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Treatment of Onychomycosis With Long Pulsed Nd:YAG Laser
Rungsima Wantiphakedeedecha
study linked above:
Patients received four laser treatments at one week intervals.
The percentage of positive fungal culture tended to decline in the following visits as there were 85%, 56%, and 44% of positive fungal culture at the 2nd, 3rd, and 4th weeks, respectively.
Treatment of Onychomycosis With Long Pulsed Nd:YAG Laser
Rungsima Wantiphakedeedecha
study linked above:
Patients received four laser treatments at one week intervals.
The percentage of positive fungal culture tended to decline in the following visits as there were 85%, 56%, and 44% of positive fungal culture at the 2nd, 3rd, and 4th weeks, respectively.
Its all pretty meaningless given the lack of any sort of control group.
If you put a laser to work in your practice and within a month over 50% of the patients no longer had positive cultures would it be 'meaningless' to you or them?
The Mercury News are reporting: Spa owner accused of practicing medicine without a license
Quote:
A San Jose spa owner who owns several Shiny Toes shops in the Bay Area is facing felony charges after investigators seized evidence from his office and charged him with injuring a 4-year-old child during laser treatment.
Cary Silberman, 52, was arrested Monday by investigators from the Medical Board of California and was charged by the Santa Clara County District Attorney's Office with two felonies, including practicing medicine without a license and grand theft by fraud, and one misdemeanor count of child endangerment.
This was Silberman's second alleged offense. Last month, Silberman pleaded no contest to practicing law without a license.
Silberman called the criminal case brought by the medical board "a travesty" that was sparked by an angry San Francisco podiatrist who is jealous over his success.
To All,
How do you treat a control group? The lights go on but nothing happens (All the "Bells and Whistles" but no "Bang for their Buck")!
It is all well and good for the uni based Pods to be critical but where is their evidence that the machines don't work.
They site "Cochrane" and others but how can you believe these results what check and balances do they go through?
If a company give a machine to a study group to do a double blind and they use machine outside the parameter specified by that company then are not the result negated?
To All,
How do you treat a control group? The lights go on but nothing happens (All the "Bells and Whistles" but no "Bang for their Buck")!
It is all well and good for the uni based Pods to be critical but where is their evidence that the machines don't work.
They site "Cochrane" and others but how can you believe these results what check and balances do they go through?
If a company give a machine to a study group to do a double blind and they use machine outside the parameter specified by that company then are not the result negated?
Don Scott
Don, I have offered previously and have never been taken up on the offer of doing a double blinded randomized controlled trial with one of these lasers. Seriously it wouldn't actually be that hard considering the lasers emit no determinable effects other than light (and that can be accounted for in a trial).
Same way double blind randomized controlled trials have been done with Ultrasound.
Don I most definitely am not saying the machines "don't work", i've seen patients who have had it done and I make my patients aware it exists. However I still would like to see a few DB-RCT using it without company funding. Even if its for s*its and giggles sake.
My offer still stands if pin pointe or cutera or any of the others want to take it up....no bias, just the facts.
The Following User Says Thank You to Paul Bowles For This Useful Post:
all this scientific talk of lasers and solutions when the number 1 most effective treatment is oral terbinafine. costs involved wales free england cost of a prescription about 7 quid so why would anybody have a 700 quid laser treatment as their initial therapy not very ethical to push patients down this route imho
__________________
drive it like you stole it
The Following User Says Thank You to fishpod For This Useful Post:
Do you have any idea of the possible complications, intolerance, of oral terbinafine? Do you want to take responsibility for prescribing it? Do you want to order monthly liver studies? All for a 50% success rate?
Frederick where does this 50% figure come from? Reference would be appreciated.
In my experience I have been using oral terbinafine in patients for years monitoring them closely and informing them of all possible issues. I can honestly say in over 10 years I have never had a complication arising from oral terbinafine seen in any patient - besides one who stated she had nightmares and another who temporarily lost some of their taste. Both stopped the drug and the issues resolved.
I can also say that clinically it appears to have a much higher success rate than 50%.
A couple years ago some very preliminary studies made us think that there might be a chance that lasers had some potential to treat fungal nails. As time goes on, however, we are disappointed to see that there is simply no credible evidence that lasers provide any significant treatment capability for treating onychomycosis (fungal toenails). Most of the advertising we see for this treatment makes us look at it more and more as a scam.
