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 © 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

Abstract

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.

J Drugs Dermatol. 2016;15(1):70-76.

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INTRODUCTION

Changes in facial appearance due to aging can have a negative impact on an individual’s psychological and social well-being.1,2 Signs of aging can lead to increased anxiety and depression and create facial miscues leading to misinterpretation of an individual’s emotional state.2,3 With aging, loss of skin elasticity due to epidermal thinning and decreased collagen causes the skin to loosen and sag, leading to the formation of folds and wrinkles.4,5 Volume loss due to fat displacement also occurs with aging and contributes to the sagging and laxity of the face.6 With loss of deep fat in the midface, muscle contour is altered7; the resulting sagging may have effects across the face, contributing to nasolabial folds (NLFs) and wrinkles.4

Hyaluronic acid (HA)-based fillers have been used for facial aesthetic procedures to reduce the appearance of folds, provide volume, and restore natural contour. Juvéderm® Ultra injectable gel (Allergan, Inc., Irvine, CA, USA) belongs to a family of HA dermal fillers that employs the proprietary Hylacross® technology (Allergan, Inc.), which produces a gel with a smooth consistency.8 The effectiveness of Juvéderm Ultra for NLF correction has been demonstrated in a 6-month study which showed clinically significant improvement from baseline on the 5-point Wrinkle Assessment Scale (former name of the 5-point photonumeric Allergan NLF Severity Scale [NLFSS] used in this study) at all time points.9 Clinically significant improvement in NLF correction was also reported beyond 9 months after treatment with Juvéderm Ultra10 and up to 1 year after repeat treatment performed 6 to 9 months after initial treatment.11 A meta-analysis of different types of HA fillers for NLF correction showed that the Juvéderm family of fillers resulted in the most effective treatment.12 The majority of published studies on NLF

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