Effectiveness and Safety of Sculptra Poly-L-Lactic Acid Injectable Implant in the Correction of Cheek Wrinkles
January 2024 | Volume 23 | Issue 1 | 1297 | Copyright © January 2024
Published online December 15, 2023
Sabrina Fabi MD FAAD FAACSa, Tiffani Hamilton MDb, Brenda LaTowsky MDc, Rebecca Kazin MDd, Keith Marcus MDe,f, Flor Mayoral MDg, John Joseph MDh, Deirdre Hooper MDi, Sachin Shridharani MDj,k, Jessica Hicks PhDl, Daniel Brasater PhDm, Felipe Weinberg MDm, Inna Prygova MDm
aCosmetic Laser Dermatology, San Diego, CA
bHamilton Research, LLC, Alpharetta, GA
cInvestigate MD, Scottsdale, AZ
dRKMD, Rockville, MD
eMarcus Medical Spa, Redondo Beach, CA
fMarcus Facial Plastic Surgery, Redondo Beach, CA
gMayoral Dermatology, Coral Gables, FL
hClinical Testing of Beverly Hills, Encino, CA
iAudubon Dermatology/DelRicht Research, New Orleans, LA
jLUXURGERY, New York, NY
kWashington University - St. Louis School of Medicine, Division of Plastic and Reconstructive Surgery, St. Louis, MO
lGalderma Laboratories, L.P. Dallas, TX
mGalderma, Uppsala, Sweden
Abstract
Background: The current study evaluated the effectiveness and safety of Sculptra injectable poly-L-lactic acid (PLLA-SCA) treatment in correcting cheek wrinkles compared with a no-treatment control.
Methods: Male/female immune-competent adults (aged >21 years) with moderate/severe cheek wrinkles, graded using the Galderma Cheek Wrinkle Scale (GCWS) at rest, were randomized 2:1 to receive PLLA-SCA injections (150 mg; 8 mL reconstitution in sterile water for injection) + 1 mL lidocaine hydrochloride (2%), administered immediately after reconstitution, or no treatment (control). Up to 3 additional treatments were allowed at monthly intervals, and follow-up was at months 7, 9, and 12. The primary endpoint was 1-grade or greater improvement in GCWS at rest for both cheeks at month 12.
Results: GCWS at rest responder rate was significantly higher with PLLA-SCA treatment versus the no-treatment control at months 7 (66.2% versus 38.6%; P=0.0043), 9 (70.6% versus 31.1%; P<0.0001), and 12 (71.6% versus 26.1%; P<0.0001). Treating investigators reported improvements in skin radiance (>95%), tighter appearance (>88%), and jawline contour (>85%). PLLA-SCA recipients reported high satisfaction levels regarding improvements in skin radiance (90% or greater), sagging (84% or greater), and firmness (91% or greater) as well as natural-looking results (85% or greater) and a desire for repeat treatment (84% or greater). Treatment-related adverse events were mostly mild in severity with no serious events related to PLLA-SCA injections.
Conclusion: Injectable PLLA-SCA treatments were well tolerated and significantly reduced the severity of moderate/severe cheek lines and wrinkles, while improving skin quality. Effectiveness was durable over the 12-month study period with high subject-reported satisfaction, natural-looking appearance, and enthusiasm for repeat treatments.
ClinicalTrials.gov registry number: NCT04124692
J Drugs Dermatol. 2024;23(1):1297-1305. doi:10.36849/JDD.7729
INTRODUCTION
Sculptra poly-L-lactic acid injectable implant (PLLA-SCA; Galderma, Sweden) is a plant-derived alpha-hydroxy-acid polymer.1-4 When used for soft tissue augmentation, PLLA-SCA gradually stimulates collagen formation, over the course of several treatments, to provide semi-permanent correction of facial volume loss associated with aging.1-4
Injectable PLLA-SCA has demonstrated durable and natural looking results in randomized studies, with most recipients (80%) maintaining aesthetic correction of contour deficiencies until the 25-month data cut-off.5,6 Growing experience has driven an improved understanding of optimal PLLA-SCA injection techniques to achieve high levels of treatment satisfaction and good safety outcomes.2,7-9 PLLA-SCA studies
