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Peer-reviewed antifungal data for Onychomycosis Lasers

Discussion in 'General Issues and Discussion Forum' started by Dr. Eric Bornstein, Mar 30, 2014.

  1. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member


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    Dear Colleagues:

    Here is new thread dedicated to discussing the peer-reviewed and published Antifungal data that is available concerning Onychomycosis and laser systems.

    I am posting this so the DPMs can compare and contrast the published efficacy of various systems.


    Nd:YAG Lasers:

    2011:

    Hochman treated eight patients with a total of two to three treatments spaced 3 weeks apart (223 J/cm2, 0.65 ms, 2-mm spot size, two passes), and patients were instructed to apply topical antifungal cream between sessions to prevent reinfection. Seven out of eight patients (87.5 %) had negative cultures after the final treatment.

    Hochman LG (2011) Laser treatment of onychomycosis using a novel 0.65-millisecond pulsed Nd:YAG 1064-nm laser. J Cosmet Laser Ther: official publication of the Eur Soc Laser Dermatol 13 (1):2–5.


    2012:

    Kimura et al treated 13 patients (total of 37 nails) with either two or three treatments at 4 or 8 week intervals (14 J/cm2, 0.30 ms, 5-mm spot size, two passes). 51 % showed microscopically negative complete clearance at 6-month follow-up.

    Kimura U, et al. (2012) Treating onychomycoses of the toenail: clinical efficacy of the sub-millisecond 1,064 nm Nd: YAG laser using a 5 mm spot diameter. J Drugs Dermatol:


    Hees et al tested anti-fungal activity in a range of Nd:YAG systems. They tested Q-switched and long-pulsed Nd:YAG laser systems at the following parameters.

    Taking shavings from T. rubrum-affected nails, they were cultured and treated with:

    1) Q-switched 1,064 nm at 4 and 8 J/cm2 (2-mm spot size, 6-ns pulse duration),

    2) Q-switched 532 nm at 8 J/cm2 (2-mm spot size,6-nspulseduration),

    3)Long-pulsed1,064nmat45J/cm2 (10-mm spot size, 40-ms pulse duration) and 100 J/cm2
    (3-mm spot size, 40-ms pulse duration).

    No inhibitory, fungicidal, or fungistatic effects could be seen.

    Hees H, Raulin C, Baumler W (2012) Laser treatment of onychomycosis: an in vitro pilot study. Journal der Deutschen Dermatologischen Gesellschaft0J Ger Soc Dermatol: JDDG


    2013

    Methods

    A 4-part in vitro and in vivo study was conducted using a Nd:YAG 1064-nm laser. The first portion evaluated 3 different nail pathogens in suspension at 7 heat and time exposures. The second and third parts of the study irradiated pure fungal colonies. The final portion involved an in vivo treatment of toenails over 5 treatment sessions.

    Results

    A fungicidal effect for Trichophyton rubrum was seen at 50°C after 15 minutes, and for Epidermophyton floccosum at 50°C (122 °F) after 10 minutes. Limited growth of Scytalidium was seen at 55°C (131 °F) after 5 minutes. No inhibition was observed after laser treatment of fungal colonies or suspensions. In vivo treatment of toenails showed no improvement in Onychomycosis Severity Index score.

    Glaser, Heather Joy, Craig Lockwood, and Karolina Lisy. "The effectiveness of laser treatments for onychomycosis in adults in the community: a systematic review protocol." The JBI Database of Systematic Reviews and Implementation Reports 11.10 (2013): 1-15.


    Abstract

    Materials and methods:

    Lasers of 808, 980 and 1064 nm were used to heat cell culture media and a nail clipping. Trichophyton rubrum. T. interdigitale. Microsporum gypseum. Candida albicans. C. parapsilosis, and C. guilliermondii species were subcultured and subjected to laser treatments (808/980 nm: 9–27 J/cm2, 6 ms, 12 × 12 or 12 × 50 mm and 1064 nm: 50–240 J/cm2, 90 ms, 5–10 mm). After irradiation, the fungal elements were transferred onto agar plates using conventional and Drigalski spatulas and were incubated for 6 days.

    Conclusions:
    This study demonstrates a clear thermal effect for linear scanning 980-nm and long-pulsed 1064-nm laser systems on either nail clippings or cell culture media. Complete pathogen growth impairment was achieved if temperatures were measured above 50 °C (122 ºF). The results for the 1064-nm system were almost comparable to 980 nm results.

