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Cosmetic Use of Sculptra Now FDA Approved
Date:8/12/2009

Growing options for facial shaping and rejuvenation

(Vocus) August 12, 2009 -- Sculptra, a poly-L-lactic acid filler previously approved for loss of facial fat in HIV positive individuals, is now approved for cosmetic use, to add volume and fullness to facial features and contours. "Sculptra offers a very different approach to treating the aging face," says Coalition leader Ira D. Papel, M.D., Baltimore, MD. "This cosmetic injection can deliver more diffuse, regional improvement in the soft tissue folds of the face. The results from Sculptra® Aesthetic develop over a period of time, allowing for a natural progression to an improved and more youthful appearance."

Sculptra® Aesthetic generally requires a series of injections, at three or more week intervals, for up to four treatment sessions. In clinical trials patients were followed for 12 months after their series of injections. It is reported that treatment outcomes were maintained up to 25 months after the last treatment session. Short-term injection site reactions were bleeding, tenderness or pain/discomfort, redness, bruising, itching or swelling. Other adverse events reported during the 25-month trial included small bumps and lumps, some with a delayed onset and were mild or moderate in intensity. Most side effects resolved on their own.

"Clinical trials for Sculptra® Aesthetic treated the nasolabial folds - the lines from the nose to the mouth - the same area that is commonly treated with hyaluronic acid dermal fillers such as Juvederm or Restylane," says Coalition leader Brian Biesman, M.D., Nashville, TN. "But the results are very different. The outcomes from a Restylane injection are immediately visible, and treat the area specifically where the substance is placed. The Sculptra results appear over time and are somewhat more diffuse. Metaphorically it is the differ
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Cosmetic Use of Sculptra Now FDA Approved
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