Chart Review Presenting Safety of Injectable PLLA Used With Alternative Reconstitution Volume for Facial Treatments
January 2021 | Volume 20 | Issue 1 | Original Article | 118 | Copyright © January 2021
Published online December 17, 2020
Melanie Palm MD MBAa, Flor Mayoral MDb, Anil Rajani MDc, Mitchel P Goldman MDd, Sabrina Fabi MDd, Lisa Espinoza MDe, Bill Andriopoulos PhDf, Justin Harper MDg
aArt of Skin MD, Solana Beach CA
bMayoral Dermatology, Coral Gables, FL
cRajani Aesthetic Advancements, Portland OR
dCosmetic Laser Dermatology:AWest Dermatology Company,San Diego,CA
eLa Chele Medical Aesthetics, New Hope, PA
fGalderma Aesthetics, Uppsala, Sweden
gJuvly Aesthetics, Columbus, OH
*Previously presented at the American Academy of Dermatology (AAD), Denver, Colorado, 2020, and at the Aesthetic and Anti-aging Medicine World Congress (AMWC), 2020.
Objective: The primary objective of the study was to evaluate the safety of Sculptra Aesthetic when using a reconstitution volume of 7 to 10 mL, via collection of adverse events related to the product or injection procedure reported in medical records.
Methods: This was a multi-center, retrospective chart review conducted in the US. Medical records for subjects treated in the facial area with Sculptra Aesthetic reconstituted to 7–10 mL were reviewed to obtain information about demographics, treatment data, and adverse events. Each injector completed a questionnaire regarding reconstitution and injection procedures generally used.
Results: There were 4483 treatments performed in 1002 subjects; nearly half (48%) had 3 or 4 treatments during the studied period. Subjects most commonly received treatment in the midface/cheek area (97%), temple (94%), and jawline (54%). All injectors indicated adding lidocaine to the solution, resulting in total volumes of 8–10 mL. Adverse events were reported by 3.6% of subjects, all mild in intensity. Nodules were reported by 4 subjects (0.4%).
Conclusion: The low number of AEs reported in this retrospective chart review suggests that facial aesthetic treatment with PLLA reconstituted to a final volume of 8–10 mL, including anesthetics, is associated with a favorable risk benefit ratio.
J Drugs Dermatol. 20(1):18-22. doi:10.36849/JDD.2021.5631