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.

Abstract

Hyaluronic acid-based dermal fillers are commonly used to correct prominent nasolabial folds (NLFs), a hallmark of aging. 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. 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. 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. 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.