Clinical comparison between two hyaluronic acid-derived fillers in the treatment of nasolabial folds in Chinese subjects: BioHyalux versus Restylane

Abstract

Hyaluronic acid fillers are used to improve the appearance of nasolabial folds (NLF). This study aimed to compare the efficacy, safety, and durability of a new hyaluronic acid gel (BioHyalux) versus Restylane for the correction of NLF. This was a multicenter, double-blinded, randomized, controlled, non-inferiority clinical trial involving 88 subjects with moderate to severe NLF. Subjects were randomized to BioHyalux and Restylane on either sides of the NLF. NLF was assessed before and right after injection, and at 1 week, 1, 3, and 6 months. Patients were followed up for 13-15 months to evaluate the durability and long-term safety. A clinically meaningful response was predefined as at least one-point improvement on the Wrinkle Severity Rating Scale, which is a five-point scale. At 6 months, the response rate of BioHyalux was not inferior to that of Restylane (P < 0.05). At the 13-15 months follow-up, the response rate by investigators was 58.0 % on the BioHyalux side versus 63.8 % on the Restylane side. The response rate by subjects showed similar results, which was 56.5 % on the BioHyalux side versus 60.9 % on the Restylane side at 13-15 months. The subjects' Global Aesthetic Improvement Scale (GAIS) showed that most subjects felt improvements on both sides of NLF (P > 0.05) at all time points. At 6 months, 100 % reported improvements on both side; at 13-15 months, 60 % of subjects reported improvements with BioHyalux versus 64 % with Restylane. Adverse events were transient and predominantly mild or moderate in severity including injection site swelling, pain, itching, bruising, and tenderness. BioHyalux had reliable safety and tolerance, and could be an effective injectable filler for correcting NLF.

A Multicenter Noninferiority Study Comparing Safety and Effectiveness of Hyaluronic Acid Fillers for Correction of Nasolabial Folds in Chinese Subjects

“…The demographic data were comparable to published studies in Chinese subjects for treatment of NLFs with HA fillers. 19,22,23 The primary effectiveness variable in this study was the difference in response rates between the BEL-and REStreated side at month 6, as assessed by the blinded evaluator according to the WSRS. of BEL versus RES was successfully demonstrated.…”

“…A split-face design was used in many previous clinical studies in the NLF indication in China. [19][20][21][22][23] RES was used as control device of similar effectiveness compared with BEL, with the exception that BEL contains 0.3% lidocaine to reduce injection pain.…”

“…24 The prespecified noninferiority margin was 10% as commonly used in noninferiority studies in aesthetics medicine. 19 The unadjusted difference in response rates was estimated using a similar RMM but with treatment as the only independent variable. The two-sided 95% Newcombe-Wilson CIs for paired data 25 were also provided.…”

“…Furthermore, it has served as a control device in several split-face design studies in Asian and, especially, Chinese subjects. [18][19][20][21][22][23]…”

Application of Hyaluronic Acid as a Biopolymer Material in Reconstruction of Interdental Papilla in Rats

“…Until now, various brands of HA products were used in the procedure of interdental papilla reconstruction. Among them, the most frequently used one is Restylane, a biphasic HA filler with a concentration of HA of 20 mg/ml (Wu et al, 2016). The present study used a domestic commercially available product with a similar concentration of HA to conduct the injection procedure.…”