licensing board, that is, whether or not you can use a similar, but not FDA approved laser. From what I read, the companies who did have their lasers FDA approved are also politically active and I can see the potential for a conflict of interest in their answer.
I should also note that physical therapists and chiropractors have been using non-FDA approved lasers for years, and, to my knowledge, without incident. Of course the lasers we use are class IIIB or less, not hot lasers as are the FDA approved fungal lasers. The FDA just started approving cold lasers for carpal tunnel syndrome less than ten years ago. But therapeutic cold lasers have been in use for over thirty years.
Side note: A number of podiatrists are using cold lasers to treat onychomycosis and are reporting the same results as with a hot laser. So the question is this: Does the effectiveness of laser therapy on fungal nails have more to do with the laser wavelength (color) or heat?

 

ChicagoChiro:
There are two types of laser used to treat onychomycosis today: one is long pulsed YAG (1064nm) laser (which is a millisecond laser), the other is Q-Switched YAG laser (which is nanosecond). The latter doesn't produce much heat because of its extremely short pulse width. So far I noted only one Q-Switched laser manufacturer has been promoting its laser for this particular purpose. In vitro study (2008) showed Q-Switched laser was effective in suppressing xxx fungus. However why most of the manufacturers chose long pulsed instead of short pulsed (QS) laser?

The approval by the FDA is sometimes confusing. The approval may simply mean that the device is safe to use on human and it has nothing to do with the therapeutic effectiveness.

If you are not concerned about safty then one option is to use a magnifier to focus sunlight onto the toenail. I heard it worked well.

I also have a cold laser (50mw). It's very good for muscular pain. I don't think it can be used to treat onychomycosis due to its low power output.

 

plain and simple reply - been using pinpointe and seeing good results with it. after care is very important to reduce risk of reinfection. not really interested in trying to make other pods 'believe', just interested in offering patients a solution to their problem. easy peezy.

 

The only laser specification that dictates tissue penetration is wavelength (nm/color). Slightly increased power may shorten treatment times to a small extent. The nail bed isn't that deep and neither is the fungus you can see, so even the light from a cold laser can quickly reach your target tissue.
Bottom line, I'm not sure what part of the laser treatment works best (light or heat) and whether or not laser therapy would work independently of ancillary treatments. Podiatrists I know have reported good results when they just used a cold laser. The big problem is that it takes over a half a year to find out, and that's only with patient compliance and dedication.

 

Gentlemen:

I would suggest some reading on your part, to further discern the photobiology employed by the various syetems available in the market.

http://www.noveoninternational.com/consumer/noveon-scientific-papers



Specifically by wavelength and system:

Noveon Laser

http://onlinelibrary.wiley.com/doi/10.1111/j.1751-1097.2009.00615.x/abstract

Abstract
We examined a laser system (870 and 930 nm), employing wavelengths that have exhibited cellular photodamage properties in optical traps. In vitro, with 1.5 cm diameter flat-top projections (power density of 5.66 W cm−2), at physiologic temperatures, we achieved photoinactivation of Staphylococcus aureus, Escherichia coli, Candida albicans and Trichophyton rubrum. Using nonlethal dosimetry, we measured a decrease in trans-membrane potentials (ΔΨmt and ΔΨp) and an increase in reactive oxygen species (ROS) generation in methicillin-resistant S. aureus (MRSA), C. albicans and human embryonic kidney cells. We postulate that these multiplexed wavelengths cause an optically mediated mechano-transduction of cellular redox pathways, decreasing ΔΨ and increasing ROS. The cellular energetics of prokaryotic and fungal pathogens, along with mammalian cells, are affected in a similar manner when treated with these multiplexed wavelengths at the power densities employed. Following live porcine thermal tolerance skin experiments, we then performed human pilot studies, examining photodamage to MRSA in the nose and fungi in onychomycosis. No observable damage to the nares or the nail matrix was observed, yet photodamage to the pathogens was achieved at physiologic temperatures. The selective aspect of this near-infrared photodamage presents the possibility for its future utilization in human cutaneous antimicrobial therapy.

