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FDA approves another wrinkle filler

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Restylane has been available in Canada and Europe for more than four years.

Monday, December 15, 2003 Posted: 9:20 AM EST (1420 GMT)

WASHINGTON (AP) -- People hoping to smooth wrinkles around the nose and mouth now have another options -- a wrinkle filler called Restylane long used in Europe.

Restylane is the third injectable wrinkle treatment to win approval from the Food and Drug Administration, which gave the greenlight to the product Friday.

Botox temporarily paralyzes muscles beneath the skin to smooth frown lines between the eyes. Collagen is used to fill other wrinkles, including those Restylane can treat. Both wrinkle fillers last about six months, the FDA said.

"It's another option," FDA's Dr. Celia Witten said of Restylane. "They're both effective."

Restylane is made with hyaluronic acid, a substance normally found in the skin that helps keep it plump.
In studies, 138 patients had wrinkles on one side of the nose injected with Restylane and the other side with collagen. Both sides appeared comparable.

Side effects include a slight tendency toward increased bruising, swelling and pain with Restylane, in roughly 3 percent of patients. But the problems were mild and resolved in less than two weeks, Witten said.

Most of the patients studied were Caucasian. Maker Q-Med AB of Sweden has agreed to do more research on whether Restylane will cause any pigment alternations if used by non-Caucasians, although FDA said widespread use in other countries hasn't raised concern.

A Q-Med spokeswoman said shipments would begin within two months; the company refused to release a price.

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