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One Better than Botox. Wrinkles Get Double Dose
by Adding Treatment Called Restylane
This could be the beginning of a beautiful
friendship. Botox has nothing to fear from the
pending approval of a new wrinkle treatment. Rather
than try to muscle out Botox, the new product
on the scene, Restylane is likely to feed a desire
for a combination treatment that is better than
just Botox alone, cosmetic surgeons say.
"Botox and Restylane are really synergistic
because they're working on different parts of
the same problem," says Richard Glogau, a
dermatologist in San Francisco. Botox paralyzes
muscles so that skin tightens and emotion lines
disappear. But surface wrinkles often remain after
treatment where skin is creased from repeated
folding, especially for men, sunbathers, frequent
puckerers or people with especially animated facial
expressions. Injecting Restylane, a lab-produced
gel of hyaluronic acid – a water-binding
molecule found naturally in the skin – fill
sin those residual lines by boosting volume under
the skin. Collagen, a bovine byproduct, is currently
used to do this, but typically lasts four months
versus at least six months for Restylane.
Restylane, which has regulatory approval in 60
countries, is expected to win the FDA's blessing
as early as July, according to Q-Med AB, the Swedish
company that produces it. In a study to be presented
at an American Academy of Dermatology meeting
later this month, researchers found that using
Restylane with Botox to treat deep wrinkles between
the eyebrows leaves skin smoother than either
treatment alone and with longer-lasting results.
The study was funded by Q-Med.
"If you do one, it's half a treatment,"
says Jean Carruthers, an opthalmologist at the
University of British Columbia, who co-authored
the study with her dermatologist husband, Alastair.
"If you do both, you have a magical result."
The study treated 38 patients with moderate to
bad frown lines, or "glabellar lines,"
with either Restylane alone or Restylane with
Botox. The effects of using just Restylane wore
off after 18 weeks, compared with 32 weeks using
both. The Botox- Restylane combination appears
to work best to smooth the forehead, between the
eyebrows, "smoker's lines" above the
lip, and the liens that extend from the corners
of the mouth to the chin, commonly called "droopy
mouths." Certain wrinkles are better tackled
with just one of the treatments, as indicated
in the adjacent chart.
The combination treatment isn't for the needle-shy
and can mean dozens of shots. To treat lines above
the lip requires about four shots of Botox and
half a dozen of Restylane, says Dr. Glogau, the
San Francisco dermatologist. Nor is it for the
faint of wallet: An average Restylane treatment
in Canada, where it is approved, costs about $600,
while an average Botox treatment in the U.S. is
close to $400. Initially, combination treatment
s are expected to run about $1,000. Insurance
generally doesn't cover cosmetic procedures. Together
or alone, the treatments aren't perfect fountains
of youth, however Botox has been criticized for
making people look expressionless and hollow.
Injected incorrectly, it also can create a lopsided
smile or a droopy eyelid. Allergic reaction is
possible with Restylane , although it is rare.
One participant in the combination study developed
painful raised bumps, swelling and discomfort
between her eyebrows.
Restylane may also not work as well without Botox
because repeated movement of muscles can beak
up the Restylane's molecules faster, leading to
shorter results. Some doctors also could overcompensate
for Botox's slower activation period, which is
five to seven days, with too much Restylane, which
activates immediately. Such an overcompensation
can result in a bumpy appearance.
But proponents of the combination treatment say
there is no risk of unflattering effects like
a lopsided smile if one wears out before the other,
although Botox typically lasts four months and
Restylane from six months to a year. "I don't
think there would be anything stranger than the
natural aging process," says James Wells,
president of the American Society of Plastic Surgeons.
Restylane is expected to grab a significant part
of – and expand – the nearly $50 million
annual cosmetic-collagen market and attract more
patients to plastic surgeons. Indeed, Restylane
is already used on the sly by many cosmetic surgeons
in the U.S., said people familiar with the industry.
Sine Botox was approved for cosmetic use last
April, sales have risen 60% to about $175 million
in 2002 from 2001, according to Allergan Inc.,
the Irvine, California maker. (Botox has been
approved to treat neck pain and muscle disorders.)
But others want to get in on the game. Inamed
Corp., Santa Barbara, California, maker of popular
collagen products Zyplast and Zyderm, sells a
Botox-type product, called Dysport, in Europe.
Clinical trials for FDA approval should be completed
this year, Inamed says. Dysport is 10% cheaper
than Allergan's product in the U.K. and that price
discount is likely to be about the same in the
U.S. Inamed is also seeking approval for its own
hyaluronic acid product, Hylaform. It is made
from rooster's combs and lasts from three to six
months.
Meanwhile, Elan Corp. of Ireland is seeking cosmetic
approval of Myobloc, which is already approved
for neck spasms. Clinical trials to support cosmetic-use
approval could be done by the summer and so far
has shown Myobloc takes effect faster but may
not last as long as Botox.
Best Shots:
Cosmetic surgeons say a combination of Botox and
Restylane can improve the outcome of certain treatments.
Other types of wrinkles, however, are best treated
with one or the other.
Where two treatments
are better than one:
- Glabellar, or frown lines between the brow:
five injections of Botox and three to four of
Restylane.
- "Smoker's lines" above the lip: four
of Botox, half a dozen of Restylane. Particularly
painful because skin is sensitive.
- "Droopy mouth," the lines from corner
of the mouth to chin: Botox must be injected in
the jaw muscle along chin so as not to paralyze
the mouth. One injection of Botox on each side
and then three of Restylane on either side.
When one treatment
works:
- Crow's feet: just Botox because skin there is
so delicate. Restylane might create a bumpy, beady
look.
- "Turkey goblet" around the neck: Botox
is good for erasing the first signs. Surgery is
required for more severe cases.
- Lips: just Restylane so as not to paralyze the
mouth.
- "Smile lines": just Restylane, as
Botox could create a lopsided smile or paralyze
the mouth.
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