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.

[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.