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I apologize for missing the placebo part of the question the first time. My mistake.
Let my expand on the study parameters to address your question directly.
The control subjects in the pivotal FDA onychomycosis study were treated identically in all respects to subjects that were actually treated with the laser, with the exception that when a sham (placebo) “laser treatment” was delivered, the device put forth no energy output, (that is the laser power was set to zero).
The study was single blinded (the patient did not know if they were being treated or not). It was not “double blinded” as the technician running the device did know whether the machine was delivering energy or not.
The device “beeped” in the exact same manner as the real treatment during placebo, the time was the same, and the set-up was the same.The patients had no idea if they were in the treatment phase or the control phase. This is possible because of the minimal heat produced from the procedure at low power densities (discussed in a prior post)
Further, there was an independent expert panel of podiatrists (to evaluate the results) that used baseline (Day 0) photographs to classify each toe in the study as either mild, moderate or severe involvement at the outset. The members of the panel were blinded as to which photographs came from treated patients or control patients.
Follow-up photographs were used by the same panel to subjectively grade clinical improvement, and sophisticated computer software was used to measure outlines that the panel members made of improvement, no-improvement, or regression.The members were again blinded as to which photographs came from treated patients or control.
The data was statistically analyzed and produced by an independent CRO that is certified to perform this function for the FDA.
I hope that this further explanation answers your questions.
Eric Bornstein
Chief Science Officer
Nmir Medical Technologies
The Following User Says Thank You to Dr. Eric Bornstein For This Useful Post:
I apologize for missing the placebo part of the question the first time. My mistake.
Let my expand on the study parameters to address your question directly.
The control subjects in the pivotal FDA onychomycosis study were treated identically in all respects to subjects that were actually treated with the laser, with the exception that when a sham (placebo) “laser treatment” was delivered, the device put forth no energy output, (that is the laser power was set to zero).
The study was single blinded (the patient did not know if they were being treated or not). It was not “double blinded” as the technician running the device did know whether the machine was delivering energy or not.
The device “beeped” in the exact same manner as the real treatment during placebo, the time was the same, and the set-up was the same.The patients had no idea if they were in the treatment phase or the control phase. This is possible because of the minimal heat produced from the procedure at low power densities (discussed in a prior post)
Further, there was an independent expert panel of podiatrists (to evaluate the results) that used baseline (Day 0) photographs to classify each toe in the study as either mild, moderate or severe involvement at the outset. The members of the panel were blinded as to which photographs came from treated patients or control patients.
Follow-up photographs were used by the same panel to subjectively grade clinical improvement, and sophisticated computer software was used to measure outlines that the panel members made of improvement, no-improvement, or regression.The members were again blinded as to which photographs came from treated patients or control.
The data was statistically analyzed and produced by an independent CRO that is certified to perform this function for the FDA.
I hope that this further explanation answers your questions.
Eric Bornstein
Chief Science Officer
Nmir Medical Technologies
Thanks. Just a couple more questions: how many subjects were employed in the study? Did they just receive either laser / no laser or was adjunctive therapy employed? Was expert grading of photographs the only outcome or were cultures performed?
__________________ Science is the antidote to the poison of enthusiasm and superstition
Thanks. Just a couple more questions: how many subjects were employed in the study? Did they just receive either laser / no laser or was adjunctive therapy employed? Was expert grading of photographs the only outcome or were cultures performed?
Dr. Spooner:
There were 36 subjects (53 Toes) enrolled in the study.
Starting after the completion of the second of the four treatments, all subjects were required to use a non-prescriptive topical agent: 1% topical terbinafine cream applied only between the toes to control or prevent tinea interdigitalis.
Patients were instructed to not get any cream on the nails.
Use of this topical between the toes only, was in accordance with the current listed product information and is neither FDA indicated, nor FDA cleared as a treatment for onychomycosis. Other adjunctive actions that are "standard of care", such as nail debridement or nail trimming, were allowed at each investigator’s discretion.
The control subjects were again handled identically in all respects to those who were treated, except for, of course, sham “treatment” with no energy delivery. The highest treatment site temperature was 100.5°F.
All study subjects had to have laboratory confirmation of onychomycosis by either positive culture using a selective dermatophyte test medium, or positive periodic acid-Schiff staining (PAS) from a toenail sample. The mycology was also followed and data taken for the balance of the study that lasted 180 days.
