Palomar starts to market new "at-home" laser treatment

Palomar has received FDA clearance for their latest product, a hand-held, battery-powered laser. It's called the "PaloVia", and is the first unit cleared by the FDA for home use.

The PaloVia uses a fractional method, in which only small "polka-dots" of skin are treated, and is non-ablative - meaning there won't be any raw, oozing areas after the treatment. It uses an established wavelength for treatment, 1410nm.

The company recommends daily treatment to the crow's feet area for one month, and then maintenance treatments twice weekly thereafter.

In their preliminary study, 92% of patients saw an improvement of one step on the Fitzpatrick wrinkle scale (FWS). The FWS is a nine point scale, so one step, while measureable, is a pretty mild change.

Palomar has been pretty secretive about the other parameters of the laser. Obviously, the power of this laser is much, much less than an office-based machine, so the depth of penetration of the laser beam will be less, tissue heating will be less, and so the total effect will be much less. It might be enough to treat the thin skin around the eyes, but probably not enough to treat other facial areas, where the skin is thicker. It will probably be a good addition to retin-A based skin care and Botox, but time will tell.

Nevertheless, the whole concept of "at-home" lasers is newsworthy. Palomar is marketing these through QVC, so you probably start seeing these on television soon.

(Image from PaloVia.com)

A new laser treatment for stretch marks? Maybe.

When patients come in with stretch marks, we've traditionally had little to offer them. Retin-A cream helps somewhat. IPL and vascular lasers can be used if the stretch marks are red or purple in color. But that was about it, unless the stretch marks were on the lower portion of the abdomen - and the patient wanted a tummy tuck, which would surgically remove the entire zone of stretch-mark laden skin.

Well, guess what. Just this month, Palomar Medical Technologies announced that their Lux1540 laser handpiece has received clearance by the FDA for the treatment of stretch marks. As you might expect, the company, their accountants and their stockholders are all very excited about this, as now they can market this laser to the millions of women worldwide who have unwanted stretch marks.

As we've discussed before, FDA approval for devices doesn't necessarily imply that the gadget is effective - just that it is reasonably safe. So does this laser really do what it claims?

The Lux 1540 isn't that new - it's a fractional, non-ablative "erbium-glass" laser that's been previously used for skin resurfacing and the treatment of scars. What's new here is the official indication for use in stretch mark therapy. According to the data submitted to the FDA, clinical studies with the Lux1540 achieved an average improvement of between 51% and 75% in the appearance of stretch marks, over a three month time period. Of course, that's corporate-sponsored research. I haven't seen any peer-reviewed, independent studies as yet.

So, the stretch marks got better with the treatment, but did not vanish. Nevertheless, this could represent an improvement over the previous non-surgical therapies we've had for striae....we'll have to see how it pans out in independent trials.

Bottom line: cautiously optimistic.