You say you have not seen any evidence that laser hair removal will
never lend itself to permanent hair removal. I believe that I have seen
some evidence that the laser may have hit a brick wall, unless there is
a technological breakthrough.
First, consider that the Thermolase SoftLight, which delivers a
fluence of at most 2.5 J/cm^2, provides only a temporary reduction
in hair, with nearly complete regrowth within 3 to 6 months.
Second consider that Epilaser delivers 10 - 50 J/cm^2 fluence,
according to Palomar's 10KSB for F'96, filed on 11 Apr 97.
Third, consider that the limited Epilaser pre-cursor clinical trials at
MGH, between Sep'94 and Mar'95, used 30 - 60 J/cm^2 pulses,
and achieved substantially similar results to SoftLight - the 13 subjects
averaged 58 percent regrowth after 3 months, 75 percent at six months,
with 5 of 13 having 100 percent regrowth by that time. Also, subjects
reported "moderately to strongly painful" treatment.
This trial was written up in the Dec'96 Journal of the American
Academy of Dermatology. In their discussion the researchers said,
"We expected to see more of a relation between fluence and
response with respect to hair regrowth. However, 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
damge threshold for induction of growth delay and a higher damage
threshold for permanent hair loss." They did not suggest what that
higher threshold might be.
So they speculated that a higher fluence was required to achieve
permanent hair removal. But the patients already reported pain
at 30-60 J/cm^2, so how much higher can they go? Also, consider
the possibility of skin damage at higher fluences.
Fourth, consider Dr. Rox Anderson's (Epilaser inventor) open letter
to physicians dated Sep'96, in which he says, "The treatment fluence
should typically be below (e.g. 30-50% below) that causing acute
epidermal injury. Because of the range of skin pigmentation, treatment
fluence may range from about 10 J/cm^2 (in a dark skinned person),
to as high as 75 J/cm^2 (in a very fair sinned person)."
So Anderson placed a limit, at least for Epilaser, not much above that
of the 1994-95 13 subject trial, and even then, limited to the fairest skin.
Moreover, consider that fair skinned people also tend to have fair
hair, which would have too little melanin to readily absorb the laser
energy. The best results seem to be achived on brown or black hair,
but according to Anderson, the growth delay was only 2 to 6 months.
The Mar'97 MGH patient letter for hair-removal (issued after the FDA
clearance to market was granted) clearly indicates that 80 percent
of a 1000 test-site (100 subjects) trial had regrowth in 2 to 3 months.
Also, the pain appears to be fairly severe, because the topical
anesthetic, EMLA, is recommended, or alternatively a xylocaine
injection. Finally, 25 percent of subjects had darkened skin, that took
three months to fade. Presumably, these results were achived at the
noraml Epilaser fluence, up to 50 J/cm^2.
So it appears to me that the single treatment limit has been reached,
and the results are far from permanent, not even long-term.
The only other hope had been that multiple treatments would be
efefctive in promoting permanence, but appears not to have worked.
Consider that in Anderson's Sep'96 letter, he referred to 60 patients,
with 400 sites, who had apparently been followed for up to 6 months.
Also consider that 6 months have passed since that letter was written,
yet there is no official, credible word of results.Why?
Finally, consider that Dr. Smotrich himself seemed to close the door
to further improvements, when he told investors on 18 Mar 97, that
"FDA has absolutely refused to give any kind of length of time that
the hair will not grow back, and my opinion is they probably should
never, and will never."
So I believe that the evidence is beginning to pile up, suggesting that
permanent laser hair removal may never be realized. At the very least,
it seems a long way off.
Ted Molczan |
