Sculptra: A wider future in the US?

September 1, 2004

Miami - Sculptra (Aventis), an injectable poly-L-lactic acid that tricks the body into producing collagen, fills a unique niche, says Peter Engelhard, D.O.

"Most fillers are either very short-term or permanent. For long-lasting results that are safe, Sculptra fills the gap," he says.

Dr. Engelhard is one of very few U.S. doctors with extensive experience in the use of Sculptra (marketed overseas for general cosmetic use as "New-Fill"). An anesthesiologist by training, he built an internal medicine practice and began to treat HIV patients, many of whom suffer from the stigma of facial lipoatrophy.

U.S. marketing is under way through Dermik Laboratories, the U.S. dermatology arm of Aventis.

Dr. Engelhard says it will be a "big deal" when Sculptra is approved for general cosmetic use in the United States. When that happens, he forecasts similar uses - e.g., dense filling and tightening - for the filler in this country.

"In Europe it's used for reconstruction of the cheek fat pad and for filling deeper nasolabial folds," he says. But, he adds, "EU doctors are using it almost everywhere - tightening the neck and even the skin on the back of hands."

Sculptra's record is not unblemished, says San Antonio-based plastic surgeon Tolbert Wilkinson, M.D., F.A.C.S., a member of the Emerging Trends committee of the American Society for Aesthetic Plastic Surgery. "We are getting reports from Europe about a good number of people getting abscessed granulomas. Some are taking up to a year to develop.

"It's the fillers that are supposed to last longer that tend to cause the problems," he adds.

In addition to granulomas (abscessed and non-abscessed), other potential side effects include swelling, redness, bruising and lumpiness.

Treatment protocol As his caseload shifted from medicine to cosmetic dermatology, Dr. Engelhard gave up the former to focus on the latter. He now has treated nearly a thousand patients with Sculptra. About 90 percent of his caseload is HIV patients, with whom his procedure is to grade their facial lipoatrophy on a 1 to 5 scale. Severity determines the number of treatments.

He administers the filler at four- to six-week intervals, waiting a couple of months before the last treatment to see how well the polylactic crystals are inducing collagen formation. Patient response is fairly predictable.

"With HIV patients, I see 1 to 2 mm of collagen depth from each treatment," he notes.

After completing the regimen, he doesn't see the patient for a year or two, and sometimes longer. However, HIV patients, fearing a return of the spectral markings of their disease, may become psychologically addicted to treatment and request more frequent upkeep than is necessary, he says.

"Because Sculptra is a contouring agent for deeper defects, the method is a little different. You don't want to overfill. The idea is to get a little product in each area and watch to see how the tissue reacts and grows," he says.

As with other fillers, Dr. Engelhard warns dermatologists to be careful about applying in the periorbital area.

"You have to inject under the orbicularis muscle and in tiny amounts to avoid producing nodules that might be visible," he says.

Doctors should prepare the polylactic crystals in sterile water a full two hours before use; otherwise, needles tend to clog. To get a head start, doctors can prep the night before, because Sculptra has a three-day shelf life without refrigeration.