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

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.