The Food and Drug Administration has approved an injectable filler to correct facial fat loss in people with human immunodeficiency virus (HIV) infection.
The filler, called Sculptra, is the first such treatment approved for a condition known as lipoatrophy, or facial wasting, a sinking of the cheeks, eyes and temples caused by the loss of fat tissue under the skin. Lipoatrophy is common among HIV patients. FDA expedited review of the product because of its importance to people with HIV/AIDS.
Sculptra was shown to produce significant increases in skin thickness, adding volume to facial tissue and restoring shape in areas of the face with fat loss. After an initial treatment series, repeat treatments may be needed to maintain the correction. Studies reported an improvement in the quality of life among those treated and less of the anxiety and depression often associated with lipoatrophy.
Sculptra is a synthetic polylactic acid that has been marketed under the trade name New-Fill in Europe. It has been used in more than 30 countries throughout the world for the treatment of facial volume imperfections, wrinkles and folds. Possible side effects of Sculptra are redness, bruising, lumping and granulomas.
"Change in facial appearance is one of the emotionally devastating and stigmatizing side effects of HIV/AIDS and the drugs used to treat it,” said FDA Acting Commissioner Dr. Lester M. Crawford. “The AIDS community has been awaiting a product like this that can give patients a smoother, fuller face.”
FDA approval of Sculptra was based on a review of clinical studies of safety and effectiveness submitted by the manufacturer, Dermik Laboratories, of Berwyn, Pa.
Dermik reported on the use of Sculptra in 278, HIV-positive patients with severe facial lipoatrophy. The patients, who were all being treated with antiretroviral drugs, were primarily white males, mostly ages 41 to 45. Patients were given three to six injections of Sculptra at two-week intervals and were followed for two years.