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Great . . . . thanks Paul, it will be interesting to see your results.

Do you think might be useful at this stage of investigating the efficacy of light for treating onychomycosis to do more basic science?

What I have in mind is taking severely infected nails (post TNA material) cutting them into say 5X5 mm chunks, doing a culture, irradiating with different doses and then re-culturing to attempt identifying what the dose relationship might amount to also possibly if there is differential effect on different dermatophytes.

To my knowledge this has not been done with nail material.

Cheers

Martin


Foot and Ankle Clinic
1365 Grant Ave.
Winnipeg Manitoba R3M 1Z8
phone [204] 837 FOOT (3668)
fax [204] 774 9918
www.winnipegfootclinic.com

The concept as far as I can see is purely thermal: i.e. destruction of material. The guides seem fairly set for each laser - and as far as I have seen you set them at an output which seems tolerable to the patient without causing marked pain. After delivery of the total dose you can physically feel the heat on the toenail and the patient starts to reports some discomfort. From my clinical experience looking at the 1064nm laser so far it would seem that this "discomfort" is somewhat a desired reported result.

Technically you can increase the power output on all the lasers I have seen and you can burn tissue very easily. It cauterizes tissue very well and I can see applications beyond fungus and warts, even as far as partial nail avulsions and cautery during foot surgery.

I think your idea is potentially interesting!

Dear International Colleagues and International Distribution Agents:

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As you know, Nomir Medical is the developer and manufacturer of the sole and exclusive medical laser in the world that has published, peer-reviewed, scientific data to back up its claims in the field of onychomycosis (toenail fungus).

If you have a desire to distribute or purchase the Noveon Nail laser outside of the United States, please contact Jack Kay, so that he can determine how best to proceed with you.

Best Regards,
Dr Eric Bornstein
Chief Science Officer
Nomir Medical Technologies



Jack Kay, PhD
President and CEO
Nomir Medical Technologies, Inc.
4 Station Plaza
Woodmere, NY 11598
www.noveoninternational.com
Office: +1.516.54NOMIR, Ext. 100
Fax: +1.516.545.0300
Cell: +1.617.875.1472
mailto: jack@nomirmedical.com

Press Release:
Nomir Medical Announces 510(k) Application to FDA for the Temporary Increase of Clear Nail in Patients with Onychomycosis (Toenail Fungus) with the Noveon™ Laser

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Which is the best protocol for laser treatment in terms Of number Of application and distance from each application?
How many Joules must be' delivered for cm2?

Gianluca

At last some common sense around fungal nails, improve the nail environment first then there is a chance, with tenacity, that the fungas won't be able to survive.
I file them down if they are thick,apply something to waterproof the nail and use lavenda oil. Remove whatever is causing the pressure on the nail and causing the distortion.
One Dermatologist who is very keen to use his "laser" on all sorts admitted that the nails he treated with the laser appeared to have lost the fungas but still remained distorted ! and the patients were coming back when the fungas took up residence again ! he was after some advice around prevention of reinfection.

Hi Tess,

I agree, environmental factors should be considered as lower limb biomechanics and footwear requires examination in cases of trauma induced nail pathology and subsequent infection of OM. We know that dermatophytes are opportunistic pathogens and will take advantage of a traumatised/compromised nail plate. However, other variables such as systemic (congenital, hereditary or acquired) disease associated with compromised immunity and drug side effects/reactions should also enter the equation, IMO.

Can you expand on your clinical reasoning for this regime?

Cheers,
Bel

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Hi Bel,
I started using Lavendar oil when I found out it had fungastatic properties comparable to most other topical treatments on the market. Keeping water out ,Cleaning with Alc. wipes then applying the oil changes the environment that dermatophytes need to grow.
I can't remember where I saw the research as it was many years ago. I know there are some warnings around the use of Lavendar oil during pregnancy and with young boys.
I have been doing this for 25 years after many arguments with (friendly discussions) GP's dermatologists about the overuse of referrals for pathology tests and prescriptions of liver toxic drugs such as grisiofulvin,
One lecture I attended in Wollongong had a Dermo stand up and say he prescribed Grisofulvin for one of his partner's wife, to treat her fungal nail and then bumped into her in the street in the following weeks when he noticed she had developed Jaundice. He actually joked about it ! You could call this over kill medicine.
thanks for being interested in my rant.

