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

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.

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.

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.

The PDLLA based product demonstrated non-inferiority to PLLA for NLF correction. Further studies are needed to assess long-term safety.