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.
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.
