A randomized, multicenter study on a flexible hyaluronic acid filler in treatment of moderate‐to‐severe nasolabial folds in a Chinese population

Abstract Background Restylane Defyne (HA RD , with lidocaine) has been shown to be effective and safe for facial augmentation including nasolabial folds (NLFs) in Caucasians. Incorporating lidocaine in injectable fillers has become a common practice that improves the patient's experience. Objectives To evaluate efficacy and safety of HA RD compared to Restylane (HA R , the gold standard HA filler) for correction of NLFs in a Chinese population. Methods In this 12‐month, randomized, split‐face, evaluator‐blinded study of the efficacy and safety of treatment of NLFs with HA RD or HA R , Chinese adults ( n = 173) with moderate or severe wrinkle severity of both NLFs received treatment with HA RD on one NLF, and HA R on the opposite NLF. Results The primary objective was met: WSRS response rates at Month 6 (i.e., ≥1‐grade improvement according to the blinded evaluator) were similar (72.9% and 72.8% for HA RD and HA R , respectively). HA RD was non‐inferior to HA R ; the 95% CI for the difference in response rates was −5.7% to 5.5%. Likewise, products were effective and comparable in terms of reduced wrinkle severity of NLFs and improved Global Aesthetic Improvement Scale (GAIS) score (according to the blinded evaluator and subject) throughout the study. Both products were well‐tolerated, and injection of the lidocaine‐containing product (HA RD ) was less painful. Conclusions HA RD was non‐inferior to HA R for treatment of moderate‐to‐severe NLFs at 6 months post‐treatment. Overall, the results from this study indicate that HA RD is safe and effective up to 12 months in a Chinese population.