What Sculptra’s New Approval Means for Your Next Appointment


The FDA recently approved a new label for Galderma’s popular injectable Sculptra. The increased availability of the collagen biostimulator is a game-changer, experts say. By a statement, the new label includes “higher dilution, addition of immediate use reconstitution, new injection techniques and optional addition of lidocaine.” These changes expand the options for professionals administering the injectable.

Sculptra is made with poly-L-lactic acid, which boosts collagen in the skin to treat and correct facial wrinkles and folds. According to the statement, studies have found that “treatment immediately after reconstitution with a higher reconstitution volume (9 mL, including lidocaine) was well tolerated, caused less pain, and was comparable to the reference group ( Sculptra 5 mL) in reducing the severity of nasolabial fold wrinkles (NLF) at week 48.”

“Sculptra has always been an outstanding product for boosting a patient’s natural collagen for volume and improving skin quality and texture,” says San Francisco, Calif. Facial Plastic Surgeon David W. Kim. “[I am] enthusiastic about this new indication for immediate use after reconstitution.

Diane Gomez-Thinnes, head of Galderma US, said the new label will allow the company “to improve the overall injector and patient experience.” According to the statement, Sculptra provides gradual, natural-looking results over approximately three treatments three weeks apart. The statement cites a study that found 100% of patients showed improvement in the appearance of wrinkles up to two years after their last treatment.

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