THURSDAY, Aug. 05, 2004 (HealthDayNews) --
The U.S. Food and Drug Administration has granted expedited approval to an injectable filler that compensates for facial fat loss in people infected with the AIDS virus.
The Dermik Laboratories product, called Sculptra, is the first such treatment for lipoatrophy -- a facial wasting condition characterized by sunken cheeks, eyes, and forehead. The synthetic polymer from the alpha-hydroxy-acid family has been used for years in dissolvable stitches, bone screws, and facial implants, the agency said in a statement.
Approval was granted after clinical trials on 277 HIV-positive patients, primarily white males ages 41 to 45. Participants were given three to six injections at two-week intervals, and were followed for two years. Side effects, mostly related to the injection itself, included skin nodules, redness, swelling, and bruising.
An estimated 150,000 to 350,000 people in the United States could benefit from the treatment, the FDA said. The agency cautioned that the product has not been approved for wider cosmetic use.
You can learn more about Sculptra from this FDA news release.
