A Split Face Study Comparing the Effect of a PDLLA Based Product and PLLA on the Nasolabial Fold (NLF).

BACKGROUND: Injectable Poly-L-lactic acid (PLLA) is effective in restoring mid-face volume and is widely used treating the nasolabial fold (NLF). This study aimed to compare the safety and efficacy of a novel PDLLA based product (PDLLA + non-cross-linked HA; Poly-D, L-lactic acid + hyaluronic acid) with that of a commonly used PLLA for NLF correction. METHODS: In this multi-center, randomized, split-face, evaluator-blinded study, 33 subjects received injections of the PDLLA based product on one NLF and PLLA injection on the other (three injections total, administered at 4-week intervals). Wrinkle severity was assessed using standardized photographs taken at baseline (week 0); before the second and third injections (weeks 4 and 8); 4 weeks after the third injection (week 12); and 3 months after the final injection (week 24) using the Wrinkle Severity Rating Scale (WSRS). Safety data were collected through subject interviews and case report forms. RESULTS: Both the PDLLA based product and PLLA significantly improved NLF wrinkle severity at all time points compared to baseline (p < 0.001). The degree of improvement was comparable between the two products throughout the observation period. CONCLUSION: The PDLLA based product demonstrated non-inferiority to PLLA for NLF correction. Further studies are needed to assess long-term safety.