    Paasch, Uwe, et al. "Antifungal efficacy of lasers against dermatophytes and yeasts in vitro." International Journal of Hyperthermia 29.6 (2013): 544-550.


    2014:

    Methods:

    This was a randomized, controlled, single-center trial comparing 2 treatments with 1064-nm laser (fluence of 5 J/cm2, rate of 6 Hz) spaced 2 weeks apart versus no treatment in 27 patients (N = 125 affected nails) with clinical and mycological diagnosis of onychomycosis. At 3 months, patients were assessed with mycological cultures and proximal nail plate measurements. Patients treated with laser were also assessed with proximal nail plate measurements at 12 months.

    Results

    At 3 months, 33% of patients treated with laser achieved a negative mycological culture compared with 20% of the control group (P = .49), and had more proximal nail plate clearance compared with control subjects (0.44 vs 0.15 mm, P = .18), which was not statistically significant. At 12 months, there was no difference in nail plate clearance between laser versus control subjects (0.24 vs 0.15 mm, P = .59).

    Hollmig, S. Tyler, et al. "Lack of efficacy with 1064-nm neodymium: yttrium-aluminum-garnet laser for the treatment of onychomycosis: A randomized, controlled trial." Journal of the American Academy of Dermatology (2014).



    Nomir Medical – Noveon Nail laser


    (2008)

    Bornstein ES, Robbins AH, Michelon M:Photo-Inactivation of Fungal Pathogens That Cause Onychomycosis In Vitro And In Vivo With The NoveonDual Wavelength Laser System. Abstract presented at New Cardiovascular Horizons, New Orleans, LA,2008

    In this early pilot study, six out of six patients showed Mycologic negative culture after 60 days and 4 Noveon treatments on day 1, 7, 14 and 60. Temperatures did not raise above 102 F (39 C)


    (2009)

    A full battery of lab controlled in vitro anti-fungal analysis was completed to prove the non-thermal photobiology of our Noveon system.

    This in vitro study showed in Sextuplicate, 100% kill of T. rubrum and C. albicans at temperatures that were not detrimental to the fungi (40-42 C) (104 F - 107 F)

    Methods:

    After multiple temperature trials, the theoretical threshold dosimetry for photo-inactivation experiments was chosen as 12 min (720 s) with blended 10 W (5 W of each wavelength) producing an energy density of 4074 J cm) 2 with a flat-top projection. This uniform energy dose consistently produced a temperature steady-state limit of 42.5 C. This temperature limit was chosen with examination of data from the literature, describing normal growth for the species we tested at the experimental time⁄temp parameters:

    (1) 42.5 C is within the thermal tolerance maxima for seven different species of keratinophilic fungi (Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, T. interdigitale and T. rubrum. *

    * Saez, H. and M. R. Battesti (1972) Mycelial growth of dermatophytes in vitro for specific diagnosis. Apropos of a trichophytic onychosis. Ann. Dermatol. Syphiligr.99, 501–509.


    In vitro T. rubrum photoinactivation experiments Two equivalent samples of T. rubrum cells were exposed to blended laser energy for 12 min irradiation cycles. The first was exposed to 4074 J cm) 2 and plated in triplicate, and the second was exposed to 4500 J cm) 2 and plated in triplicate. Both exposures to T. rubrum produced photoinactivation of 100% of the colony forming units counted at 91 h incubation versus control.

    In vitro C. albicans photoinactivation experiments Two equivalent samples of C. albicans cells were exposed to blended laser energy for 12 min irradiation cycles. The first was exposed to 4074 J cm) 2 and plated in triplicate, and the second was exposed to 4500 J cm) 2 and plated in triplicate. Both of the exposures to C. albicans produced photoinactivation of 100% of the colony forming units counted at 20 h incubation versus control.

    Bornstein, Eric, et al. "Near‐infrared Photoinactivation of Bacteria and Fungi at Physiologic Temperatures." Photochemistry and photobiology 85.6 (2009): 1364-1374.

    2010

    Negative culture was noted in 42% of toes after only one treatment and attained a peak of 75% on day 60, whereas a peak of 64% negative periodic acid–Schiff staining was attained at day 120.