So, our recommendations still stand – we are advising our patients to avoid paying any money for treatment of nail fungus with any laser.
Press Release: NuvoLase Inc. Acquires All Assets and Rights to the PinPointe FootLaser™
Quote:
NuvoLase Inc., a Delaware corporation, announced today it has acquired from PinPointe USA all rights, assets and intellectual properties associated with the PinPointe FootLaser. Pursuant to its agreement with PinPointe USA, NuvoLase also gains access to all current and future product development activities.
PinPointe FootLaser, the first light-based device to receive FDA clearance specific to the treatment of Onychomycosis (nail fungus), is recognized by industry leaders as the gold standard product and alternative treatment for those patients suffering from Onychomycosis. With almost 100,000 treatments performed worldwide with the PinPointe FootLaser thus far, the FootLaser is the only device on the market today with documented clinically proven efficacy for the treatment of nail fungus. As part of the transaction NuvoLase also has access to all the regulatory clearances for the FootLaser, including the FDA clearances, CE Mark, TGA and Health Canada.
NuvoLase Inc. also announced today that it has selected a seasoned veteran with significant medical, laser and industry experience to take this business opportunity to new levels. Effective immediately, Mr. Steven P. Duddy has been appointed President and CEO of NuvoLase and will also serve as member of the company’s Board of Directors.
Mr. Duddy commented, “I am both pleased and excited about the opportunity. The PinPointe FootLaser continues to be the product/treatment of choice for those looking for an alternative to risky oral medications.” He added, “Short term, NuvoLase will be focused on expanding market share, both domestically and abroad, and increasing revenue through focused distribution and marketing activities. Longer term, we will utilize the existing technology and intellectual properties as a spring board to grow our product portfolio, thus increasing our overall value to customers, employees, shareholders and investors.”
It appears that lazer treatment for fungus toenails can be an affective method to kill fungal organisms throughout the nail tissue and the underlying nail bed. Like anyother treatment, the new nail has to grow out until the nail appears normal. The appearance of a normal nail and recurrence is dependent on the nails ability to resist becoming infected with fungus again. From my experience, abnormal nail tissue that reaches the matrix, have a lesser chance to grow normal in appearance and become reinfected.
I have noticed that some of the big clinics over here (Queensland, Australia) seem to be splashing their cash on the pinpointe lasers. Interesting.
Maybe I should get one before all the mycotic nails get cured? There will be none left for me!
In Spain we have recently known about this therapy. I think that it´s gonna be a revolution into the field of podatry. Prospective studies are going to be taken, let see what happen (the economy situation is not so good as we want)
All my admiration and respect for the American podiatry.
Regards from Spain and sorry for my english
Somewhere in this thread there was some confusion between Pinpointe Foot laser and Pinpoint Laser Systems. I have been contacted by the company about this and they did not point out exactly where the confusion was and I can't be bothered searching through 12 pages for it. Here is there email FYI:
Quote:
To Whom it May Concern:
I came across your website today.
Please be advised that you have the wrong company name listed on your website. Pinpointe Foot Laser (Please note the spelling) is the name of the company that you are referring to. We are Pinpoint Laser Systems and we are not affiliated with Pinpointe Foot Laser. Using our name is a trademark violation; therefore, we would appreciate it if you could correct the spelling.
The PinPointe™ Footlaser™, CoolTouch TRIO Breeze™ and the GenesisPlus™ are infrared lasers designed to treat onychomycosis (fungal nail infection). The laser beam is passed through the nail and surrounding tissue with the aim of destroying the fungal organisms causing the infection. If proven to be effective these lasers may offer a faster method of treating onychomycosis with fewer side effects than drug therapy.
If PinPointe really does have the peer-reviewed research (and which was not funded by PinPointe) to refute my claims, then let them present it here on Podiatry Arena and I will happily retract my statements. If they want equal billing, have them bring their head researcher on here to tell us how good PinPointe really is in curing toenail fungus.
I've not been able to find the treatment parameters used in the PinPointe FootLaser data.
Has anyone here seen this data?
What were the pulse width, fluence, spot size and number of pulses? Was debridement done?
Can someone post a link to an article? The FDA approval doc linked earlier in this thread mentions nothing about the treatment protocol used.
