Safety and Effectiveness of Hyaluronic Acid Injectable Gel in Correcting Moderate Nasolabial Folds in Chinese Subjects.

[BACKGROUND] The hyaluronic acid (HA) dermal filler, Juvéderm® Ultra, which employs Hylacross® technology, produces a gel with a smooth consistency and has demonstrated effectiveness in correcting nasolabial folds (NLFs) in Caucasian populations.

[OBJECTIVE] To evaluate the safety and effectiveness of Juvéderm Ultra vs Restylane® for the correction of moderate NLFs in Chinese subjects.

[METHODS] In this double-blind randomized study, adult Chinese subjects with moderate NLFs received Juvéderm Ultra (24 mg/mL) in 1 NLF and Restylane injectable gel (20 mg/mL) in the other NLF. NLFs were evaluated using the validated 5-point photonumeric Allergan NLF Severity Scale (NLFSS); scores ranged from 0 ("no wrinkle") to 4 ("very deep wrinkle"). Response was defined as ≥1-point improvement at 6 months. Investigator-assessed responder rate (primary outcome), NLF mean improvement, and subject-assessed responder rate and preference were assessed.

[RESULTS] Among the 104 subjects who completed the study, median initial volumes (mL) were 0.8 (range, 0.2-1.4) for Juvéderm Ultra and 0.8 (0.3-1.5) for Restylane; median touch-up volumes were 0.3 (0.1-0.5) and 0.3 (0.1-0.5), respectively. At 6 months, investigator-assessed responder rates were 87.3% for both products, indicating that Juvéderm Ultra was noninferior to Restylane; mean improvement in NLFSS scores from baseline was 1.0 for both products. At 6 months, Juvéderm Ultra and Restylane subject-assessed responder rates were 86.3% and 79.4%, respectively, and mean improvement in NLFSS scores from baseline was 1.2 and 1.0, respectively. Among subjects who expressed a preference, 57.9% preferred Juvéderm Ultra. For both products, the most commonly reported treatment site responses were swelling, firmness, and tenderness; treatment site responses were generally mild or moderate in severity. Juvéderm Ultra had fewer severe responses than Restylane.

[CONCLUSIONS] Juvéderm Ultra is noninferior to Restylane and is a safe and effective treatment for correcting moderate NLFs in Chinese subjects.