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.

Abstract
Background: Since the approval of Sculptra Aesthetic, the amount of sterile water used to reconstitute the product has gradually increased in clinical practice. A retrospective chart review was conducted to evaluate patient safety associated with a larger reconstitution volume, and to investigate specific parameters for how Sculptra Aesthetic is used in a real-world clinical setting.
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. 2021;20(1):18-22. doi:10.36849/JDD.2021.5631

INTRODUCTION

Sculptra Aesthetic is a poly-L-lactic acid (PLLA) containing injectable implant, used for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles, in which deep dermal grid pattern (cross-hatch) injection technique is appropriate.1 Sculptra Aesthetic provides gradual improvement in skin thickness and appearance over several months, as measured by wrinkle assessment score and aesthetic improvement.2-4 Results are long-lasting with high levels (≥80%) of patient satisfaction5 and investigator-assessed improvement6 reported 25 months post-treatment.The original approval for Sculptra for treatment of lipoatrophy in HIV patients, which was obtained in 2004, covered a reconstitution volume of 3–4 mL. A following pivotal study on aesthetic use of the product, presenting a standardized protocol for reconstitution, resulted in the approval of Sculptra Aesthetic in 2009, including an increase in reconstitution volume to 5 mL.4 In clinical practice, the amount of sterile water used to reconstitute Sculptra Aesthetic has gradually increased further, often in combination with adding anesthetics to the solution,7-9 and consensus recommendations for EU10 and US11 have been established, promoting final injection volumes of 9 mL, including anesthetics for facial injections. The aim of this retrospective chart review was to evaluate the safety of Sculptra Aesthetic in a clinical setting when using a reconstitution volume of 7–10 mL, via collection of adverse events related to the product or injection procedure reported in medical records.

METHODS

Participating US sites had medical records of ≥50 subjects treated with Sculptra Aesthetic reconstituted to 7–10 mL in any facial