Newly Approved Laser Systems for Onychomycosis
Aditya K. Gupta and Fiona Simpson
J Am Podiatr Med Assoc 2012;102 428-430

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Hi Tess,
Thanks for taking the time to reply. Please don`t take any questions on my part as an attack on your clinical skills; I am genuinely interested in exploring the reasons why many pods choose to use the perceived `natural` route in prescribing distilled essential oils for dermatological complaints, as opposed to evidenced based products. Good to see FDA approval for laser tx.

Did this piece of research state HOW it compared to other topical anti-fungals, with regard to efficacy and safety?

Interesting. `Tis true that there are anti-fungal products available which claim to make it difficult for dermatophytes to thrive by altering the environment or pH of the nail apparatus. However, the trials are questionable in methodology and recruitment. It would be useful have access to the research that you refer to. A cursory search on the `net found this article which indicates that the mode of action is fungicidal due to the active component Linalool, which is a terpenoid. Terpenoids are also the anti-microbial properties in tea tree oil and are known sensitizers for contact dermatitis, increasing in risk of adverse reaction with oxidation. Wiki states: Linalool gradually breaks down when in contact with oxygen, forming an oxidized by-product that may cause allergic reactions...

So, yes. You`re right when you say;
As with all other essential oil remedies, the above article raises concern for irritant or allergenic skin reactions with the use of lavender oil. This warning is echoed in `Potential of plant oils as inhibitors of Candida albicans growth` , which states All the oils inhibiting growth showed fungicidal activity except Jasmine and Lavender oils. However, if they are to be considered in topical preparations a careful exploration of their probable irritating and other undesirable effects in humans need to be undertaken. So, not only could lavender oil induce contact dermatitis, it does not appear to be effective in OM associated with Candida species.


I don’t understand what you mean by `overuse of referrals`. Do you not agree that microscopy and culture is required for pathogen specific treatment?

With respect, Griseofulvin has been declared safe through many RCT`s. This article concludes; No cases of acute liver failure or chronic bile duct injury have been reported due to griseofulvin. With regard to Hepatotoxicity it states;Transient mild-to-moderate elevations in serum aminotransferase levels occur in up to 5% of patients treated with griseofulvin, but these abnormalities are usually asymptomatic and resolve even with continuation of the medication. Clinically apparent hepatotoxicity is rare. The liver injury from griseofulvin is typically cholestatic and usually arises within the first few months of therapy. Signs of hypersensitivity such as fever, rash and eosinophilia are rare. Case reports of griseofulvin induced liver injury have all been self-limited, recovery requiring 1 to 3 months. ......

There are many drugs that have an adverse effect on the liver, see here. In fact, Hepatotoxicity is the most common reason for a drug to be withdrawn from the market. Examples of drugs that more commonly cause elevations of liver enzymes in the blood include the statins, antibiotics, some antidepressants, and some medications used for treating diabetes, tacrine, aspirin, and quinidine. However, those elevations of enzymes are usually considered clinically safe and liver function tests are performed to monitor the levels, as with oral anti-fungal treatment regimes.

One oral fungicide that has previously received bad press with associated hepatotoxicity is terbinafine. This has been also been declared safe after many trials, such as these;

Postmarketing surveillance of oral terbinafine in the UK: report of a large cohort study

Safety and efficacy of oral terbinafine in the treatment of onychomycosis: analysis of the elderly subgroup in Improving Results in ONychomycosis-Concomitant Lamisil and Debridement (IRON-CLAD), an open-label, randomized trial.

Ultimately, it is up to you how you incorporate evidence based medicine into your practice. However, I`m sure that you would agree that it is of uppermost importance that we utilise products that have been proven to be effacacious, safe and justifiable in the unfortunate incident of patient litigation. Just a thought.

That said, if you can locate the research that you referred to, I would certainly be interested in reading it.

