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Laser eye surgery has enabled millions of people to throw away their eyeglasses. Now several medical technology companies are hoping that lasers aimed at the feet will allow millions to take their socks off, even in public.
The target is toenail fungus — an infection in an estimated 10 percent of American adults, or 23 million people — that causes toenails to become thick, yellow and fetid.
If these lasers, which recently completed small clinical trials, work, they will represent a new way to treat nail infection by selectively irradiating fungi while leaving the nail and surrounding tissue intact.
Right now, there is no sure cure. The fungi are so hardy that popular antifungal pills, which carry a small risk of liver damage, are completely successful less than half of the time. And a prescription lacquer, painted on the toenails daily for 48 weeks, has a complete cure rate of less than 10 percent.
Pharmaceutical giants like Schering-Plough and Novartis are developing new lacquers, pills and ointments to battle the fungi. But some podiatrists and patients are pinning their hopes on the experimental laser treatments.
Nomir Medical Technologies in Waltham, Mass., is developing a laser called Noveon for diseases like antibiotic-resistant staph infections as well as nail afflictions.
Noveon is a type of laser already commonly used by doctors for treatments like cataract surgery, dental work and even hair removal. Noveon beams two different wavelengths of near-infrared light at toenails to selectively take aim at and kill fungi.
After four treatments with Noveon, about half of the 39 toenails tested no longer had active nail infections, according to the results of a clinical trial that the company presented this month at a national dermatology meeting. Six months after the initial treatment, about 76 percent of the volunteers had clear nail growth, the study reported.
“We will be able to reach people who have heretofore stayed away from treatment because of the toxicity or the costs or other reasons,” said Richard F. Burtt, Nomir’s chief executive.
Mr. Burtt said the company was preparing to submit the data to the Food and Drug Administration, hoping to receive clearance to market Noveon by this fall. The agency has already cleared Noveon for use on the skin and in nasal passages. But the company is not taking orders for or distributing the laser for nails until it receives specific permission to do so, Mr. Burtt said.
Another company developing a laser, PathoLase, is so eager to get a piece of the billion-dollar-plus market for antifungal nail treatments that it has not waited for federal permission to begin marketing its device, the PinPointe Footlaser, for use on toenail fungus. Nearly 70 podiatrists in 21 states already offer PinPointe, according to PathoLase. The treatment, which is not covered by health insurance, costs $1,000 or more.
The F.D.A. requires manufacturers to wait for federal clearance before marketing a medical device for specific uses. But PathoLase appears to have jumped the gun in the war on spores.
Last week, a news broadcast by a Fox affiliate in Manhattan featured PinPointe as the latest thing for nail disorders. Dr. Stuart J. Mogul, a podiatrist in Manhattan who demonstrated the laser during the broadcast, said he had recently treated four patients with PinPointe at a cost of $1,200 each. He said it was too soon to tell whether the treatment had worked.
“I explain to patients that the only risk is financial,” Dr. Mogul said in an interview last week.
He added that representatives of PathoLase had told him that the F.D.A. had approved the laser as being safe.
Up until Tuesday, PinPointe’s Web site promoted the toenail laser as “F.D.A. cleared” and included an endorsement from a podiatrist in California saying he had used the device for six months on 225 patients.
Because the F.D.A. cleared the device in 2001 for use in dentistry, doctors are free to use it for other purposes, John Strisower, the chief executive of PathoLase, said in an interview on Monday.
Technically, the F.D.A. does not regulate the practice of medicine, so doctors are indeed able to use approved drugs and devices for unapproved purposes when they deem it appropriate.
But Timothy A. Ulatowski, director of compliance at the Center for Devices and Radiological Health at the F.D.A., said companies were legally allowed to market a medical device only for the specific use for which it had been granted clearance. Selling or promoting a device for unapproved indications is illegal, he said. He added that the company might face action from the agency, ranging from a warning letter to fines, injunctions or product seizures.....
new? I've been using laser Tx on fungal nails since the early 1980's. Good results, largely dependent on the patients compliance with applying the med BID. ciclopirox olamine solution seems to be a bit more effective than previous meds.
Usually fungal nails are due to a weakness in the toenail caused by Trauma. the most common trauma is tight shoes. That's why most women develop fungal or damaged nails on their 1st and especially 5th toenails. This damage is permanent and no medication or laser can reverse matrix cells that have been killed by ischemia caused by tight shoes. The fungus can be cured with lamasil but the damaged nails will still show this damage be more porous and prone to fungus. Seldom does fungus spread from a damaged nail to an adjacent normal nail so the fear of fungus on locker room floors is silly. Fungus is everywhere in our environment. In nail salons frequently the "technicians" (using sterile equipment) push back cuticles opening them up allowing a perfect bed for yeast infections. Again this is not due to dirty equipment but opening up the cuticle. The cuticle is a seal between the skin and the nail and should not be opened.
