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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

Year: 2025

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

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 the effectiveness and safety of STYLAGE L filler (Laboratoires VIVACY, Archamps, France) vs a well-established comparator, Restylane (Galderma, Uppsala, Sweden), for correcting moderate-to-severe NLFs in Chinese subjects. METHODS: A 12-month, randomized, subject- and evaluator-blinded, controlled, parallel-group, noninferiority study was conducted across 8 hospitals in China. The primary endpoint was the 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 randomly allocated to the treatment (STYLAGE L) and control (Restylane) groups, respectively, and analyzed. In the primary endpoint analysis, noninferiority of STYLAGE L was demonstrated because the lower limit of the 95% CI was greater than -10% (difference in percentage of responders, 9.33%; 95% CI, 2.10%-16.56%). WSRS responder rates were statistically significantly higher in the treatment compared with the control group at 6 months (9.19%; 95% CI, 1.85%-16.54%; P = .0157), 9 months (19.75%; 95% CI, 10.97%-28.53%; P < .0001), and 12 months (11.36%; 95% CI, 2.64%-20.09%; P = .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 (ie, aspects were "harder") for STYLAGE L vs Restylane. CONCLUSIONS: The study demonstrated the noninferiority of STYLAGE L vs Restylane in correcting NLFs in Chinese subjects. Results up to 12 months suggest comparable safety and effectiveness profiles.

Source: Aesthetic Surgery Journal

DOI: 10.1093/asj/sjaf186