FDA Gives the Green Light for Cheek Wrinkle Solution

The US Food and Drug Administration (FDA) has given clearance for injectable poly-L-lactic acid (PLLA-SCA; Sculptra) to correct the effects of aging in cheeks.¹ During clinical trials (NCT04124692), patients (n=110) showed significant improvement in the reduction of fine lines and wrinkles in 3 months (96%), 1 year (94%), and 2 years (94%). Each study participant was given 8ml of the PLLA-SCA. "The primary endpoint was reached, which was ≥1-grade improvement in cheek wrinkles at rest and its secondary endpoint of addressing cheek wrinkles when smiling for up to 2 years,” researchers explained.²

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Galderma said Sculptra is the first FDA-approved PLLA collagen stimulator that smooths wrinkles and improves firmness and glow in the cheek for up to 2 years. The injectable was first approved for aesthetic use in 2009 in the US for the correction of nasolabial folds and other facial wrinkles. In 2004, the injectable was approved for the restoration and correction of fat loss in HIV patients. PLLA-SCA is currently available in more than 40 countries.

“Sculptra is a foundational treatment that helps smooth wrinkles and offers the added benefit of improved skin quality—helping to firm sagging skin for a more radiant and glowing appearance. My patients will be extremely pleased that they can now receive Sculptra in the broader cheek region to support collagen growht and to make their skin look more refreshed and rejuvenated,” shared Sabrina Fabi, MD in a press release. Fabi is a double board-certified dermatologist and cosmetic surgeon in California and served as an investigator in the PLLA-SCA clinical trials for cheek wrinkles.

According to Sculptra’s website, common adverse effects to the injectable include injection site swelling, tenderness, redness, pain, bruising, bleeding, itching and lumps. Other effects reported include lumps under the skin, some with delayed onset with or without inflammation or skin discoloration. Galderma warned that PLLA-SCA should not be administered to patients with a history of keloid formation or hypertrophic scarring. Safety has not been established in patients who are pregnant, lactating, breastfeeding, or under 18 years of age.³

References

1. Galderma. Galderma receives FDA approval for SCULPTRA® for cheek wrinkles. PR Newswire: press release distribution, targeting, monitoring and marketing. https://www.prnewswire.com/news-releases/galderma-receives-fda-approval-for-sculptra-for-cheek-wrinkles-301807665.html. Published April 26, 2023. Accessed April 26, 2023.

2. Bohnert K, Dorizas A, Lorenc P, Sadick NS. Randomized, controlled, multicentered, double-blind investigation of injectable poly-L-lactic acid for improving skin quality. Dermatol Surg. 2019;45(5):718-724. doi:10.1097/DSS.0000000000001772

3. Youthful skin starts within. Sculptra Aesthetic. Accessed April 26, 2023. https://www.sculptrausa.com/.