The top-line preliminary 120-day data analysis that I presented at the Council for Nail Disorders 13th Annual Scientific Meeting demonstrated that after Noveon treatment, 76.3 percent of the treated toes showed evidence of clinical improvement (p<0.02), and a significant drop in positive culture was seen in 74 percent of the treated toes after only two treatments (before the introduction of the tinea pedis cream.)
This data was based on at least 120 days of follow-up on all enrolled patients. Additionally, no significant adverse events were reported.
I must hold out on discussing the final 180 day data, as it is currently under review by the FDA, and we are also under agreement with the peer-review journal that has decided to publish the final results.
Thank you for your interest and the questions.
Eric Bornstein
Chif Science Officer
Nomir Medical Technologies
I must hold out on discussing the final 180 day data, as it is currently under review by the FDA, and we are also under agreement with the peer-review journal that has decided to publish the final results.
Thank you for your interest and the questions.
I look forward to reading this. Thanks for your answers. One final question: how much would it cost for me to have one of these systems in my practice?
__________________ Science is the antidote to the poison of enthusiasm and superstition
I look forward to reading this. Thanks for your answers. One final question: how much would it cost for me to have one of these systems in my practice?
Dr. Spooner:
Thank you for your interest in the Noveon system.
I would like to direct you to the nomirmedical.com web site, and ask you to use the “contact us” page to inquire about the Noveon Academy.
Due to FDA regulations prohibiting the sale of a medical device in the United States for an uncleared indication, the Noveon system is currently not for sale for the treatment of onychomycosis.
As we have completed our IRB controlled pivotal study, a 510(k) clearance has been applied for from the Center for Devices and Radiological Health (CDRH), the branch of the FDA that oversees the 510(k) process.
I see there is yet another video clip up on You Tube touting this treatment. They also claim it has FDA approval - why do they that?
__________________
Craig Payne
Department of Podiatry
La Trobe University
Melbourne, Australia http://www.latrobe.edu.au/podiatry
__________________________________________________ ___________________________________ 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 views expressed above are those of the author and not that of La Trobe University This is where I am, where are you?
Here (below) is an excellent article about the perils of a doctor teaching and/or using medical devices on patients, off label from thier intended FDA indication in the United States.
Any DPM, MD or Dentist in the United States, that is using a device "off label" for any reason, should give this article a thorough read.
A few of the more important points (in my opinion) that the article makes regarding US medical device law are:
1) Using any devices or off-label products is prohibited if your primary objective is to test a hypothesis or obtain general knowledge. Those situations require that you conduct a study under Human Subjects Protection, Institutional Review Board (IRB), or other oversight.
2) Off-label use can be justified when convincing clinical data and research support off-label use (conducted under an IRB, peer-reviewed and published) and when those data are available ahead of regulatory approval.
These laws of course apply to all lasers and onychomycosis therapy. Hence, the Noveon has only been used to conducted IRB approved MRSA and Onychomycosis studies, that have then been peer-reviewed and published as such.
I am admitedly not as familiar with European and Australian laws.
Eric Bornstein
Chief Science Officer
Nomir Medical Technologies
My issue (as I have stated many times) is the way its being touted. Here is a cut and paste from message 2 at the start of this thread from the New York Times:
Quote:
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.
I just do not get why the claims that FDA have approved it for onychomycosis are being made on You Tube (...actually I do sort of know, and thats why they using You Tube ... and Google owns You Tube .... and Google have a corporate motto of 'Do no evil'... so if its on You Tube, then it must be correct)
__________________
Craig Payne
Department of Podiatry
La Trobe University
Melbourne, Australia http://www.latrobe.edu.au/podiatry
__________________________________________________ ___________________________________ 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 views expressed above are those of the author and not that of La Trobe University This is where I am, where are you?
When podiatrists are making $1,000+ cash for a procedure that takes them less than an hour (more like 30 minutes) to perform in their offices, it doesn't take a rocket scientist to figure out why it is being advertised so heavily by many podaitrists even though it doesn't have FDA approval or any published studies regarding its efficacy.
__________________
Sincerely,
Kevin
**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College
When podiatrists are making $1,000+ cash for a procedure
I stand to be corrected on this, but my understanding is that the business model for the PinPointe device is that they have to pay the company (Patholase) $250 every time they use it.... ... there were several DPM's at the PFOLA mtg talking about this.