Basheer Badiei, MD
I don't think this is the clinical trial as that seems to be impossible to dig up but here is a link with a protocol, I think each pulse is 25.5 j/cmsq and they estimate giving off about 10-20 pulses per square cm
"The study design included the enrollment and inclusion of retrospective data from all subjects (up to 150 subject-toes) meeting pre-defined inclusion/exclusion criteria to evaluate the safety and effectiveness of treatment following one treatment session (80-[micro]sec pulsed laser with a per-spot fluence of 25.5 J/[cm.sup.2]) delivering a total surface irradiance of 255 J/[cm.sup.2] (one-pass) or 510 J/[cm.sup.2] (two-pass) for the treatment of infected toenail (onychomycosis). "http://findarticles.com/p/articles/mi_m0PDG/is_9_9/ai_n55286215/pg_3/
This source is not entirely invalid, but readers should know that it is a journal owned by Fotona, only publishing stories about Fotona products, to advance Fotona marketing. One of the two sources cited is the same journal article that Fotona regularly uses to espouse near 100% success.
This source is not entirely invalid, but readers should know that it is a journal owned by Fotona, only publishing stories about Fotona products, to advance Fotona marketing. One of the two sources cited is the same journal article that Fotona regularly uses to espouse near 100% success.
Colleagues:
This is a very good point.
Certainly when this level of evidence is compared to the 8 peer-reviewed and independent publications for the Noveon Laser System, published over the last three years, such as can be seen below.
1) Bornstein E and Gridley S., Antifungal synergy produced in Candida albicans with 870nm/930nm near infrared photodamage, 9th International Mycological Congress, Future strategies for the control of fungal diseases, Edinburgh Uk. Aug 1-6 2010
2) Landsman A, Robbins A, Angelini F, Wu C, Cook J, Bornstein E. Treatment of mild, moderate and severe onychomycosis using 870nm and 930nm light exposure. JAPMA 2010; 100(3):166-177.
3) Bornstein E., S. Gridley, and P. Wegender (2010) Photodamage to Multidrug-resistant Gram-positive and Gram-negative Bacteria by 870 nm/930 nm Light Potentiates Erythromycin, Tetracycline and Ciprofloxacin. Photochem. and Photobiol , Volume 86, Issue 3, pages 617–627, May/June 2010
4) Bornstein ES. A Review of current research in light-based technologies for treatment of podiatric infectious disease states. JAPMA 2009; 99 (4):348-352.
5) Bornstein E, Hermans W, Gridley S, and Manni J. Near infrared photo-inactivation of bacteria and fungi at physiologic temperatures. Photochem Photobiol 2009; 85(6):1364–1374
6) Bornstein ES. Treatment of onychomycosis using the Noveon® dual-wavelength laser. FDA Pivotal Study data presented at Council for Nail Disorders 13th Annual Meeting, San Francisco, CA, March 5, 2009.
7) Bornstein ES, Robbins AH, Michelon M. Photo-inactivation of fungal pathogens that cause onychomycosis in vitro and in vivo with the Noveon dual wavelength laser system. In Proceedings of the 9th Annual New Cardiovascular Horizons, p.72, New Orleans, LA, September 10–13, 2008. New Cardiovascular Horizons, Lafayette, LA.
8) Bornstein, E.S., Y.P. Krespi, A. Robbins, J. Wlassich, E. Sinofsky (2008) Antimicrobial resistance reversal at physiologic temperatures in MRSA in the nares with an 870 nm and 930 nm dual wavelength noveon laser. 2008 Tissue Engineering and Regenerative Medicine International Society North America Meeting Abstracts.
My Take:
There are a lot of podiatrists out there that WANT this to work. They can bill a good amount for their time, most of it cash, and fill a void in their practice that insurance companies have created by decreasing payments for other services.
I do not perform this service, but we are certainly not the only specialty looking for other revenue options. Look at all the aesthetic clinics opening, spider vein treatments, fascial resurfacing, hair replacements, cosmetic surgery, botox injections, medical spas, weight loss products, energy supplements, anti-aging treatments, alternative medicine......
Sad to say, this is what it's all coming to. I hate to see what medicine is going to look like in 25 years.
"Need a cardiac bypass, sorry, you're too old, but I can inject a bit of collagen around your nose for $750 and make you look better"
Steve
__________________
DrSArbes
Fellow American College of Foot & Ankle Surgeons
Board Certified Foot & Ankle Surgery, ABPS
Adjunct Professor OCPM
Green Bay, Wisconsin, USA
The purpose of this clinical study is to improve the appearance of onychomycosis and morphology of the nail (fungal infection). The researcher can use a light based therapy to gently heat the toenail infected with fungus to improve the appearance of onychomycosis.
