A Randomized, Evaluator-Blinded, Multicenter Study to Compare Injectable Poly-D,L-Lactic Acid vs Hyaluronic Acid for Nasolabial Fold Augmentation.

BACKGROUND: Injectable poly-D,L-lactic acid (PDLLA), under the brand name of AestheFill (REGEN Biotech, Inc., Seoul, South Korea), is a biocompatible, biodegradable, and biostimulatory product utilized to correct soft tissue volume loss. Its efficacy and safety have not been fully studied in a large cohort. OBJECTIVES: The aim of the study was to evaluate the efficacy and safety of a novel dermal filler injectable, poly-D,L-lactic acid. METHODS: This was an evaluator-blinded, multicenter, randomized controlled trial to compare the efficacy and safety of PDLLA vs hyaluronic acid in the correction of the nasolabial fold. Two hundred and sixty patients with moderate to severe nasolabial folds were enrolled and randomized to the treatment group (PDLLA) or control group (hyaluronic acid). Each patient received a PDLLA or hyaluronic acid injection for nasolabial fold augmentation and was followed for 52 weeks. The Wrinkle Severity Rating Scale (WSRS) and Global Aesthetic Improvement Scale (GAIS) were applied to evaluate topical nasolabial fold augmentation and overall improvement, respectively. RESULTS: At 24 weeks, 67.6% of patients in the PDLLA group had an at least 1-grade improvement on the WSRS, compared to 60.9% of patients in the control group with an at least 1-grade improvement on the WSRS (P < .05). At each visit, the PDLLA group showed more improvement on the baseline WSRS than the control group. PDLLA was safe and well tolerated, with no severe adverse events. CONCLUSIONS: PDLLA shows noninferior efficacy in correcting nasolabial folds compared to hyaluronic acid.