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03/07/2013    Tip Sullivan, DPM

Efficacy of Lasers for Onychomycosis

Last year, I became interested in finding out
about the clinical side of the effect laser had
on fungal nails. I thought it may be a good way
to get outside of the system and do a cash
business like the local plastic surgeons and
dermatologists are doing. The purchase of a
laser ranging from about $40K to $90K is a big
step for me and I am a kinda “prove it” type of
guy. After digging through all the papers I
could find with clinical outcome (sparse) there
remained a doubt as to the effectiveness of this
expensive modality.


Being a skeptic at heart, I made a deal with a
laser company to provide the free use of a laser
for treatment of some patients. I used their
protocol of two treatments separated by 3
months. There was an agreement with my patients
that they only treat this fungus mechanically
and topically. Cultures were obtained before the
treatment course to document the presence of a
fungus. 25 or so patients were seen on 10/31/12,
7/10/12 and again on 1/30/13. Pictures were
taken and stored. This was not done with the
intention of publishing a study.


The number of my patients was small (only 10 or
11 finished the treatment and returned for final
pictures) and there certainly are multiple
variables that one could consider. This was done
to help me make a decision as to whether or not
a laser (NdYag-1064) would help those patients
that I see day in and day out who chose not to
take oral meds . While I do not doubt the
financial potential of jumping on the bandwagon
of new treatment modalities from a business
standpoint I can tell you that the few patients
that I followed did not have any significant
improvement over the 6 month period and if I
would have charged them $400 to $800 for the
treatment I would have developed a less than
desirable result which would have been related
to the local doctors that refer me patients and
ultimately would have been detrimental to my
practice.


I would like to re-emphasize that this is simply
my opinion and not a peer reviewed bona fide
research project. I did not send any of this for
publication, no statistical analysis, no
calipers to measure nail growth but I will be
happy to send the pictures to those who ask- pts
were consented before treatment and are
identified only by treatment numbers in the
pictures. As with many other things: lasers may
work well in some hands but not mine. The
courses seemed so easy. For me, I am going to
need significantly more convincing before I
plunk down a cool $90K on this modality.


Tip Sullivan, DPM, Jackson, MS,
tsdefeet@MSfootcenter.net


Other messages in this thread:


03/13/2013    Scott Nelson, DPM

Efficacy of Lasers for Onychomycosis

In my two-year experience with using lasers for
onychomycosis, I have found that the largest
underlying reason the laser may not get the
desired results is under-treatment of the
nails. Patient compliance remains another
challenge. For instance, if you treat the nails
and the patient still wears that favorite pair
of shoes without attempting to eradicate the
dermatophytes from these same shoes, then the
results may be less than desirable.


To avoid under treatment, choosing the right
laser for your practice is paramount in your
success rate. If you choose lasers with lower
wattage output (i.e., 4 watt), then you need to
be prepared to treat the patient for a full hour
or more to get effective results. If the laser
is too powerful (60 watts), you can still under-
treat the nail because the patient is more
sensitive to the energy being administered to
their nails and may not be able to tolerate a
complete treatment.


An important note is that The larger power units
require treatment from the doctor only. The
lasers using power in the middle of these
extremes seem to be achieving some of the best
results. The energy is enough for the patient to
feel, which will eliminate over treatment, but
enough energy to get a complete effective
treatment. These middle and lower powered lasers
can be administered by office staff under your
supervision.


Personally, I wanted an effective treatment
without tying up my treatment room for an hour
or not hurting the patient with too much power.
I have been happy with the results I am getting.
I chose a machine in that middle range that has
variable spot sizes available in order to speed
up the treatment process. Most of my treatments
are 10 minutes or less.


I am enjoying the cash business generated by the
use of lasers. I’ve done this long enough to see
very good results in my patients. Those waiting
on evidence-based medicine to verify what I am
seeing in my office may very well be missing a
lot of deposits into their bank accounts. Do you
want to be on the cutting edge of medical
technology or lagging way behind?


Scott Nelson, DPM, Garland, TX, xpoddoc@gmail.com


03/11/2013    David Zuckerman, DPM

Efficacy of Lasers for Onychomycosis (Adam Landsman, DPM)

It’s important to first acknowledge that any
type of laser treatment for fungus toenails is
not a miracle cure. We need to continue to
develop the research investigating laser
treatments in order to determine the exact
mechanisms of action, how we can improve
outcomes, what the biomechanical and structural
role of the foot is, and how it affects
outcomes, as well as to examine the systemic
implications of laser treatments, i.e., auto-
immune disease, diabetes, etc.


