A Randomized Study on PLLA Using Higher Dilution Volume and Immediate Use Following Reconstitution

July 2021 | Volume 20 | Issue 7 | Original Article | 760 | Copyright © July 2021


Published online June 23, 2021

Melanie Palm MD MBAa, Susan Weinkle MDb, Younghoon Cho MDc, Bredna LaTowsky MDd, Heidi Prather MDe

aArt of Skin MD, Solana Beach, CA
bSusan H Weinkle MD, Bradenton, FL
cIntegrated Aesthetics, Spring, TX
dInvestigate MD, Scottsdale, AZ
eWestlake Dermatology Clinical Research Center, Austin, TX

Abstract
Background: The reconstitution volume of a PLLA-containing injectable device has gradually increased in clinical practice, often in combination with adding lidocaine to the solution.
Objective: This study, SCRIPT (Sculptra Contemporary Reconstitution & Injection Procedure Trial) evaluated PLLA for correction of nasolabial folds after changes in reconstitution and injection procedures. Primary endpoint for effectiveness was change from baseline of nasolabial folds, assessed by blinded evaluation using a validated wrinkle assessment scale (WAS), at week 48.
Methods: Subjects were treated to optimal correction of nasolabial folds at a single treatment regimen consisting of ≤4 injection sessions, with PLLA reconstituted with 8 mL or 5 mL sterile water for injection (SWFI), randomized 2:1. The 8 mL product included an additional 1 mL 2%-lidocaine and was injected immediately following reconstitution. Assessments included wrinkle severity, aesthetic improvement and safety.
Results: A total of 80 subjects were included in the study. Most subjects were female (95%), mean age was 51.5 years. Primary endpoint was met and subjects from both study groups demonstrated high WAS responder rates (≥1-grade improvement from baseline) at week 24 (≥75%) and week 48 (≥67%). Aesthetic improvement was high (≥86%) throughout the study. Adverse events related to study product or injection procedure were mostly mild and transient.
Conclusion: PLLA reconstituted with 8 mL SWFI demonstrated a comparable treatment effect to that of the reference group in reducing wrinkle severity of nasolabial folds. Safety was not compromised using a higher reconstitution volume including lidocaine, injected immediately after reconstitution.

J Drugs Dermatol. 2021;20(7): 760-766.. doi:10.36849/JDD.6034

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INTRODUCTION

Sculptra Aesthetic is a poly-L-lactic acid (PLLA)-containing collagen biostimulator, indicated 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 The product provides gradual, natural-looking improvement in skin thickness and appearance, 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 improvement,6 reported 25 months post-treatment.

Sculptra Aesthetic is used in the form of a suspension, reconstituted from a dry powder by addition of sterile water for injection (SWFI). The original US approval for Sculptra from 2004, covered a reconstitution volume of 3–4 mL. A following pivotal study presenting a standardized protocol for reconstitution, resulted in approval of the increase in reconstitution volume to 5 mL,4 which is per current US label. However, in clinical practice, the amount used to reconstitute the product has gradually increased, often in combination with addition of lidocaine,7 and consensus recommendations for EU8 and US9 have been established, promoting final injection volumes of 9 mL including anesthetics for facial injections. In addition, physicochemical analyses of Sculptra Aesthetic have shown that proper shaking of the product after adding SWFI provides well-dispersed PLLA particles in a homogenous suspension, suitable for immediate injection with no standing time required.10 These methods with a larger reconstitution volume and immediate use following reconstitution have been developed primarily to enhance the safety for patients, but also to provide a more flexible reconstitution protocol for health care practitioners, minimizing unnecessary standing time. This study, SCRIPT (Sculptra Contemporary Reconstitution & Injection Procedure Trial), was conducted to further evaluate alternative reconstitution methods and injection procedures for Sculptra Aesthetic as a single treatment regimen for correction of nasolabial fold contour deficiencies.