Cheers,
Bel

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Hello, thanks for the information posted here. An interesting topic and good to see some open debate.

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Laser and light therapy for onychomycosis: a systematic review.
Ledon JA, Savas J, Franca K, Chacon A, Nouri K.
Lasers Med Sci. 2012 Nov 20. [Epub ahead of print]

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I have had a patient who paid something like £200 for a course of laser treatments. It did not work, they even gave her extra treatments, still no improvement. She had given up complaining to the "doctor" who assured her that it would work.

I've had patients who tell me they have also had oral terbinafine and was assured "it would work". I have had patients tell me they have had orthotics and were assured "it would work" and they didnt. I have had patients who had antibiotics for a sore throat and they also didnt work.

Heck my mechanic told me replacing my exhaust manifold would stop my car making the dreadful noise it does - that also didnt work.....

Whats your point?

We all simply do the best we can for our patients. Sometimes things dont always work. Nothing medical has a 100% certainty attached to it.

[quote=Paul Bowles;286117]I've had patients who tell me they have also had oral terbinafine and was assured "it would work". I have had patients tell me they have had orthotics and were assured "it would work" and they didnt. I have had patients who had antibiotics for a sore throat and they also didnt work.

Whats your point?

My point is that I have very little faith in lasers working for Onychomycosis. Maybe the person I was taking about did not have fungal nail infection. As for a sore throat antibiotics would only work if the infection was bacterial and not viral.

[quote=zsuzsanna;286227] You base you opinion on "faith" and N=1? I notice you didnt attempt to address the orthotics one or my car issue for that fact (which in case you missed the sarcasm) were all in fact hypotheticals to prove the point that nothing has a 100% certaintly.

You are denying your patients options because "you have very little faith" and "maybe the person you were talking about didn't have OM" - seriously?

Might be worth reading the literature a little, being open to options and understanding the evidence before formulating your N=1 clinical opinion - your patients will appreciate it.

[quote=Paul Bowles;286285] Hi Paul

I am more charitable to what seems to being said here. There is lack of any serious evidence of efficacy for use of "laser" treatment for onychomycosis.

What is apparent is overly optimistic "marketing" by podiatrists and others lauding the hight tech benefits of laser.

As you state; those being offered treatment should, when possible, be informed of what is known regarding their of outcome probability. Currently, unless we look at emprical evidence of individual practitioners (n=1), this is lacking and this should be made clear. We are looking at considerable issue of cost benefit ratios here. Same I feel needs to applied to use of penlac which was marketed on basis of marketing information which did not make explicit the measured endpoint was clincal improvement not cure.

Cheers

Martin

Foot and Ankle Clinic
1365 Grant Ave.
Winnipeg Manitoba R3M 1Z8
phone [204] 837 FOOT (3668)
fax [204] 774 9918
www.winnipegfootclinic.com

[quote=Mart;286289] I don't disagree - but the same could be said for other services provided by Podiatrists could it not? Certain so called "sports Podiatrists" (especially in Australia) who push plastic like its bottled water? Just stating the obvious, yet that aspect never gets crucified.

There is evidence out there - its better than N=1 as well. The fact is most dismiss it based on the above point. Is the evidence for custom orthoses vs off the shelf orthoses that much better? But again why don't we see this crucified? My previous point was merely demonstrating the demonsterable fact that regardless of the lack or plethora of evidence, some people will only believe dogmatic approach. Its blatantly obvious that some people are hell bent on criticising any treatment they do not provide, but they have never even used.

Not familiar with Penlac in Australia apologies.

[quote=Paul Bowles;286313] [quote=Paul Bowles;286313] I agree regarding overuse of foot orthoses; this is a more complex issue though because its underpinning need is likely multifactorial and I believe necessarily very empirical. Again my emphasis is that patient needs to understand why this and if possible probability of outcome even if this is based on clinicians experience since this may be best available evidence.

Penlac is terbinifine laquer which in Canada runs at about $110 per tiny bottle. I have yet to see a cure and stopped using it after reading the benchmark study which was ironically the study used to market the product here.

