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 (HARD, 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 HARD compared to Restylane (HAR, 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 HARD or HAR, Chinese adults (n = 173) with moderate or severe wrinkle severity of both NLFs received treatment with HARD on one NLF, and HAR 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 HARD and HAR, respectively). HARD was non‐inferior to HAR; 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 (HARD) was less painful. Conclusions HARD was non‐inferior to HAR for treatment of moderate‐to‐severe NLFs at 6 months post‐treatment. Overall, the results from this study indicate that HARD is safe and effective up to 12 months in a Chinese population.