Efficacy and Safety of Poly-l-Lactic Acid for Correction of Midfacial Volume Loss and Contour Defects: A Prospective, Multicenter, Randomized, Parallel-Controlled, Evaluator-Blinded, Superiority Trial.

BACKGROUND

Poly-l-lactic acid (PLLA) is widely used in esthetic medicine due to its excellent biocompatibility and biodegradability. This study aimed to evaluate the effectiveness and safety of PLLA facial filler in correcting midfacial volume loss and/or contour defects.

METHODS

In this prospective, multicenter, randomized, assessor-blinded, superiority clinical trial, 331 subjects were randomly assigned to receive either PLLA (experimental group) or hyaluronic acid (HA, control group). Efficacy was assessed using the Midfacial Volume Scale (MMVS) and Global Aesthetic Improvement Scale (GAIS). Safety was evaluated based on adverse events.

RESULTS

The PLLA group demonstrated significantly higher efficacy in MMVS scores compared to the HA group (90.57% vs. 51.01%, difference of 39.56%, 95% CI: 30.34%-48.78%). These results were consistent across worst-case and per-protocol analyses. Secondary outcomes revealed higher MMVS and GAIS scores in the PLLA group at 6 months (MMVS: 93.04% vs. 69.33%, GAIS investigator rating: 99.37% vs. 86.67%) and 12 months (MMVS: 84.91% vs. 46.98%, GAIS investigator rating: 94.34% vs. 74.50%) (p < 0.05). Participant satisfaction surveys showed higher satisfaction in the PLLA group (p < 0.05). Safety analysis revealed no significant differences in vital signs, laboratory tests, or adverse events (p > 0.05), with a slightly higher incidence of injection site reactions in the PLLA group, which resolved within 1-3 days.

CONCLUSION

The comprehensive analysis of results indicates that PLLA is a safe and effective treatment for the correction of midfacial volume loss and midfacial contour defects.