Lets all get real when it comes to fungus how many patients have you seen with one or two fungal nails and never had seen it spread for ten or twenty years to adjacent nails. You know it is not contagious. You know the true reason for nail fungus.
The Following User Says Thank You to facfsfapwca For This Useful Post:
Usually fungal nails are due to a weakness in the toenail caused by Trauma. the most common trauma is tight shoes. That's why most women develop fungal or damaged nails on their 1st and especially 5th toenails.
Yep, agree with that. Trauma (tight fitting shoes) plus occlusive footwear is a safe harbour for dermatopyhtes, which is why we witness a rise in incidence during winter months in particular.
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This damage is permanent and no medication or laser can reverse matrix cells that have been killed by ischemia caused by tight shoes.
This is a point that many practitioners fail to appreciate; slow tissue growth and poor blood flow mean that onychomycosis is difficult to target. However, the damage is only permanent if the entire matrix has been damaged as healthy nail regrowth is possible if external conditions, which lead to initial infection, are suitably corrected, along with appropriate fungicidal medication.
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Seldom does fungus spread from a damaged nail to an adjacent normal nail so the fear of fungus on locker room floors is silly. Fungus is everywhere in our environment.
Whilst transferral of infection from nail to nail is unlikely, we cannot ignore the important interplay between skin and nail infection. It is well documented that onychomycosis commonly leads to tinea pedis and vice versa (particularly where the nail plate has been subject to trauma). Therefore, the skin can act as a reservoir for pathogenic fungi, so I wouldn`t necessarily declare locker room infection as silly. As facfsfapwca (Please give us an easier pseudonym!?) stated “fungus IS everywhere in our environment” and infection spreading from one site of the body to another is possible, even probable amongst those with a history of relapses and reinfections, that is patients with defective cell mediated immunity that prevents them from mounting an effective host response are predisposed to chronic infection, spread of infection and recurrence.
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In nail salons frequently the "technicians" (using sterile equipment) push back cuticles opening them up allowing a perfect bed for yeast infections. Again this is not due to dirty equipment but opening up the cuticle. The cuticle is a seal between the skin and the nail and should not be opened.
Absolutely, the eponychium is often compromised when the cuticle is pushed back in pedicures, leaving a portal of entry for all kinds of opportunistic visitors!
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Lets all get real when it comes to fungus how many patients have you seen with one or two fungal nails and never had seen it spread for ten or twenty years to adjacent nails. You know it is not contagious. You know the true reason for nail fungus.
I agree that fungal infection is not contagious to a proportion of the population (ie those who do posses cell mediated immunity) and, whilst this is straying from the theme of this particular thread, I would greatly appreciate your expansion on what you consider to be the true reason for onychomycosis?
Usually fungal nails are due to a weakness in the toenail caused by Trauma. the most common trauma is tight shoes. That's why most women develop fungal or damaged nails on their 1st and especially 5th toenails. This damage is permanent and no medication or laser can reverse matrix cells that have been killed by ischemia caused by tight shoes. The fungus can be cured with lamasil but the damaged nails will still show this damage be more porous and prone to fungus. Seldom does fungus spread from a damaged nail to an adjacent normal nail so the fear of fungus on locker room floors is silly. Fungus is everywhere in our environment. In nail salons frequently the "technicians" (using sterile equipment) push back cuticles opening them up allowing a perfect bed for yeast infections. Again this is not due to dirty equipment but opening up the cuticle. The cuticle is a seal between the skin and the nail and should not be opened.
Lets all get real when it comes to fungus how many patients have you seen with one or two fungal nails and never had seen it spread for ten or twenty years to adjacent nails. You know it is not contagious. You know the true reason for nail fungus.
Then; what would you say to these photos? If I may be able to attach them:))
Mmmm I could not. I may send it to your mail if you want. One of my patients. She had 2 fingers in each hand and feet with fungus, but spreaded to all during pregnancy. And I cannot treat it:(((
Usually fungal nails are due to a weakness in the toenail caused by Trauma. the most common trauma is tight shoes. That's why most women develop fungal or damaged nails on their 1st and especially 5th toenails. This damage is permanent and no medication or laser can reverse matrix cells that have been killed by ischemia caused by tight shoes. The fungus can be cured with lamasil but the damaged nails will still show this damage be more porous and prone to fungus. Seldom does fungus spread from a damaged nail to an adjacent normal nail so the fear of fungus on locker room floors is silly. Fungus is everywhere in our environment. In nail salons frequently the "technicians" (using sterile equipment) push back cuticles opening them up allowing a perfect bed for yeast infections. Again this is not due to dirty equipment but opening up the cuticle. The cuticle is a seal between the skin and the nail and should not be opened.