__________________
Craig Payne
Department of Podiatry
La Trobe University
Melbourne, Australia http://www.latrobe.edu.au/podiatry
__________________________________________________ ___________________________________ 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 views expressed above are those of the author and not that of La Trobe University This is where I am, where are you?
Due to FDA regulations prohibiting the sale of a medical device in the United States for an uncleared indication, the Noveon system is currently not for sale for the treatment of onychomycosis.
As we have completed our IRB controlled pivotal study, a 510(k) clearance has been applied for from the Center for Devices and Radiological Health (CDRH), the branch of the FDA that oversees the 510(k) process.
However, in the interim, the Noveon Academy can provide you with more information on the Noveon therapy, its practice and clinical implementation.
If you wish to contact me directly, please feel free to do so by email.
It has been a pleasure sharing our science and data with you in the Podiatry Arena.
Eric Bornstein
Chief Science Officer
Nomir Medical Technologies ebornstein@nomirmedical.com
(P) (781) 893-1000
Dr. Spooner:
I wanted to further bring the Podiatric community up to date on current laser studies approaching the Onychomycosis disease paradigm.
Here is a very nice modern in vitro study (2008) describing pulsed laser effects on T. rubrum in vitro.
Vural E. et al. The effects of laser irradiation on trichophyton rubrum growth. Lasers Med Sci 2008 Oct;23(4):349-53
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/cm(2) and 532-nm Q-switched Nd:YAG laser at 8 J/cm(2). 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.
These are the wavelengths, and fluences used during the initial phase of the study
In this well done study in vitro study, the Q-switched 532 nm light (visible green), in the Nd:YAG family, was superior to all other systems in T. rubrum inhibition. This Q-switched system pulses in nano-seconds, A nanosecond (ns) is one billionth of a second (10-9 s).
The only problem is, that 532 nm also has less than half the penetration value through the nail (i.e. to the bed and matrix) of near-infrared wavelengths, because of a very high protein absorption coefficient in the keratin.
The study authors concluded with this statement:
“In addition to more in vitro studies, in-vivo studies are necessary to investigate the possible therapeutic effects of various laser systems on various dermatopathogens, as laser–fungus interaction might be different when these microorganisms are embedded within the skin and its adnexa.”
Very nice science.
Eric Bornstein
Chief Science officer
Nomir Medical Technologies
I wanted to further bring the Podiatric community up to date on current laser studies approaching the Onychomycosis disease paradigm.
Here is a very nice modern in vitro study (2008) describing pulsed laser effects on T. rubrum in vitro.
Vural E. et al. The effects of laser irradiation on trichophyton rubrum growth. Lasers Med Sci 2008 Oct;23(4):349-53
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/cm(2) and 532-nm Q-switched Nd:YAG laser at 8 J/cm(2). 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.
These are the wavelengths, and fluences used during the initial phase of the study
In this well done study in vitro study, the Q-switched 532 nm light (visible green), in the Nd:YAG family, was superior to all other systems in T. rubrum inhibition. This Q-switched system pulses in nano-seconds, A nanosecond (ns) is one billionth of a second (10-9 s).
The only problem is, that 532 nm also has less than half the penetration value through the nail (i.e. to the bed and matrix) of near-infrared wavelengths, because of a very high protein absorption coefficient in the keratin.
The study authors concluded with this statement:
“In addition to more in vitro studies, in-vivo studies are necessary to investigate the possible therapeutic effects of various laser systems on various dermatopathogens, as laser–fungus interaction might be different when these microorganisms are embedded within the skin and its adnexa.”
Very nice science.
Eric Bornstein
Chief Science officer
Nomir Medical Technologies
Eric:
Thanks for being so helpful to all of us regarding the photo-physiology of lasers. Your knowledge is impressive.
My question to you is this. Why couldn't the scientists involved with the other laser fungal toenail treatment system also come onto Podiatry Arena to give us their opinions of why patients should be spending $1,000+ to have their toenails treated with a technology that has not received FDA approval for onychomycosis and does not have any published studies regarding its clinical efficacy?
__________________
Sincerely,
Kevin
**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College
Thanks for being so helpful to all of us regarding the photo-physiology of lasers. Your knowledge is impressive.