The study aims to investigate the effectiveness of a single application of Erb:YAG laser to the nail plate in increasing the efficacy of the amorolfine lacquer used in the treatment of onychomycosis (fungal infection of nails) cause by dermatophyte molds. This clinical trial respective involve 30 subjects with hands or feet distal-lateral subungual onychomycosis (a kind of onychomycosis that does not affect the ungual matrix). The patients will receive treatment for 6 months meanwhile they will be followed up to access efficacy of the treatment by means of the clearance of nail plate infection.
This thread seems to never end. I have practiced podiatry in the USA for 30 years. I have treated fungally infected toenails with many methods. I have never found any medications to penetrate the nail tissue and extend to the nail bed even though Dr. Kirby has sited a study. I have added povodone scrub to a regimen of topical treatment which help improve results. But frankly, we are dealing with an infection that starts distally and progresses proximally to the nail matrix. Regardless of the treatment used, if the nail matrix has been infected it will usually produce abnormal nail tissue that has lost its resistance to fungal organisms and the recurrence rate increases. If this is the case, then treatment of the fungal infection is a management issue and will not be cured. Regarding one of the posts that implied combining other treatment with laser therapy skews the understanding if laser therapy alone resolves the infection may be correct, however laser light may kill the fungal infection within and under the nail tissue, but it does not remove the abnormal nail tissue. From my perspective laser therapy alone will fail to resolve the infection or reinfection if there is not additional treatment for a minimum of 8-12 months, a time it takes a completely new nail to grow. If and when a new healthy appearing nail grows completely, then discontinue the supplemental treatment and assess the nail periodically for recurrence is appropriate. Again the prognosis for resolution of the infection seems to hinge on the whether or not the nail matrix has been infected. Regardless of your choice to treat the nail, this seems to be a reasonable procedure to determine if a nail infection will resolve. I have moved to the use of laser treatment for fungal infection of nails because based on the science of the laser and penetration of the light and killing temperature, it makes sense as a good addition to the aramentarium in the treatment of this common and unsightly condition. By the way, I would agree with Dr. Kirby, this condition is partly a cosmetic condition, but unsightly ugly nails is nothing a women who cares about her appearance wants to live with. So treat the condition and take it as seriously as your patients do.
The Following User Says Thank You to i-man For This Useful Post:
.... Regardless of the treatment used, if the nail matrix has been infected it will usually produce abnormal nail tissue that has lost its resistance to fungal organisms and the recurrence rate increases. If this is the case, then treatment of the fungal infection is a management issue and will not be cured. .... If and when a new healthy appearing nail grows completely, then discontinue the supplemental treatment and assess the nail periodically for recurrence is appropriate. Again the prognosis for resolution of the infection seems to hinge on the whether or not the nail matrix has been infected....
Agreed. Clinical `cure` can be obtained with a variety of anti-fungal treatments, whether they be pharmaceutical, laser, avulsion, etc. However, recurrence of symptoms is high in these individuals due to environmental, genetic, immune system and other factors, so management of the dermatophytes is key, IMO.
Quote:
Originally Posted by i-man
..I would agree with Dr. Kirby, this condition is partly a cosmetic condition, but unsightly ugly nails is nothing a women who cares about her appearance wants to live with. So treat the condition and take it as seriously as your patients do.
It also important to stress the fact that dermatophytes are opportunistic pathogens. They will only invade a damaged/compromised nail plate, so resolution of the infection will not necessarily change the `look` of a previously damaged/thickened nail.
The purpose of this study is to determine whether low level laser light is effective in the treatment of toenail fungus.
Quote:
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Evaluation of the Effect of the Erchonia FSS™ on Treating Toenail Onychomycosis Clinical Study
I've not been able to find the treatment parameters used in the PinPointe FootLaser data.
Has anyone here seen this data?
What were the pulse width, fluence, spot size and number of pulses? Was debridement done?
Can someone post a link to an article? The FDA approval doc linked earlier in this thread mentions nothing about the treatment protocol used.
Basheer Badiei, MD
I think you have asked a key point. Until we have a sense of appropriate dose it will be difficult to design a proper study. Any users out there care to comment on their anecdotal experiences?
Re: Laser treatment for nail fungus
One of the two sources cited is the same journal article that Fotona regularly uses to espouse near 100% success.
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