The U.S. Food and Drug Administration (FDA) has approved Sculptra®, Galderma’s injectable poly-L-lactic acid (PLLA-SCA), to correct fine lines and wrinkles in the cheek area.
Sculptra is the first FDA-approved PLLA collagen stimulator that smooths wrinkles and improves the firmness and glow of the cheeks, with results lasting up to 2 years. It was first approved for aesthetic use in the U.S. in 2009 to correct nasolabial folds and other facial wrinkles.
According to studies conducted, patients showed sustained aesthetic improvement in cheek wrinkles, with 96% showing improvement at 3 months, 94% at 1 year, and 94% at 2 years. Researchers concluded that the primary endpoint of ≥1-grade improvement in cheek wrinkles at rest was achieved. The secondary endpoint of addressing cheek wrinkles when smiling for up to 2 years was also reached.
The most common adverse events recorded were swelling at the injection site, tenderness, redness, pain, bruising, bleeding, itching, and lumps. Other adverse reactions included lumps under the skin, some with delayed onset with or without inflammation or skin discoloration. Galderma has however warned that PLLA-SCA should not be given to patients with a history of keloid formation or hypertrophic scarring.