    The ability of the device to directly affect the fungi causing onychomycosis in the patients in this trial was demonstrated by the fact that after only one treatment, negative culture was observed in 42% of the eligible toes that had positive cultures at the outset and that by day 60, after three 6-minute treatments, 75% showed negative culture. These observations are clear indicators of therapeutic success from which future regimens can be modified to further optimize the laser’s mycologic impact.

    Landsman, Adam S., et al. "Treatment of mild, moderate, and severe onychomycosis using 870-and 930-nm light exposure." Journal of the American Podiatric Medical Association 100.3 (2010): 166-177.

    (2012)

    Review of 270-day mycological data, confirmed that there was further decrease in both measures. Indeed, 38% of the treated population had negative culture and microscopy, qualifying as ‘‘mycological cures.’’

    These mycological cures occurred in cases categorized as mild, moderate, and even severe disease. (J Am Podiatr Med Assoc 102(2): 169-171, 2012)

    The observed trend line of decreasing positivity of each is corroborated by a steady increase in the number of toes with simultaneous negative culture and PAS (‘‘mycologicalcure’’).

    Importantly,at the 270-day mark, 38% of all treated toes were mycologically cured. The severity of the disease at the outset of treatment of those 15 toes was: 33% mild, 20% moderate, and 47% severe.

    There are two important conclusions to be drawn from this review of the available 270-day data:

    1. Indication of persistent infection in the treated population continued to fall throughout the 270 day follow-up period as measured by culture, by microscopy of PAS-stained nail samples, or by both in combination.

    2. In addition, the data clearly show this outcome can be effected regardless of the severity of the disease. As such, it gives strong indication that the Noveon laser offers a unique, low-risk option to potentially eliminate and then control the infecting fungal agent.

    Landsman, Adam S., and Alan H. Robbins. "Treatment of Mild, Moderate, and Severe Onychomycosis Using 870-and 930-nm Light Exposure Some Follow-up Observations at 270 Days." Journal of the American Podiatric Medical Association 102.2 (2012): 169-171.

    The data from the 2010 and 2012 JAPMA studies were taken with treatment of only the Halux, with all other mycotic toes not treated on the same foot, as per the criteria of the study.

    This is even more impressive, as the ability of cross-contamination from other adjacent and non-treated toes was prevalent during the entire 180 day and 270 follow-up day periods, and there were still significant improvement and long term negative mycology present in the treated toes.


    Discussion and comments are welcome.


    Dr. Eric Bornstein
    www.noveoninternational.com
    ebornstein@nomirmedical.com
     
  2. Admin2

    Admin2 Administrator Staff Member

  3. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member

    New timely article and advice:

    Trelles, Mario A. "Scientific Rigor and Strategic Vision Are the Key Points for Going Forward in Photomedicine." Photomedicine and laser surgery (2014).

    "There are no other choices than scientific rigor, personal enthusiasm, and strategic vision, to go for- ward in photomedicine. Without these, chances would be missed to use light therapeutically to generate health and well-being in individuals."

    "Advances are already here; a combination of photosensitive drugs and sophisticated devices will make it possible for light to easily interact with tissue and to modify biological processes."

    "We need to consider that the transfer of information between colleagues implies generosity and scientific maturity. Therefore, communication of data should be transparent, concise, easy to interpret, and practical to apply."

    "With the clinical application of light as a therapy it is not enough to only make observations public, it is also important to explain in detail how the process took place. It is necessary to give a hypothesis aiming to clarify the phenomenon of the physical nature observed. If this does not occur, then observations risk becoming discredited and losing their clarity, specific acceptance, and clinical
    function."

    Be observant, keeping in mind what Albert Einstein once said: ‘‘If you are expecting better results than those that others have obtained, do not walk down the path they did.’’

    Dr. Eric Bornstein
    ebornstein@nomirmedical.com
    www.noveoninternational.com
     
  4. blinda

    blinda MVP

    Dear Dr. Bornstein,

    Thank you very much for your recent posts on laser treatment for OM, which I have read with great interest.

    I`m all for evidenced based scientific research, so please do continue to contribute such data. However, testimonials and hype leave no impression other than leaving me cold and cynical. Just a thought.

    Kind regards,
    Belinda Longhurst
     
  5. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member

    Thank you Belinda.

    Absolutely agree with both positions.

    I am partial to evidenced based scientific research and data. As more science and data presents itself in this arena, I am more than happy to publish, present, and discuss it from wherever it may come. :)



    Bornstein, E.S., A.H. Robbins, M. Michelon (2008) 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.

