Sculptra is a proprietary formulation of poly-L-lactic acid (PLLA) that is an FDA-approved dermal filler manufactured by Dermik Pharmaceuticals, 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.
PLLA is injected into the skin in areas where fat has been lost. It causes the skin to thicken via collagen neo-synthesis, improves appearance of folds and sunken areas, and hides the fat loss. For most people who participated in PLLA clinical studies, the effects of treatment lasted for two years.
Side effects of Sculptra injections included the delayed appearance of small bumps under the skin in the treated area. Other side effects included bleeding, tenderness or discomfort, redness, bruising, or swelling.
PLLA is primarily used by dermatologists as a volume filler for lipoatrophy of cheeks in thin fit women or men who have lost facial fat. It has been called a "liquid facelift" because adding volume to the malar and cheek areas lifts sagging areas of the atrophic face.
- US FDA. "Sculptra Aesthetic Label". http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030050c.pdf.
- US FDA. "Medical Device User Fee and Modernization Act (MDUFMA) 2005". Retrieved 12 August 2013.
- US FDA. "Sculptra Aesthetic Modified Label". Retrieved 12 August 2013.
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