Washington — Doctors should anticipate a high learning curve as they begin to treat patients with the injectable filler Sculptra (Dermik Laboratories, Berwyn, Pa.), once known as New-Fill, expected to be made commercially available this month for treating facial lipoatrophy associated with human immunodeficiency virus (HIV).
In the three years prior to the filler's Aug. 3 approval by the U.S. Food and Drug Administration (FDA), Cheryl Burgess, M.D., F.A.A.D., Center for Dermatology and Dermatologic Surg-ery, has injected more than 1,300 vials of Sculptra in lipoatrophy patients, almost all of the cases HIV-related. But Sculptra is not a typical filler, and lipoatrophy patients do not require the typical cosmetic assessment, she says.
"There is a high learning curve when working with Sculptra," says Dr. Burgess. "In other words, it is not the easiest filler substance to inject for dermal enhancement." FDA OK eases processBefore Sculptra (poly-L-lactic acid/PLA) was approved by the FDA, Dr. Burgess couldn't supply it to her patients. Instead, her patients had the right, as sufferers of a terminal illness, to purchase it through a buyer's club that imports drugs and treatments approved for use in other countries.
Sculptra comes in a dry powder lyophilizate, and must be diluted with a bacteriostatic water and allowed to sit for at least 60 to 90 minutes — or, preferably, overnight — to allow the covalent bonding of the lactide monomers.
Dr. Burgess first lipoatrophy patient is shown before his first treatment with Sculptra three years ago (top left), and after the second treatment (top right), third treatment (bottom left), and two-and-a-half years post-treatment (bottom right). Photos: Cheryl Burgess, M.D., F.A.A.D.
"If the preparation is improperly mixed, the particulate PLA can clog the needle, making it difficult to administer the hydrogel," she says. "As a result, the viscosity of Sculptra was unlike any other filler substance I had worked with."
Now, with the filler's approval, Dr. Burgess can obtain Sculptra and pre-mix the preparation overnight, giving her better control over the mixture. But doctors who haven't yet worked with Sculptra can expect a similar experience until they acquaint themselves with the filler's properties, she says.
Goal differsAlso subject to a learning curve is the end result. The reconstructive nature of treating lipoatrophy differs from cosmetic endeavors, says Dr. Burgess. "Larger volumes are used to enhance the person to their chronological age, versus using smaller volumes for rhytids. This patient population is more concerned about appearing normal than trying to appear younger," she says.
Dr. Burgess first determines the patient's facial structure and the volume necessary to treat the concavities. She often has the patient bring in a pre-lipoatrophy photograph to help calculate the volume of substance needed to restore the features. She then gauges the amount of filler needed so that it's delivered gradually over three treatment sessions. She says that, in her experience, even patients with severe concavity can often complete treatment in a few visits.
As for the dermal enhancement itself, Dr. Burgess warns, "You don't want to over-enhance with this product." Once injected, she explains, the hydrogel is slowly metabolized along with the respiratory excretion of carbon dioxide, leaving the crystals to stimulate collagen production in the tissue and subsequent dermal thickening.