Sculptra, Chinese: 舒顏萃, is a proprietary formulation of poly-L-lactic acid (PLLA) that is an FDA-approved dermal filler manufactured by Dermik Laboratories, which conducts the North American business of Aventis Dermatology, the global dermatology unit of Aventis (of Sanofi-Aventis).
PLLA was approved by the FDA on August 3, 2004, for the treatment of facial fat loss (also called facial lipoatrophy). According to documents from the US Food and Drug Administration, the FDA initially approved the drug on the basis of small studies conducted on HIV patients, specifically “for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus (HIV). Facial lipoatrophy is a condition in which people lose fat in their faces, especially in their cheeks and around their eyes and temples. People with HIV who take anti-HIV drugs may develop lipoatrophy. Sculptra was subsequently approved by the FDA for use with non-HIV patients with wrinkles, despite substantial complications reported to the FDA.
After the injection, it will take around 1 to 1.5 months to grow natural collagen gradually. Right after the injection one's face may experience swelling and bruise, but after few days, the swelling will go down and the water will be absorbed. After the injection, patients must carries out a massage process in order to ensure that the injectable solution is smooth, level and evenly distributed inside the skin.
- US FDA. "Sculptra Aesthetic Label". http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030050c.pdf. External link in
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- US FDA. "Medical Device User Fee and Modernization Act (MDUFMA) 2005". Retrieved 12 August 2013.
- US FDA. "Sculptra Aesthetic Modified Label" (PDF). Retrieved 12 August 2013.