Lets all get real when it comes to fungus how many patients have you seen with one or two fungal nails and never had seen it spread for ten or twenty years to adjacent nails. You know it is not contagious. You know the true reason for nail fungus.
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.
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.
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Originally Posted by Tess Bowen
I file them down if they are thick,apply something to waterproof the nail and use lavenda oil..
Can you expand on your clinical reasoning for this regime?
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.
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.
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Originally Posted by Tess Bowen
I started using Lavendar oil when I found out it had fungastatic properties comparable to most other topical treatments on the market.
Did this piece of research state HOW it compared to other topical anti-fungals, with regard to efficacy and safety?
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Originally Posted by Tess Bowen
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.
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;
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Originally Posted by Tess Bowen
I know there are some warnings around the use of Lavendar oil during pregnancy and with young boys.
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.
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Originally Posted by Tess Bowen
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
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?
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Originally Posted by Tess Bowen
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.
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;
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.
Compromised individuals HIV even Downs syndrome are predisposed to fungal infections.
nails that have permanently weakened can be improved with lamasil PO but the weakness is still there and will recur in a year or two. Clean or dirty locker rooms won't change this except for HIV or other immunde compromised..
Why do people give the attribute of curing nail fungus with products not indicated for nails? If a topical worked on nail fungus it would be to their advantage to state so in their literature and indications. The only topical so far is Penlac and its cure rate is low.
Putting plane baby oil (not even tea tree oil) on a nail and debriding it will make it look better. Stating that Baby oil is a cure would seem foolish. So is stating that Teatree oil is just as foolish.
What is the mechanism for Laser's to cure fungus. Does it bring to life the dead matrix cells? Ha Ha
Absolutely agree that pts with systemic conditions such as Downs, Parkinsons, DM, etc and those with compromised immunity are predisposed to OM (hence my reference to `patients with defective cell mediated immunity….`) and that recurrence is likely where the nail has been weakened by disturbed matrix function. Yes, the weakness will always be there, but as these individuals are susceptible to spread of infection, I would advise those with suppressed immunity to take reasonable precautions in communal bathing facilities, etc where evidence has shown that tinea infection is possible and compromises the integrity of the skin and may result in secondary bacterial infections.
I`m not disagreeing with you here, of course any cells that suffer ischaemia/death will not synthesize trichocytes and as the nail bed cornifies the nail grooves lose their normal contour/become porous. I`m sorry I did not make myself clear, I merely meant that any matrix cells that had NOT been damaged are capable of producing a healthier (that is healthier than a fungal infected) nail if external conditions, such as footwear are addressed along with medication, etc, etc.
Anyway, anyway, anyway we`ve gone off topic here and like you, I would be interested to know;
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What is the mechanism for Laser's to cure fungus. Does it bring to life the dead matrix cells? Ha Ha
Does it have resurrective (not sure that`s a word?) qualities? I`m sure if it is at best as effective as Penlac or Amorolfine, the evidence woul dhave been published. Does anyone know of any up to date research on laser tx for OM?
I am quoting you and correcting you. "the damage is only permanent if the entire matrix has been damaged as healthy nail regrowth is possible if external conditions, which lead to initial infection"
Nail matrix is a group of cells and when some of them have been killed by ischemia from a tight shoe. They are i repeat "killed". You will always have a line or porous area where the matrix has been "killed". "healthy regrowth" is NOT possible. The nail may regrow free of fungus if treated with PO Lamasil but will always by missing those dead cells and recurrence is always likely depending on the extent of the damage. Even Lamasil has a diagram of a "cured Nail" they show lines and discoloration it is not normal. Why do people say a nail will regrow normally if cells have been killed?
Laser nor anything else can bring dead cells to life. Before i would try a laser I would like a detailed explanation of why it should work and double blind studies (the surgeon doesn't know whether the laser is on or not. I can tear off a fungal nail clean the nail bed there will be no fungus and the new nail will eventually be the same if not worse than the old one. Why would burning the nail change the fact that matrix cells are missing?
Does it have resurrective (not sure that`s a word?) qualities?
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Laser nor anything else can bring dead cells to life
Unfortunately wit is often lost in forum speak, I was trying to be ironic
I`m in agreement, once the matrix is damaged i fail to see how laser tx will acclomplish anything superior to what is currently advocated in the Cochrane.
Systematic reviews of evidence. Taken from the website;
"The Cochrane Library is a collection of databases that contain high-quality, independent evidence to inform healthcare decision-making. Cochrane reviews represent the highest level of evidence on which to base clinical treatment decisions."
I checked on line and searched Cochrane library using Onychomycosis and toenail found no reference to either. It would be great to find evidence based medicine on this topic.
