Effectiveness and Safety of a Cross-Linked Hyaluronic Acid Plus Mannitol Filler for the Correction of Nasolabial Folds in Chinese Subjects: A Randomized, Blinded, Controlled Study.
Yan Wu, Benjamin Ascher, Zhiyong Yang, Hongsen Bi, Li Li, Hongyi Zhao, Hang Wang, Jinming Zhang, Sheng-Kang Luo
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引用次数: 0
Abstract
Background: Hyaluronic acid-based dermal fillers are commonly used to correct prominent nasolabial folds (NLFs), a hallmark of aging.
Objectives: This study aimed to verify effectiveness and safety of the investigational device STYLAGE® L (Laboratoires VIVACY, Archamps, France) versus a well-established comparator Restylane® (Galderma, Uppsala, Sweden) in correcting moderate to severe NLFs in Chinese subjects.
Methods: A 12-month, randomized, subject- and evaluator-blinded, controlled, parallel-group, non-inferiority study conducted across 8 hospitals in China. The primary endpoint was percentage of Wrinkle Severity Rating Scale (WSRS) responders 6 months after last treatment. Secondary endpoints included Global Aesthetic Improvement Scale (GAIS) responders, subject satisfaction, device performance, and tolerance.
Results: In total, 194 and 196 subjects were randomized to the treatment and control group, respectively, and analyzed. In the primary endpoint analysis, non-inferiority of the investigational device was demonstrated as the lower limit of the 95% confidence interval (CI) was greater than -10% (difference [95% CI] in percentage of responders: 9.33% [2.10%, 16.56%]). WSRS responder rates were statistically significantly higher in the treatment than the control group at 6 months (9.19% [1.85%, 16.54%], p=0.0157), 9 months (19.75% [10.97%, 28.53%], p<0.0001), and 12 months (11.36% [2.64%, 20.09%], p=0.0116). GAIS responder rates were high in both groups throughout the study (>73%). Subject satisfaction was high. Both devices were well-tolerated. Device performance scores were statistically significantly higher (i.e. aspects were 'harder') with the investigational device versus the comparator.
Conclusions: Non-inferiority of the investigational device versus the comparator in correcting NLFs in Chinese subjects was demonstrated. Results up to 12 months suggest comparable safety and effectiveness profiles.
期刊介绍：
Aesthetic Surgery Journal is a peer-reviewed international journal focusing on scientific developments and clinical techniques in aesthetic surgery. The official publication of The Aesthetic Society, ASJ is also the official English-language journal of many major international societies of plastic, aesthetic and reconstructive surgery representing South America, Central America, Europe, Asia, and the Middle East. It is also the official journal of the British Association of Aesthetic Plastic Surgeons, the Canadian Society for Aesthetic Plastic Surgery and The Rhinoplasty Society.
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