Cheers

Martin



Foot and Ankle Clinic
1365 Grant Ave.
Winnipeg Manitoba R3M 1Z8
phone [204] 837 FOOT (3668)
fax [204] 774 9918
www.winnipegfootclinic.com

[quote=Mart;286316][quote=Paul Bowles;286313]

Has more relationship to orthoses for the very reason you state above.... I think we are on a similr page. Thanks for the penlac info.

There is a need for further research on the efficacy of laser treatment for toenail fungus. A couple of these treatments, as far as I know, has been cleared by the FDA to be used specifically for toenail fungus and the rest are for "off-label" use.

FDA seems more concerned with evidence of safety than efficacy for this; within the marketing of "laser tx" for onychomycosis the FDA approval is sometimes used to imply efficacy - this seems either disingenuous or ignorant.

thats my rant for the day

Cheers

Martin

Foot and Ankle Clinic
1365 Grant Ave.
Winnipeg Manitoba R3M 1Z8
phone [204] 837 FOOT (3668)
fax [204] 774 9918
www.winnipegfootclinic.com

That is my gripe from earlier in this thread. All the FDA have done is clear it as being safe. Those touting this approach have used this FDA clearance on safety in their marketing to imply that the FDA said that it is efficacious, when that is NOT what the FDA ruled.

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Ok - so I have an interesting excercise - as people know we have been collecting data on the 1064nm laser for almost 6 months now. We have patients who have had no intervention, oral terbinafine and laser 1064nm. I will randomly grab one case, and select an initial photo and then a photo from a 3 month follow up. I will get the initial case notes and post them but wont look at which intervention group they were allocated too. Lets have some discussion based on any changes and people can give us their clinical thoughts on the possible changes or lack there of and why that may be (positive or negative) and how they would have managed this case. It think it will be an interesting excercise - anyone want to play? Should be fun none the less!!!

Then we can reveal what treatment group they were allocated to and what gthe treatment was (time, dose, null).

Sounds like fun to me

Cheers

Martin

Me, me! Can I play, even if I`m a girl?

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Pt AX2013-B

History: right hallux longitudinal discoloration present for 7+ years. Stated that they thinks it is getting worse slowly. No infection on any other digits however wife also has the same problem and she wants to seek treatment as well.

Medical History: Overweight male 56 years old. Generally well, no reported medical history of note.

Medications: Currently none. Has previously tried topical tea tree oil with no success as well as topical Loceryl 5% for 12+ months applied twice weekly with no real success. History of nail sample for pathology from general practitioner shows positive onycomycoses.

Treatment: Patient AX2013-B - nail cut and shortened on initial visit, podospray drill with tungston tip burr used to lower nail height. Pt AX2013-B allocated to treatment group (could have been no treatment, oral terbinafine group or 1064nm laser group).



Picture A: Pre allocation to group

The patient was reviewed at 12 weeks and the nail was again shortened and ground down using a tungston burr



Picture B: Post 3 months

So - lets see:

Regardless of the treatment - do you think at 3 months the appearance is conducive to a good result for the patient?

What treatment do you believe this patient might have had?

Personally I do not know what treatment group they were allocated to - I can check though by matching the patient code to our database and then calling the patients electronic file.

Lets have a civil discussion and try and get somewhere with this....

Blinda you are the resident and foremost expert on fungus here at the Arena - I would be upset if you didn't play and the community would also be at a loss!!!

I`m no expert, really I`m not. Just nerdy about skin

OK, definately improved clinical outcome, as overall fungal load is reduced and the active part no longer appears to be in the matrix.

Impossible to say which tx they had, so I`ll made a wild stab in the dark.....laser?

Good game, good game.

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Agreed good result so far but my money on oral terbinifine. If this is laser result that would be particularly impressive (and I will eat my santa suit) because, as Blinda mentioned, infection did appear to extend into proximal nail fold which would imply same of laser effect.

Cheers. Martin

Foot and Ankle Clinic
1365 Grant Ave.
Winnipeg Manitoba R3M 1Z8
phone [204] 837 FOOT (3668)
fax [204] 774 9918
www.winnipegfootclinic.com