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.