Long pulsed Nd:YAG:

http://pdfcast.org/pdf/laser-antisepsis-of-phorphyromonas-gingivalis-in-vitro-with-dental-lasers

Abstract
It has been shown that both pulsed Nd:YAG (1064nm) and continuous diode (810nm) dental lasers kill pathogenic bacteria (laser antisepsis), but a quantitative method for determining clinical dosimetry does not exist. The purpose of this study was to develop a method to quantify the efficacy of ablation of Porphyromonas gingivalis (Pg) in vitro for two different lasers. The ablation thresholds for the two lasers were compared in the following manner. The energy density was measured as a function of distance from the output of the fiber-optic delivery system. Pg cultures were grown on blood agar plates under standard anaerobic conditions. Blood agar provides an approximation of gingival tissue for the wavelengths tested in having hemoglobin as a primary absorber. Single pulses (Nd:YAG: 100-ìs; diode: 100-msec) of laser energy were delivered to Pg colonies and the energy density was increased until the appearance of a small plume was observed coincident with a laser pulse. The energy density at this point defines the ablation threshold. Ablation thresholds to a single pulse were determined for both Pg and for blood agar alone. The large difference in ablation thresholds between the pigmented pathogen and the host matrix for pulsed-Nd:YAG represented a significant therapeutic ratio and Pg was ablated without visible effect on the blood agar. Near threshold the 810-nm diode laser destroyed both the pathogen and the gel. Clinically, the pulsed Nd:YAG may selectively destroy pigmented pathogens leaving the surrounding tissue intact. The 810-nm diode laser may not demonstrate this selectivity due to its longer pulse length and greater absorption by hemoglobin.


Q-Switched Nd:YAG:

http://www.springerlink.com/content/kgj1542505523j17/

Abstract
The effects of various laser wavelengths and fluences on the fungal isolate, Trichophyton rubrum, were examined in vitro. Standard-size isolates of T. rubrum were irradiated by using various laser systems. Colony areas were compared for growth inhibition on days 1, 3, and 6 after laser irradiation. Statistically significant growth inhibition of T. rubrum was detected in colonies treated with the 1,064-nm Q-switched Nd:YAG laser at 4 and 8 J/cm2 and 532-nm Q-switched Nd:YAG laser at 8 J/cm2. Q-switched Nd:YAG laser at 532- and 1,064-nm wavelengths produced significant inhibitory effect upon the fungal isolate T. rubrum in this in vitro study. However, more in vitro and in vivo studies are necessary to investigate if lasers would have a potential use in the treatment of fungal infections of skin and its adnexa.



Evidence Based Medicine Discussion for Laser/Onychomycosis:

http://www.podiatrytoday.com/emphasizing-importance-ebm-when-it-comes-laser-care-onychomycosis


Best regards,

Eric Bornstein DMD
Chief Science Officer
Nomir Medical Technologies
ebornstein@nomirmedical.com
www.noveoninternational.com
Cell: 508-380-9866

 

I'm glad you're getting good results.
Again, for those who are thinking of using a generic version (exact same specifications of the absurdly expensive lasers), I would first ask your state board and malpractice insurance carrier. Either way, it's the doctor who has to properly handle the equipment no matter which one they use. In my opinion, they can safely operate an off label laser with the proper training. Likewise, it doesn't matter which scalpel you use--it's still you who has to do the cutting.
Maybe it's just me, but I've always been more than a little suspicious of big box medical equipment dealers/manufacturers who offer 'best practice' suggestions and try to instill fear in a potential customer, "You might get sued if you don't use our product."
Check it out for yourself.
I'm a licensed human chiropractor and I've been involved with cold lasers for years. I've mostly used non-FDA approved lasers in my practice--and never got sued for doing it. In fact, I hear from thousands of chiropractors who have also used non-FDA approved lasers and I've never heard or seen a report where anyone was sactioned by their state or sued because of it.

 

Thanks ChicagoChiro for the info. Any chance you could provide more details about the cold laser (e.g., wave length, power output, irradiation time...)

 

I agree with you. It's not just you, ChicagoChiro.

 

ChicagoChiro: here is a good example: http://bellredfootdoctor.com/pinpointelaser.html

Please read the last paragraph.

 

I just came across this website: http://www.tritonlasercenter.com/

Here is the statement of Triton Laser Center regarding Patholase PinPointe Foot Laser:

"Dear Patients,

Due to the ineffectiveness of the laser treatments, which averaged a cure rate of only approximately 36% of all toes treated, we have decided to terminate treatment with the laser. The laser was returned to Patholase (providers of PinPointe Foot Laser) on 11/30/10, as it was their proprietary product.
For those patients who did not see improvement after the first treatment, we found very little success (less than 2%) with subsequent treatments. One patient was even treated a total of three times without any success. Since Patholase removed its laser from our facility, we are no longer able to provide any laser treatment. The removal was abrupt and hence we were not able to extend the period of time for follow up treatment as we anticipated. There are no longer any other providers of PinPointe Foot Laser here in the Northeast Ohio area. We suggest that if you are interested in any further laser treatment of any kind (Nd:Yag, cold laser, etc…), you obtain from the treating doctor the actual cure rate data and not rely on unsubstantiated claims of success.

