New fillers promising but concerns remain

October 1, 2006

National report - Promising new temporary fillers will give dermatologists creative new options for combinations, but for some, semi-permanent fillers won't be among them, as many remain highly skittish over unresolved problems and safety issues.

Prospects look good for the two new hyaluronic acid fillers, Juvederm, which received Food and Drug Administration (FDA) approval for facial wrinkles and folds this summer, and Q-Med's Perlane, a higher viscosity product that has undergone clinical trials and is expected to be released in the next year or two.

Juvederm, made by Allergan, appears to have good longevity and a low side-effects profile, but whether it will be able to claim a higher status than its stellar counterpart, Restylane, remains to be seen.

Dr. Schlessinger was involved in the clinical trials for Perlane, and says the product also looks very promising as a next-generation filler.

"Perlane has a more malleable feel to it and may last a little longer than Restylane," he says.

"The bruising also seems to be less of a problem and tenderness seems improved with that product," he says.

Hog heaven not so inviting?

The porcine collagen product Evolence, made by ColBar LifeScience, has seen a success in Europe, but Dr. Schlessinger notes experience has shown that American consumers - and doctors - often don't warm up to animal products.

"When you look at the acceptance of Hylaform, a rooster-derived product, versus Captique, a bacterially engineered product, Captique had a much easier time being accepted by doctors and patients," he says.

The product Isolagen, which uses the innovative process of harvesting a patient's own collagen-producing cells to treat scar tissue and wrinkles, may encounter even more apprehension from dermatologists due to concerns about the storage of the cells and the safety of tissue banks.

Furthermore, the concept may simply be overshadowed by the increased number of other safe and effective products that have come on the market in the many years it's been in development.

"Now we have several companies with outstanding filler substances, so the prospect of sending off your skin and waiting for the collagen to be cloned could be something that consumers may at this point find hard to swallow," Dr. Schlessinger tells Dermatology Times.

Semi-permanent red flags

Meanwhile, products that have generated a high amount of buzz - not only for application on their own, but in combination with temporary fillers - are the semi-permanent fillers Sculptra, a poly-L-lactic acid filler made by Dermik, and Artes Medical's Artefill, which is expected to soon receive FDA approval.

Reports of granulomas have raised red flags for both products, however, and the fact that Sculptra only has FDA approval for HIV-related lipoatrophy is also a concern, Dr Schlessinger says.

"One of the problems I see with this product is that since it was approved for HIV patients, it wasn't thoroughly tested in immuno-competent individuals, and there could be different reaction patterns that we don't know about," he says.

Some suggest the granulomas can be avoided with a perfected injection technique, but Arnold Klein, M.D., says he doesn't accept that argument.

"They say that there's a learning curve and when you're learning to inject early on, you're going to produce problems," says Dr. Klein, a professor of medicine and dermatology at the David Geffen School of Medicine at the University of California, Los Angeles.