Cosmetic use of Sculptra now FDA Approved

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 difference between placing a graft specifically and instantly where you want results, vs. spreading a shower of seeds and waiting as those seeds begin to grow.”

“The new additions, and very different injections technologies to treat facial aging or improve appearance require that consumers choose a very well-trained, experienced physician if they are considering injections,” says Coalition leader Mark Codner, M.D., of Atlanta, GA. “The message of ‘Doctor. Brand. Safety’ is something easy to remember and important to follow. Choose your doctor carefully, elect only FDA approved brands and ask specifically about the benefits and potential adverse events you may experience. Most of all, make sure your goals include preserving your safety as specifically as you wish to improve your appearance.”

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ABOUT SCULPTRA

http://www.sculptraaesthetic.com

Introducing Sculptra Aesthetic. Not an overnight miracle. Long lasting. Not a quick-fix. The first facial injectable that gives you subtle results over time. Replacing lost collagen. Giving you a more natural-looking appearance, without giving you away. A full treatment of Sculptra Aesthetic, an average of three injection sessions over a few months, can last up to two years.* So you have more time to see how sensational subtle can be. Welcome to the new age of anti-age.

Sculptra Aesthetic is a new type of facial injectable made from poly-L-lactic acid, which helps to replace lost collagen. It helps correct shallow to deep facial wrinkles, and folds,** that appear with aging by replacing lost collagen. The main ingredient is a biocompatible, biodegradable synthetic material that has been used by physicians for decades.

Learn how Sculptra Aesthetic is different in the way it works and listen to what one patient has to say about it.
*Individual results and treatment sessions may vary.
**Safety and effectiveness of Sculptra Aesthetic have not been evaluated in areas other than nasolabial wrinkles and folds in clinical trials.

Sculptra Aesthetic gradually replaces lost collagen

Collagen is a key structural component that keeps skin youthful looking and smooth. As you age, your body's collagen production decreases, and you may begin to see wrinkles. Sculptra Aesthetic works to correct shallow to deep facial wrinkles and folds,* as it replaces lost collagen, which can help provide a refined, more youthful looking appearance.
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Sculptra Aesthetic works to replace lost collagen in a series of treatments administered by a Sculptra trained physician. On average, three injection sessions are needed over a period of a few months. The number of injection sessions and the number of injections per session vary from person to person.

Sculptra Aesthetic works within the deep dermis

Within the deep dermis, your skin's structure is reinforced as Sculptra Aesthetic helps to replace lost collagen. This reinforced collagen structure provides a foundation that gradually restores the look of fullness of your shallow to deep facial wrinkles and folds* that has been depleted over time. The result? Sculptra Aesthetic is different because it gradually and subtly corrects these facial wrinkles. This can provide a refined, more youthful looking appearance that can last up to two years.**
*Safety and effectiveness of Sculptra Aesthetic have not been evaluated in areas other than nasolabial wrinkles and folds in clinical trials.
**Individual results and treatment sessions may vary.
***Based on pre-clinical evaluation in animals. Sculptra Aesthetic is thought to work in a similar process.

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