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Wrinkle-Fighter Restylane Expected Soon

May 21, 2003 -- Botox may soon have a challenger in the battle against unwanted facial lines. A new wrinkle filler called Restylane is expected to become an extremely popular option for nonsurgical cosmetic treatments, provided it clears FDA approval later this year as anticipated.

"Restylane is going to revolutionize this industry in the same way Botox did," says Rhoda S. Narins, MD, president-elect of the American Society for Dermatologic Surgery, and one of the investigators involved in the Restylane clinical trial currently being reviewed by the government.

Indeed, there is already a buzz -- mostly positive -- about the consequences of having an injectible device such as Restylane in the arsenals of plastic surgeons and dermatologists. Many experts know about it because it has already been approved and used in a huge number of patients in dozens of places, including Canada, Europe, and Australia. So far, the injectible drug is known to have an excellent safety profile, to cause little, if any, allergic reaction, and to work for a satisfactory amount of time (about 6 to 9 months).

The length of time that a treatment works is an important consideration, says V. Leroy Young, MD, spokesman for the American Society for Aesthetic Plastic Surgery (ASAPS). "It's generally better in aesthetic surgery to have something that goes away or can be removed," he says, noting that if a patient is unhappy with the result of a treatment, then the problem is temporary. Also, with fashion trends always changing, it's reportedly better to have something that can go away on its own, without use of surgery. He uses the example of lip enhancements, which are popular today, but in the 1960s and 1970s, thinner lips were more in vogue.

Young discussed the implications of Restylane and other new treatments and devices at a "Hot Topics" Seminar held today at the ASAPS' 2003 Annual Meeting in Boston.

In the trial used for FDA review, Narins and other researchers compared the effects of Restylane (a natural substance called hyaluronic acid found in living cells) and collagen (a natural substance derived from purified cow protein) on removing wrinkles on the sides of the mouth (smile lines).

Investigators injected either Restylane or collagen into the faces of 134 people, with the doctors and patients both unaware which substance was being used. After a year, an analysis of the results indicated the following about Restylane: It was just as safe as collagen (which has been on the market for about 20 years), it lasted much longer than collagen (six to 12 months vs. four to five months), and less of it was required to get the same result.

The study was submitted to the FDA last year for approval, and a response from the agency is expected this summer. A summary of the findings will be published in the June 2003 issue of the Journal of Dermatologic Surgery.