A multicenter study of the efficacy and safety of subcutaneous nonanimal stabilized hyaluronie acid in aesthetic facial contouring: Interim report

BACKGROUND Nonanimal stabilized hyaluronic acid (NASHA) gel may offer longer-lasting cosmetic correction and lower antigenic risk than other soft-tissue augmentation agents. OBJECTIVE To assess the efficacy and safety of the NASHA gel, Restylane (R) SubQ, in aesthetic facial contouring. METHODS Fifty-seven adult patients seeking cheek and/or chin augmentation received subcutaneous and/or supraperiostal injections of Restylane (R) SubQ (20 mg/mL) at 114 treatment sites; 13 of these patients received '' touch-up '' injections at 20 sites. Efficacy was assessed subjectively using a 5-grade Global Aesthetic Improvement Scale (GAIS) at 1, 3, 6, 9, and 12 months after the initial treatment. RESULTS At 3 months postbaseline, patients and investigators independently considered the treatment sites to be improved in 96.4% and 100% of cases, respectively. Patient and investigator-assessed response rates (proportion of patients showing moderate or better improvement) were 84% and 95%, respectively. The majority of reported adverse events were treatment related (local injection-site reactions, implantation complications, skin tightness, and skin induration), but these were generally of mild intensity and short lived. CONCLUSION Restylane (R) SubQ is well tolerated and maintains aesthetic correction of the cheeks and chin for at least 3 months after subcutaneous and/or supraperiostal treatment.