Safety and Effectiveness of a Crosslinked Hyaluronic Acid Filler in Korean Patients for the Correction of Nasolabial Folds: A Randomized, Patient- and Evaluator-Blinded, Paired Study

초록

Background Hyaluronic acid (HA) dermal fillers are widely used as a nonsurgical treatment for facial aging, including nasolabial folds (NLFs). Because demand for convenient aesthetic procedures increases, new HA products require rigorous comparison with established fillers.Objectives The aim of this study was to assess the noninferiority and safety of a new crosslinked HA filler, SkinPlus-HYAL Implant Lidocaine (test), vs RESTYLANE Lidocaine (control) for temporary correction of moderate to severe NLFs.Methods In this multicenter, randomized, patient- and evaluator-blinded, split-face study, 100 adults with moderate or severe NLFs received the test filler in 1 NLF and the control in the contralateral NLF. Efficacy was analyzed in the full analysis set (n = 93). The primary endpoint was the between-treatment difference in Wrinkle Severity Rating Scale (WSRS) scores at Week 24. Safety was evaluated in the safety set (n = 100). Group differences were analyzed using a 2-sample t-test.Results At Week 24, mean WSRS scores were 1.85 +/- 0.72 (test) and 1.84 +/- 0.68 (control). The mean difference (test - control) was 0.01 +/- 0.48, with an upper 97.5% 1-sided confidence limit of 0.2136, below the prespecified noninferiority margin of 0.29. Investigator-rated Global Aesthetic Improvement Scale (GAIS) scores at Week 24 and patient-rated GAIS scores at Week 8 favored the test filler. Local adverse events were more frequent with the test (92.00%) than the control (82.0%), but severe injection-site reactions were uncommon, and no serious adverse events occurred.Conclusions SkinPlus-HYAL Implant Lidocaine was noninferior to RESTYLANE Lidocaine for correction of moderate to severe NLFs and maintained efficacy through 48 weeks. Despite a higher rate of local reactions, its overall safety profile was acceptable, supporting its use as an effective, safe option for facial aesthetic augmentation.