My question to you is this. Why couldn't the scientists involved with the other laser fungal toenail treatment system also come onto Podiatry Arena to give us their opinions of why patients should be spending $1,000+ to have their toenails treated with a technology that has not received FDA approval for onychomycosis and does not have any published studies regarding its clinical efficacy?
Dr. Kirby:
This may also be of interest to you.
Researchers are also attempting other light-based modalities in the Dermatophyte/Onychomycosis arena.
Here is a list of references in the photodynamic therapy realm (i.e. light plus active chemical).
Any approvals for these systems is considered a "combinatorial" device by the FDA, and would require much larger safety studies, than a device alone.
Propst, C. and L. Lubin (1978) In vitro and in vivo photosensitized inactivation of dermatophyte fungi by heterotricyclic dyes. Infect. Immun. 20, 136-141.
Calzavara-Pinton, P. G., M. Venturini, R. Capezzera, R. Sala, and C. Zane (2004) Photodynamic therapy of interdigital mycoses of the feet with topical application of 5-aminolevulinic acid. Photodermatol. Photoimmunol. Photomed. 20, 144-147.
Kamp, H., H. J. Tietz, M. Lutz, H. Piazena, P. Sowyrda, J. Lademann, and U. Blume-Peytavi (2005) Antifungal effect of 5-aminolevulinic acid PDT in Trichophyton rubrum. Mycoses 48, 101-107.
Calzavara-Pinton, P. G., M. Venturini, and R. Sala (2005) A comprehensive overview of photodynamic therapy in the treatment of superficial fungal infections of the skin. J. Photochem. Photobiol. B 78, 1-6.
Donnelly, R. F., P. A. McCarron, M. M. Tunney, and W. A. David (2007) Potential of photodynamic therapy in treatment of fungal infections of the mouth. Design and characterisation of a mucoadhesive patch containing toluidine blue O. J. Photochem. Photobiol. B 86, 59-69.
Calzavara-Pinton, P., M. Venturini, and R. Sala (2007) Photodynamic therapy: update 2006 Part 1: Photochemistry and photobiology. J. Eur. Acad. Dermatol. Venereol. 21, 293-302.
Gad, F., T. Zahra, K. P. Francis, T. Hasan, and M. R. Hamblin (2004) Targeted photodynamic therapy of established soft-tissue infections in mice. Photochem. Photobiol. Sci. 3, 451-458.
Altenburg, B. and G. M. T. Smijs (2006) Use of a porphyrin compound for the treatment of skin fungi. PCT patent application.
Eric Bornstein
Chief science Officer
Nomir Medical Technologies
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:(((
CBS Atlanta are reporting: Tough Questions About Foot Fungus Laser Treatment
CBS Atlanta Questions Local Podiatrist About PinPointe Laser Treatment
Quote:
The Ankle and Foot Centers of Georgia has been promoting a foot fungus laser treatment on its Web site.
Mary Long with the FDA said, "The PinPointe Laser has been cleared for marketing by the FDA for soft tissue cutting. It has not been cleared or approved by the FDA for the treatment of toenail fungus."
However, the Ankle and Foot Centers of Georgia is advertising the foot fungus laser treatment online and it even claims it's 88 percent effective. CBS Atlanta questioned the Piedmont Podiatry about the promotion at their Atlanta practice and they shut the door on us.
The FDA said that doctors can use the laser for any type of treatment, but they are not able to advertise treatments that are not FDA approved.
"Promotion of medical devices for unapproved or uncleared uses violates FDA regulation," said Long.
The Ankle and Foot Centers of Georgia told CBS Atlanta Tuesday that the FDA guidelines for promotion of the PinPointe Laser only apply to the manufacturer.
The FDA responded with this statement, "No, it does not only apply to manufacturers. Section 906 of the Food, Drug and Cosmetic Act refers to our authority over promotion of unapproved uses of legally marketed devices by practitioners."
If the FDA decides to take action, the Ankle and Foot Centers of Georgia could lose its laser.
That is funny! Isn't the contrast between this media clip and the others earlier in this thread amazing? Good to see the media asking hard questions compared to giving others a free ride to promote the tool.
The FDA approved PinPointe FootLaser is a specially designed laser beam that goes through the toenail and safely kills the organisms embedded in the nail bed that cause Onychomycosis
Re: Laser treatment for nail fungus
... there were several DPM's at the PFOLA mtg talking about this.
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