We followed standard, recommended protocol for the debridement and laser treatment of our patients with photo documentation of the toenails/fingernails before and after treatment. We can no longer recommend this laser treatment option, as a result of the significant differences in our patients’ actual responses as compared to the treatment expectations. Even temporary improvement in nail infections does not seem to justify the cost of this procedure. We encourage patients to discuss oral antifungal therapy with the close monitoring of liver enzyme levels by a dermatologist, podiatrist, or the primary care physician for the current treatment of onychomycosis.


Sincerely,


Triton Laser Center"

Very interesting !!!

 

Thank you, Charlie01. I REALLY enjoyed reading the last sentence! This is exactly the point I was making. Note they said, "beware" but never said it was illegal to use other types of lasers (cold lasers, K-laser) to treat nail fungus.
I'm not at liberty to mention my name or company, since I do sell cold lasers for therapeutic use (musculo-skeletal conditions), but I have had several podiatrists buy them. I don't know for sure if they're using our cold lasers to treat onychomycosis, but a number of them reported good results along with debridement and medication. If they did use ours to treat fungal nails, that would be an off label use and completely up to them.

This is unrelated to this forum, but during the past eight years or more, chiropractors and physical therapists have been bombarded with direct mail advertisements from companies who make spinal decompression tables. These tables, which are little more than high priced traction devices used to treat disc herniations, range in price (not making this up) from as little as $6500 to over $120,000! I've taken several seminars from various manufacturers. Bottom line: there is NO difference in clinical outcome regardless of how much you paid!
The machines that cost over a hundred thousand simply have more 'tin' to fill up the room.
During one of our conventions I stopped by the booth of one of these overpriced manufacturers. The decompression equipment was enormous, with a huge table and lots of high tech looking computer modules. I asked the salesman what the difference was between his hundred thousand dollar unit and the sixtyfive hundred dollar unit. Do you know what his reponse was? "The cheaper units don't have the "WOW" factor!" Meaning, you can't get a patient to pay as much for each treatment with a cheaper unit even though it does the same thing. I can't express how embarrassed I was at that moment. Not for him (he was out to sell me) but for my profession. It was an insult to every chiropractor. It was also a affront on any potential patient. Everyone deserves and shoudl expect an ethical practitioner.
An interesting side note is that National College of Chiropractic (now called National University of Health Sciences) in Lombard, IL, uses the lower priced spinal decompression units in their clinics. I went there. I visited their main clinic in Lombard. I talked to the student chiropractors and the clinic director. All were pleased with the less expensive units. The clinic director even told me the college bought those units since they needed several of them (I think about a dozen) and couldn't afford to spend over a million dollars to outfit all of their clinics.

 

Some podiatrists use LLLT to treat soft tissue injury or tendonitis. I don't think they use LLLT for onychomycosis.

 

Here is some info regarding PinPointe:

"The PinPointeTm FootLaserrm is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.)."

Here is the original 510(k) approval document: http://www.accessdata.fda.gov/cdrh_docs/pdf9/K093547.pdf

Look closely at the wording: temporary increase of clear nail. So what the laser does is to make the discoloured nails temporarily clearer rather than killing the fungus and curing onychomycosis.

 

Exactly right. So tell me why a highly trained podiatric surgeon cannot make a choice to use a generic, non-FDA approved laser to do the same thing at a fraction of the cost? It's the doctor who decides treatment, not medical device manufactuers or drug companies. As long as the medical device does the EXACT same thing, why not use that? Like I mentioned earlier, it is a good idea to check with your state board and your malpractice insurance carrier first. That aside, I can't see spending a fortune, or for that matter, charging a fortune for a treatment that isn't consistent. From what I read, the laser treatment for onychomycosis isn't covered by insurance--so you don't even have to please the insurance company! It's a cash procedure. It's just between you and your patient.

 

Can't say I have the same level of poor results myself, my planimetry results indicate far better. I have been using a PinPointe for about a year and a half. One needs to understand the technique of use of hte equipment well and in my opinion have good debridement technique, patient educaton on footwear can be important for impact tissue vitality reasons too. A magic wand it is not.

My understanding of the use of the word TEMPORARY is for sound legal reasons and most companies have to incluse some degree of circumspection. If one was to claim permanent removal then it could/would imply the person could never contract an infection in that nail ever again.