    Bornstein E.S. (2009) 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.

    Bornstein E.S. (2009) A Review of current research in light-based technologies for treatment of podiatric infectious disease states. J. of the Am. Pod. Med. Assoc. 99 (4), 348-352.

    Landsman, A. S., Robbins, A. H. et al(2010). Treatment of mild, moderate, and severe onychomycosis using 870-and 930-nm light exposure. Journal of the American Podiatric Medical Association, 100(3), 166-177.

    Bornstein, Eric. (2010) "Emphasizing The Importance Of EBM When It Comes To Laser Care For Onychomycosis." Podiatry Today, Volume 23 - Issue 10 - October 2010

    Bornstein E and Gridley S., (2010) 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

    Landsman, Adam S., and Alan H. Robbins. (2012) "Treatment of Mild, Moderate, and Severe Onychomycosis Using 870-and 930-nm Light Exposure Some Follow-up Observations at 270 Days." Journal of the American Podiatric Medical Association 102.2 : 169-171.
     
  6. blinda

    blinda MVP

    Thank you for your courteous reply, Dr Bornstein.

    I`m hoing that your being "partial to evidenced based scientific research and data" is tongue in cheek, as this is the support upon which we base our treatment plans, right?

    So, as Original Poster of this thread entitled "Peer-reviewed antifungal data for Onychomycosis Lasers", let`s stick with peer-reviewed evidence, eh?

    Have a great weekend :drinks

    Cheers,
    Bel
     
  7. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member

    Another new Dose/response Nd:YAG - antifungal article:

    This shows that Nd:YAG energy is fungicidal, but at far higher Energy Densities (J/cm2) than could be tolerated by human tissues.


    Abstract: Objective To observe the effect of 1064nm Nd:YAG laser irradiation on the growth of 5 main pathogenic fungi of onychomycosis including Trichophyton rubrum, Trichophyton mentagrophytes, Candida albicans, Candida parapsilosis, Aspergillus fumigatus.Methods Suspension of T.rubrum,T.mentagrophytes,C.albicans,C.parapsilosis were spotted on ager media. After incubation for several days, the colonies were exposed to various energies of 1064nm Nd:YAG laser. For T.r and T.m, diameters of colonies were measured on the first, third, and sixth days after laser irradiation. For C.a and C.p, the subculture's survival rates of different energies of laser irradiation were assessed respectively. As for A.fumigatus, having been incubated on the whole plate, to compare the different diameters of circular growth-free zones after different energies of laser treatment.

    Result In vitro, when the laser energy reaching 3 200 J/cm2, the growth of five pathogenic fungi of onychomycosis could be inhibited significantly. And the higher the laser energy was, the more significant the inhibition would be, and even pathogenic fungi would be killed. Conclusion When the energy of 1064nm Nd:YAG laser reaching a certain amount, the pathogenic fungi of onychomycosis could be inhibited significantly or be killed.

    Institute of dermatology and fungal disease, Key Laboratory of the army fungal disease, Department of dermatology, Changzheng Hospital, Shanghai 200003

    CHEN Li-hua, et al. , Effects of 1064nm Nd:YAG laser irradiation on 5 main pathogenic fungi of onychomycosis. Chinese Journal of fungus 2013, 8 (4) 205-209 DOI: ISSN: 1673-3827 CN: 31-1960
     
  8. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    The effectiveness of lasers in the treatment of onychomycosis: a systematic review
    Ivan R Bristow
    Journal of Foot and Ankle Research 2014, 7:34 doi:10.1186/1757-1146-7-34
     
  9. Lab Guy

    Lab Guy Well-Known Member

    Conclusions
    The evidence pertaining to the effectiveness of laser treatment of onychomycosis is limited and of poor methodological quality. Future studies using a randomised controlled trial designs with larger study populations and clear procedures are required to permit a full evaluation of this emerging technology

    Wow, what a surprise. I wish that Podiatrists would be paid fair reimbursement for the important services they provide so they don't have to go down this laser marketing road to attract cash paying patients.

    Steven
     
  10. NewsBot

    NewsBot The Admin that posts the news.

    Articles:
    1
    Laser therapy of onychomycosis.
    Nenoff P, Grunewald S, Paasch U.
    J Dtsch Dermatol Ges. 2014 Jan;12(1):33-8
     
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