In the News:

Sculptra skin-firmer replacing the scalpel
By Susan Miller
Palm Beach Post Staff Writer

Wednesday, September 21, 2005

A product developed to treat facial wasting in HIV patients is gaining popularity among plastic and cosmetic surgeons who are using it to get rid of laugh lines, sunken jowls and those tiny crow's-feet that come with age.

And if early test results of the product, known as Sculptra, are any indiction of its potential, folks from Boca Raton to Beverly Hills likely will be banging down doctors' doors to get poked like pin cushions in the name of beauty.

Unlike collagen and other filler products which last only a few months, early tests show that Sculptra's effects last at least two years. That's because the main component, poly-L-lactic acid, stimulates the growth of a patient's own collagen. Poly-L-lactic acid has been used for more than 20 years as a component of dissolvable stitches. It's also been marketed in Europe under the name New-Fill, and has been used on more than 150,000 people in more than 30 countries for cosmetic purposes.

Sculptra is injected just below the skin's surface, filling in sunken cheeks and making for a more youthful appearance. It's not just one or two injections, but perhaps 15 to 20 tiny pinpricks containing small amounts of the product that are required in each area needing improvement. The area is first numbed and patients liken any discomfort to a mosquito bite or eyebrow tweezing.

Elona Horwitz, 48, and her mother, Audrey Flaks, 74, both of Boca Raton, wanted to look younger without having to undergo something as drastic as plastic surgery, but also wanted something that would last longer than other products.

"My mother had lines that bothered her and she would never consider doing surgery. This was an alternative," Horwitz said. "She looks fabulous after just one treatment."

It usually takes two to three treatments for the full effect, and the cost is around $3,000 total. By comparison, other fillers cost about the same, but last only four to six months. Surgical face-lifts can cost $15,000 to $30,000, depending on the extent of the surgery and the doctor doing it.

Of the estimated 9.2 million cosmetic surgery procedures performed last year, doctors are seeing a dramatic increase in the number of patients opting for less invasive ways to restore their looks. In 2004, there was a 47 percent increase in the number of soft-tissue filler procedures compared with 2003, according to the American Society of Plastic Surgeons. Those include Restylane, collagen and fat injections.

"The advantage of Sculptra is that you don't have to harvest it like fat; it's a faster process and less expensive," said Dr. Lawrence Reed, a board-certified plastic surgeon in New York and spokesperson for the American Society for Aesthetic Plastic Surgery. Reed has used Sculptra on his patients for almost a year with positive results.

"I saw a lady today who I did a while ago and she looked incredible," Reed said.

Horwitz and her mother had their first Sculptra injections at the Dermatology and Aesthetic Center in Boca Raton, one of 10 sites across the nation that has been testing the product for the past two years. Though Sculptra received FDA approval last August for use in HIV patients, it is being used "off label" to treat the effects of aging.

Dr. Marta Rendon, a board-certified dermatologist at the Boca Raton practice, not only has used the product on more than 100 of her own patients, but also is training doctors to use it.

"We have discovered that when you replace lost volume (in the face) a person looks younger," said Rendon, who also is president of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "We have had excellent results."

The clinical trials are expected to be completed by the end of the year and the product's maker, Sanofi-Aventis, hopes to submit its results to the FDA by the middle of next year, according to a company spokesperson.

Dr. Michael Aruta, a Fort Lauderdale cosmetic surgeon, has only used the product on those with HIV, but he wants to start using it on patients who simply want to look younger.

"Medicines that keep (HIV) patients alive have facial wasting as a side effect. We are able to help them appear and feel better," said Aruta, who is being trained by Rendon.

"Eugene," a 42-year-old who didn't want his real name used, joined Aruta at Rendon's office, because the drugs he has been taking since being diagnosed with HIV in 1987 have made his cheeks look sunken.

"I am doing this to take back part of my looks. It's helpful to feel better about yourself," he said.

Dr. Rod Rohrich, chairman of the department of plastic surgery at Southwestern Medical Center in Dallas and immediate past president of the American Society of Plastic Surgeons, also has been participating in the clinical trials.

"The results are much like the initial Sculptra studies for HIV patients. They were quite amazing and sustainable," Rohrich said. "The main thing is that if injected properly, there are minimal side effects."

Those side effects include bruising, some swelling, and if not injected properly, small bumps, not visible to the eye, but palpable.

The results are more subtle than the stretched look of a face-lift and many patients like it for that very reason. "It's a subtle difference and that's what I love," Horwitz said. "It's not a false-looking pull; it's a natural look which appeals to me and my friends."