As for the PinPonte device I think it is considered to be "optimised" for its use with onychomycosis so the laser energy chain burst is specific for its purpose and does not cause a burn to the tissues. As for the FDA thing, its lable state it is cleared for use on o/m not approved by FDA. I think for the time being it is th only device of its type that can make this claim within the FDA regulations.

 

PinPinte temporarily makes fungus infected nails clearer. The FDA document didn't mention whether PinPinte killed fungus that infected the toenails.

 

Following is a list of "fungal nail lasers" that have been used "successfully":

(1) Long pulsed Nd:Yag based laser (1064nm, this type of laser is usually used for hair removal and spider vein treatment):
- PinPointe (need proper debridement prior laser treatment)
- Fontona Podiatry Laser (35ms pulse width, 4mm spot size, 35-40J/cm2, no debridement required?)
- Palomar Lux
- Aerolase (0.65ms pulse width, 2mm spot, 223J/cm2 ???)

(2) Diode laser (infrared and near infrared):
- Cool Touch Cool Breeze (1320nm, spot size 3-10)
- K-Laser (970nm and 800nm, output power 0.5-12W, continueous wave, pulsed 1Hz-20kHz)

(3) short pulsed Nd:Yag laser (Q-switched, 1064nm, this laser is usually used for tattoo removal):
- Q-Clear Q-switched laser

(4) Misc:
- CO2 laser
- DIY home treatment: I've seen somebody claiming successful treatment using a magnifier to focus sun light on the fungal infected toenails.

It seems to me any laser that is able to produce sufficient power output and to penetrate through the nail plate may be used "successfully" in the treatment of fungal nails.

"No matter if it is a white cat or a black cat; as long as it can catch mice, it is a good cat. "

 

Right on! I agree with everything you said.
As I mentioned in an earlier post, the thing which made me skeptical about absurdly priced therapy devices are the companies who try to sell chiropractors grossly over-priced spinal decompression tables, with the highest ones being over $120,000.00. Not making this up. There are spinal decompression tables (used to treat disc herniations) which cost $6500.00 and do the EXACT same thing. However, the absurdly priced decompression table companies use different scare tactics. Instead of saying 'you must use an FDA approved device to avoid lawsuits', they try to entice the chiropractor into buying the expensive table saying, "Ours looks impressive. You can't charge $300.00 per treatment for 15 sessions with a cheap looking table even if it does do the same thing." In other words they're selling the 'WOW' factor. I was embarrassed to be in the company of that salesman who said that, knowing some of my colleagues lapped it up.

 

Hi, harmish, I wonder if you file down the nails that are not thickened as well before laser treatment in order to reduce fungal load.

 

I have no problem with using laser to treat fungal nails once i see the randomised studies. I also do not have any problem paying $15000:00 for the machine. I DO however have a problem with having to pay the company a monthly fee of at least $4000:00 or $200.00 per client before you put on your own fees. Lets not encourage ripping off the unfortunate people who have fungal nails to pay some greedy entrepenour. Lets get real - Someone else will bring out a similar laser and sell it for what it is worth and the people left with Pinpointe Laser will be left paying per patients .:boohoo:

 

I responded to the news of the "temporary clearing" of the Pin Pointe document with the word "crooks," so I think that's probably why it was censored.

I didn't make it clear that I was referring to the manufacturer/promoter/distributor of the product. Here in New Zealand I understand they are offering exclusive "territories." If you are the first to get a laser, you can have an exclusive in your area.

Charging a high monthly fee, or use fee, is just taking advantage, using a hard edged "business" model for medical care. If it were an essential service, it would be seen as heartless profiteering. Since it's cosmetic, I guess nobody cares.

All the lasers kill fungus. You only see mushrooms growing in the shade. (DUH!) The CO2 method makes pin holes in the nail plate for administering liquid antifungals.

You probably don't want to use this method. It's tedious, requiring several treatments for nail clearance. And it smells. Even with a large commericial vacuum exiting the smoke plume directly outside, your room still smells like burnt hair. You have to use a lot of aerosol scent.

Cheers

 

I'm not hear to get points from anyone, but I wish the chiropractic forums were as informative and as professional as this podiatry forum. The above poster from New Zealand gave excellent information and told it like it is.
There's nothing wrong with being flip once in a while, but the chiropractic forums I joined (then quit) are all jokes.
From my handle you know I'm a chiropractor and I came here to learn about the latest in podiatry. What a pleasure it is to come here.

 

Have had Omega LLR training seems useful for most podiatry problems.
Also impressive from a patients view.
Use it following nail surgery for good results not convinced on mycosis.
Don't mind parting with the fee!! oh technology is a wonderful thing!!!!igs: