(Sorry for the poor appearance of this message. I pasted it in from
an external editor, and I just cannot format it the line breaks
properly on this system. I will type future messages directly.)
Jack, you wrote:
>"With Laser Industries receiving the FDA green light to market their
>EpiTouch, it is important to keep in mind what makes the Palomar
> EpiLase a unique device and how it differs from the competition.
I believe that what is most important is how well Epilaser works.
After brief comparisons of Palomar's Epilaser and Thermolase's
SoftLight, you offered the following differentiating comments:
>The problem is, to my knowledge
>there are no peer reviewed studies that substantiate this method
>[Thermolase] of photomechanical destruction as a sound method of
>permanent hair removal >(an is why the Thermolase spas cannot claim
>permanent hair removal).
This is true, and Thermolase also cannot claim "long-term" or "painless"
hair-removal, as reported in an article in the Dow Jones News, 26 Apr 95,
and substantiated by FDA.
>Palomar has
>the clinical advantage of pointing to studies such as the one recently
>publised in a leading dermatology journal that substantiates ruby
>laser hair removal.
It cannot be all that much of an advantage, because according to
Mr. Richard Felton, of the U.S. FDA, Palomar's Epilaser 510-k
clearance does not allow any claims beyond what Thermolase is
allowed. I learned that when I spoke with him by phone at 9:30 AM
EST on 10 March 1997.
But let's have a look at some of the highlights of the peer-reviewed
article you cited. It was published in the Journal of The American
Academy of Dermatology, Volume 35, Number 6, pp. 889-894. It is
entitled "Damage to hair follicles by normal-mode ruby laser pulses", published by Melanie C. Grossman, MD. et al.
I was most interested in the human study, which consisted of "thirteen
healthy adult volunteers (12 men, 1 woman)", "recruited through
newspaper advertisements".
All had "fair skin", and "brown or black hair." That alludes to one of
the limitations of the ruby laser methods - dark skin absorbs too much
of the light, increasing skin damage and pain, while reducing the
effectiveness of the treatment. Also, very fair hair does not absorb
the laser energy very well.
Exclusion criteria included "photosensitivity, pregnancy, history of
keloid formation, immunosuppression, or a history of poor wound
healing." So it appears that there were some concerns about
treating persons with these conditions.
The treated areas were "chosen on the back or posterior thigh,
based on uniformity and density of terminal hair-follicles", consisting
of "eight 3 x 2 cm sites".
Here is how the subjects described their sensations of their exposures
to the irradiation of the test sites using the laser:
"Subjects described the exposures as moderately to strongly painful,
and a "rotten-egg" smell occurred with exposures."
So it sounds like the cooled hand-piece was not all that effective in
minimizing pain, and this is the first time I have ever heard of odour
problems.
As for results, the paper presents a graph showing the "pooled
percentage of hair regrowth at 1, 3 and 6 months, as a function of fluence
in epilated and shaved sites, for all subjects." It goes on to say, "A
statistically significant growth delay was seen at 1 and 3 months for all fluences", and "at 6 months, 5 of the 13 subjects had complete regrowth
of hair in the treated sites, and four still had less than 50 percent regrowth.
Of these four, two showed no regrowth between 3 and 6 months."
In other words, the results were not permanent, nor were they long-term!
In fact, looking at the bar-graph, at 3 months, the average regrowth was
about 58 percent, and at 6 months it was about 75 percent! I cannot
imagine very many persons paying thousands of dollars for such a
poor efficacy.
There is also this interesting comment, "We also expected to see more
of a relation between fluence and response with respect to hair regrowth.
owever, the hair regrowth data within and between subjects does not show
a significant fluence-response relation. The data in this study therefore
suggest a low damage threshold for induction of growth delay, and a
higher damage threshold for permanent hair loss."
The range of fluences used in the human trials was 30 to 60 J/cm^2,
and it is my understanding that the Epilaser can go up to 75 J/cm^2, so
from the above it appears that the Epilaser does not have much
likelihood of producing anything better than about a 58 percent regrowth
after three months, in the large majority of persons.
The inference that finding a higher follicle-damage fluence threshold
might produce permanent hair-loss may be moot, because of concerns
about skin damage and pain. Keep in mind that the human subjects
reported a "moderate to strongly painful" response to the 30 - 60
J/cm^2 fluence range.
>The cosmetic surgery market is a volatile one, but alternatives to
>electrolysis and waxing interest the paying public and are already
>being sought.
True, but only if they are provably superior, in terms of cost/benefit
and risk/benefit. Smart investors and consumers of high-tech know that:
- almost anything can be claimed in a patent
- peer-reviewed scientific papers do not prove much (the discovery of
fossil bacteria in a Mars rock found in Antarctica was published in a
peer- reviewed journal, but that did not mean that there was proof that life
ever existed on Mars. There will be many such papers, pro and
con before the issue is settled, if ever)
- FDA 510-k clearance to market says almost nothing about effectiveness
Keeping the above in mind, I note that the U.S. patent underlying the
Epilaser, #5595568, has the title, "Permanent Hair Removal Using
Optical Pulses". But the peer-reviewed paper demonstrates only very temporary results, And the FDA prohibits claims of "permanent",
"long-term" or "painless" results.
Obviously those who like to tout their patents, peer-reviewed papers,
and FDA clearances, are hoping nobody bothers to read them.
>It strikes me that science is strongly behing Palomar and, for the mean
>time, so is my money."
Yeah, right.
Caveat Emptor!
Ted Molczan |
