PLLA-SCA Approved for Correction of Fine Lines and Cheek Wrinkles

The US Food and Drug Administration (FDA) recently announced approval of Sculptra, an injectable poly-L-lactic acid (PLLA-SCA), for the correction of fine lines and wrinkles in cheek areas.¹

PLLA-SCA is an injectable collagen stimulator containing microparticles of PLLA that is known to gradually revitalizes the skin's structural foundation by smoothing wrinkles and significantly improving skin quality.

The approval was granted following a randomized, controlled, multicentered, double-blind study on PLLA. About 40 women were enrolled in the study where they received 3 treatments every 4 weeks with either PLLA injections for the treatment group or saline injections for the control group.² These were injected into both sides of the face. Following assessment, around the 12-month follow-up point, there was a ssignificant increase of skin elasticity and hydration in subjects treated with PLLA and a decrease in transepidermal water loss within both groups. Additionally, although radiance and smoothness were increased at 12 months, pigmentation, erythema, and pore size were decreased. Within the study, PLLA-SCA achieved its primary efficacy end point of greater or equal to 1-grade improvement in cheek wrinkles at rest. Its secondary end point regarding cheek wrinkles when smiling was achieved up to 2 years.

PLLA-SCA should not be used by patients who have a history of keloid formation or hypertrophic scarring. Additionally, safety has not yet been established in patients who are pregnant, lactating, breastfeeding, or under age 18 years. Common adverse reactions include injection site swelling, tenderness, redness, pain, bruising, bleeding, itching and lumps; additionally, small lumps under the skin are sometimes noticeable when pressing on the treated area. Larger lumps may occur, with some having a delayed onset with or without inflammation or skin discoloration.

References

1.  Galderma receives FDA approval for Sculptra for cheek wrinkles. News release. Galderma. April 26, 2023. Accessed May 1, 2023. https://www.prnewswire.com/news-releases/galderma-receives-fda-approval-for-sculptra-for-cheek-wrinkles-301807665.html

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