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

Blinded evaluator-assessed GCWS responder rates (at rest and dynamic) were significantly greater in the PLLA-SCA group compared with controls throughout the study period. These data build upon the effectiveness outcomes previously reported concerning PLLA-SCA injections and provide an indication of the treatment outcomes that clinicians may expect to see in their clinics.16,17 GAIS scores were high from month 1 (4 weeks after treatment 1) and endured for most PLLA-SCA recipients (>96%) through month 12. Again, this magnitude of treatment effectiveness as well as durability of treatment outcomes corresponds with the data reported for the adapted PLLA-SCA reconstitution protocol in nasolabial fold studies.16,17 Treating investigators considered skin quality parameters, skin radiance, and firmness (tightness), to be increased following PLLA-SCA treatment with improved jawline contour. These outcomes were corroborated by subject self-assessment data reporting improvements in skin quality (skin radiance, sagging, and firmness) following PLLA-SCA treatment (greater than or equal to 84%) and also mirrored published data demonstrating statistically significant increases in skin elasticity, radiance, and smoothness among individuals receiving repeated PLLA-SCA injections, compared with saline injections.11

Subjects recovered rapidly after each treatment, feeling confident enough to return to social engagement after approximately 4-7 hours. Treatment satisfaction was high throughout the study with PLLA-SCA recipients self-reporting natural looking results, younger looking and refreshed appearance, and improved self-confidence. Most (greater than or equal to 84%) said that they would choose to receive PLLA-SCA treatment again and would recommend it to others. Longer study periods may be of benefit for future investigations exploring cheek wrinkle improvement with PLLA-SCA treatments as nasolabial fold studies have demonstrated effectiveness, safety, and treatment satisfaction at 25 months, following the last treatment.6

PLLA-SCA injections were generally well tolerated with mainly mild treatment-related AEs, typically occurring at the injection site. The incidence of injection site nodule and papule formation was lower compared with previous trials examining PLLA-SCA and other dermatological fillers, potentially due to the increased reconstitution volume used in the current study.6,16,17 Other investigations examining higher administration volumes showed comparable incidences of treatment-related AEs.6,16,17 Improved safety outcomes may also be associated with enhanced administration techniques, informed by advances in the understanding of the anatomy of aging and the availability of expert recommendations and consensus.3,8,13-15 

CONCLUSION

Injectable PLLA-SCA treatments, administered using an immediate injection protocol, were well tolerated and provided significant reductions in the severity of moderate or severe cheek wrinkles. Durable effectiveness and improvements in skin radiance, firmness (tightness), and jawline contouring were observed over the 12-month study period. PLLA-SCA recipients reported high satisfaction and natural looking appearance and most expressed a desire to have repeat PLLA-SCA treatments.

DISCLOSURES

Sabrina Fabi is an investigator and consultant for Galderma, Merz, Revance and Allergan. Tiffani Hamilton is an investigator for Galderma. Brenda LaTowsky is an investigator for Galderma. Rebecca Kazin is an investigator and trainer for Galderma. Keith Marcus is an investigator for Galderma, a speaker for Galderma, Allergan, and Evolus, a trainer for Galderma, and Merz, and an advisory board member for Galderma, Allergan, Merz, and Evolus. Flor Mayoral is an investigator for Galderma. John Joseph is an investigator and paid speaker for Galderma. Deirdre Hooper is an investigator, speaker, and trainer for Galderma, investigator consultant and trainer for Allergan, an advisory board member for Evolus, and a consultant for Revance. Sachin Shridharani is an investigator for Galderma, Merz, Revance, and Allergan. Jessica Hicks, Daniel Brasater, Felipe Weinberg, and Inna Prygova are employed at Galderma.

Funding: This study was funded by Galderma R&D, LLC.

Selected data from the current study have been presented in the form of abstracts/posters at the following congresses: American Society for Dermatologic Surgery Annual Meeting, Denver CO, USA, 6-10 Oct 2022; Fall Clinical Dermatology Congress, Wynn Las Vegas, NV, USA, 20-23 Oct 2022; Maui Derm, Maui, Hawaii, USA, 23-27 Jan 2023; International Master Course on Aging Science, Paris, France 26-28 Jan 2023; AMWC North America, Miami, FL, USA, 23-25 Feb 2023, Annual Meeting of the American Academy of Dermatology, New Orleans, LA, USA, 17-21 Mar 2023; Aesthetic & Anti-aging Medicine World Congress, Monte Carlo, Monaco, 30 Mar-1 Apr 2023.

ACKNOWLEDGMENT

The authors thank Benjamin Bassichis, Z. Paul Lorenc, Melissa Chiang, and Michael Somenek for their contributions as principal investigators in the study.

Medical writing support was provided by Rebecca Down at Copperfox Communications Limited and Zenith Healthcare Communications Limited, funded by Galderma.

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AUTHOR CORRESPONDENCE

Sabrina Fabi MD FAAD FAACS sfabi@clderm.com
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