A Multicenter Study of the Efficacy and Safety of Subcutaneous Nonanimal Stabilized Hyaluronie Acid in Aesthetic Facial Contouring: Interim Report


Address correspondence and reprint requests to: Claudio DeLorenzi, MD, FRCS, 11 Agnes Street, Kitchener, Ontario, Canada N2G 2E7, or e-mail: delorenzi@golden.net.


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® SubQ, in aesthetic facial contouring.

METHODS Fifty-seven adult patients seeking cheek and/or chin augmentation received subcutaneous and/or supraperiostal injections of Restylane® 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® SubQ is well tolerated and maintains aesthetic correction of the cheeks and chin for at least 3 months after subcutaneous and/or supraperiostal treatment.