Press Release: PinPointe™ FootLaser™ Submits Its Breakthrough Laser Treatment For Toenail Fungus To Health Canada For Approval 22 Jul 2009
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PinPointe FootLaser announced it has submitted its innovative new laser treatment for toenail fungus (Onychomycosis) to Health Canada for approval. As the Federal department responsible for helping Canadians maintain and improve their health, Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada. PinPointe FootLaser has been awarded the CE Mark certifying it has met European Union consumer health and safety standards, has been cleared for use in the treatment of toenail fungus in the EU, and can be offered by healthcare providers throughout Europe. Additionally, the treatment is FDA cleared for applications in dermatology, plastic surgery, and podiatry in the United States.
John Strisower, CEO of PathoLase, noted that he is confident the device will be made available to licensed Canadian medical practitioners after the Health Canada review process is completed. Stated Strisower: "Onychomycosis afflicts approximately 900 million people around the world, including millions in Canada. We're very much looking forward to making PinPointe FootLaser available to Canadian practitioners as well, offering them an excellent opportunity for providing a unique and valuable service to their patients."
Safe Quick Treatment - No Drugs, Pain or Anesthesia
Introduced in 2008, PinPointe FootLaser uses a patented laser technology to target the pathogens that cause toenail fungus. With PinPointe FootLaser, patients are treated safely and quickly with no drugs, no anesthesia and no pain. PinPointe's laser light passes through the toenail without causing damage to the nail or surrounding skin. Following the procedure, the new nail will grow in healthy and clear. Unlike medication-driven treatments for toenail fungus, PinPointe FootLaser presents minimal risk of side effects. Competing medication procedures can result in a wide variety of side effects, including liver toxicity.
New Clinical Trial Currently Underway
Following an early study conducted among a small group of patients (Harris, McDowell and Strisower, Laser Treatment for Toenail Fungus, Proc. SPIE 7161A, 2009), which indicated a potential efficacy rate as high as 87%, the treatment is currently undergoing a major multi-site clinical trial entitled "Multi-Center Trial: Evaluation of PinPointe FootLaser Treatment for Infected Toenails (Onychomycosis)". The study, which has been granted approval by Health Canada, is being conducted at the dermatology clinic and research facility of Aditya K. Gupta, M.D., Ph.D., M.A. (Cantab), DABD, FAAD, FRCPC in London, Ontario, as well as at three additional sites in the U.S.
Press Release: "Following the procedure, the new nail will grow in healthy and clear."
We'll see about that claim and how true it is and for long it lasts, if it ever occurs in many patients. My advice.....?......don't hold your breath.
__________________
Sincerely,
Kevin
**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College
Press Release: PinPointe™ FootLaser™ Submits Its Breakthrough Laser Treatment For Toenail Fungus To Health Canada For Approval 22 Jul 2009
Then put out a press release claiming how good it is.
...don't figure!
How often have we seen this pattern? (eg ESWT; MIS; etc)
__________________ Craig Payne
__________________________________________________ ___________________________________ Follow me on Twitter | Run Junkie God put me on this earth to accomplish a certain number of things - right now I am so far behind, I will never die.
The pinpoint laser—cleared by the FDA in 2008 to treat toenail fungus.
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“The success rate is proven to be 88 per cent, again there is a chance of recurrence if you don’t follow hygiene,“ Dr. Weinstein said.
According to the NY Times, the FDA have not cleared the PinPointe Laser for toenail fungus and according to PinPointe's own press release above, the proven succes rate:
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Following an early study conducted among a small group of patients (Harris, McDowell and Strisower, Laser Treatment for Toenail Fungus, Proc. SPIE 7161A, 2009), which indicated a potential efficacy rate as high as 87%, the treatment is currently undergoing a major multi-site clinical trial
What I can't figure out, is that this new laser machine is "new". The claims are that it takes up to a year before the nail fully grows out before the effect is seen after the one treatment that is claimed that is needed. If that is the case, then none of the people above have been using it for a year or more .... if that is the case where are all the testimonials for it coming from? How do they actually know it works that well? ... don't figure? Should this be in the snake oil category?
__________________ Craig Payne
__________________________________________________ ___________________________________ Follow me on Twitter | Run Junkie God put me on this earth to accomplish a certain number of things - right now I am so far behind, I will never die.
Laser treatment for nail fungus
(recovering reveller) toeslayer
Re: Laser treatment for nail fungus
Re: Laser treatment for nail fungus
Does it have resurrective (not sure that`s a word?) qualities? I`m sure if it is at best as effective as Penlac or Amorolfine, the evidence woul dhave been published. Does anyone know of any up to date research on laser tx for OM?
Hybrid Mode
