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

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.