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

Area of Science:

• Dermatology
• Aesthetic Medicine
• Biomaterials Science

Background:

• Clinical practice has seen increased use of higher reconstitution volumes for poly-L-lactic acid (PLLA) injectables, often with added lidocaine.
• This trend necessitates evaluating the impact of altered reconstitution volumes on PLLA's efficacy and safety.

Purpose of the Study:

• To evaluate the effectiveness and safety of PLLA for nasolabial fold correction using an 8 mL reconstitution volume with lidocaine.
• To compare this new protocol against a standard 5 mL reconstitution volume in the SCRIPT trial.

Main Methods:

• 80 subjects received PLLA reconstituted with either 8 mL sterile water for injection (SWFI) plus lidocaine or 5 mL SWFI, randomized 2:1.
• Treatments involved up to 4 sessions, with assessments of wrinkle severity, aesthetic improvement, and safety up to 48 weeks.
• The primary endpoint was the change in nasolabial fold severity using a validated wrinkle assessment scale (WAS).

Main Results:

• Both groups achieved high wrinkle assessment scale (WAS) responder rates at 24 weeks (≥75%) and 48 weeks (≥67%).
• High aesthetic improvement (≥86%) was observed throughout the study duration.
• Adverse events were predominantly mild and transient, with no compromise in safety noted for the higher volume group.

Conclusions:

• Poly-L-lactic acid (PLLA) reconstituted with 8 mL SWFI and lidocaine is comparable in efficacy to the 5 mL reference group for nasolabial fold wrinkle reduction.
• Higher reconstitution volumes, including lidocaine and immediate injection, do not compromise the safety profile of PLLA treatments.