I was surprised that Dr. Landsman believes that
heat plays the primary role in destroying
fungus, especially given his research with the
laser company Normir in photo-inactivation along
with ROS mechanism. Heat very well may be one of
the mechanisms of action in the destruction of
fungus, but I have not seen any IN-VIVO studies
suggesting that heat is the only mechanism of
action. Perhaps, I misunderstood what Dr.
Landsman was implying, but it seems as though he
is suggesting that 80 degrees C, or 176 degrees
F, would be an effective temperature to use for
the laser nail treatment. At 176 degrees F,
though, you can say goodbye not only to the
toenail, but to the entire toe as well.


Additionally, I have never seen any written
evidence suggesting that wavelength determines
power. Wavelength determines penetration along
with other factors such as peak power. Without
the proper wavelength, you can have all the
power in the world but you must have penetration
along with peak power to achieve the proper
therapeutic dose.


Dr. Landsman also commented that diode lasers do
not have sufficient power. I cannot speak for
other laser companies, but we at Clearly
Beautiful Nail Solution have high-powered lasers
that go as high as 60 watts. The range is 10,
15, 30 and 60 watts. We have tested our lasers
demonstrating up to 25 centimeters of
penetration and, in some cases, more.


There have been multiple 1064, 980 lasers that
have undergone FDA clearance for fungus toenail
treatment with the submission of clinical
studies. However, FDA clearance only shows that
the company that submitted a study is similar or
predicated to another laser company that already
demonstrated a similar laser device. However,
none of the companies have submitted double-
blind, randomized, placebo-controlled and multi-
center studies to the FDA.


In conclusion, there is a lot of work to be done
in examining the effectiveness of laser
treatment of fungus toenails. I believe that
lasers make toenails look better than other
forms of treatment, which helps contribute to
the very high patient satisfaction. But laser
treatment for fungus toenails should be
considered and treated as a cosmetic procedure,
not a procedure that will consistently kill any
type of dermaphyte. While I do believe that heat
is a factor in the destruction of fungus, photo-
inactivation and bio-stimulation are equally
important mechanisms of action.


As Dr. Landsman alluded to, proper technique is
important. Many doctors get varying results,
even when using the same lasers. Nail selection
might be a factor. It’s also possible that we
are forgetting to educate patients about the
goals and limitations of laser treatments. But
in any case, it is of vital importance that we
continue to conduct more studies.


David Zuckerman, DPM,
CEO Clearly Beautiful Laser Solution
Cherry Hill, NJ,
footcare@comcast.net


03/09/2013    Adam Landsman, DPM, PhD

Efficacy of Lasers for Onychomycosis (Tip Sullivan, DPM)

I would like to respond to Drs. Katzen and
Sullivan regarding their impressions on laser
therapy for onychomycosis. I was disturbed by
Dr. Sullivan's description of his tests of the
laser for the treatment of onychomycosis. In my
opinion, this type of anecdotal observation is
really misleading for a variety of reasons.
Among my strongest concerns are the following:


-There is no doubt that fungus and bacteria are
heat labile. Apply enough heat and they die.
This is very strongly supported in the
literature. The question is how much heat did
you apply? Several factors have to be
considered. Some devices raise the tissue
temperature to 42C, while other devices can
reach 80C. This is strongly dependent on the
waveform used to deliver the energy.


Each machine uses a different, proprietary
waveform, and this has a direct impact on the
temperature achieved. Similarly, the inexpensive
diode lasers lack the energy necessary to
generate enough heat. All 1064 lasers are not
created equally. Only one 1064 device has
actually gone through the process of submitting
clinical data to the FDA. All the rest have a
510K clearance, and we really don't know how or
if they work.


-Spot size is also critical. Larger spot sizes
are usually detrimental to the antifungal
process due to a degradation in temperature from
the center of the laser beam to the perimeter.
Larger spot size means greater loss of
temperature. This is why the FDA clearly
specified a 1.5mm spot size.


-Number of pulses must also be monitored. We
recently participated in a study in which 4
sites were utilized. One of the 4 sites used 50%
fewer pulses, and their outcomes were dismal,
while the other sites did extremely well.


-Remember that the gold standard is the oral
medication, and the success rate for "total
cure" (i.e. negative mycology, and at least 5 mm
of clear nail) ranges from 39-59%. When I first
began to prescribe oral anti-fungals, they were
also not covered by insurance, and we saw about
50% success. Our patients new up front what
their chances were and made an informed
decision.


In conclusion, these "simple" studies are just
that. They give very little information of
value, and tend to attract harsh critics who
have not had the results they hoped for, for a
variety of reasons. Like with everything in
medicine, proper technique always matters.


Disclosure: I am an advisor to PinPointe and
conducted clinical studies on behalf of both
Pinpointe and Nomir.


Adam Landsman, DPM, PhD, Cambridge,
MA,alandsman@challiance.org

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