MONDAY, Dec. 15, 2003 (HealthDayNews) -- A new wrinkle smoother has won approval from the U.S. Food and Drug Administration.
The treatment, an injectable gel called Restylane, has long been used in Europe and is the third injectable wrinkle treatment to win FDA approval, the Associated Press reports.
The other two are Botox and Collegen. 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.
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. Most of the patients studied were Caucasian.
Restylane manufacturer Q-Med AB of Sweden has agreed to do more research on whether the treatment will cause any pigment alternations if used by non-Caucasians, although FDA said widespread use in other countries hasn't raised concern.
For more information, see this FDA Talk Paper.
