Safety and Effectiveness of Hyaluronic Acid Injectable Gel in Correcting Moderate Nasolabial Folds in Chinese Subjects
January 2016 | Volume 15 | Issue 1 | Original Article | 70 | Copyright © January 2016
Yan Wu MD PhD,a Jinhua Xu PhD,b Yi Jia MD MSc PhD,c and Diane K. Murphy MBAd
aPeking University First Hospital, Beijing, China
bHuaShan Hospital, FuDan University, Shanghai, China
cAllergan China, Beijing, China
dAllergan, Inc., Irvine, CA
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.
J Drugs Dermatol. 2016;15(1):70-76.