Restoring long‐lasting midface volume in the Asian face with a hyaluronic acid filler: A randomized controlled multicenter study

Abstract Background Hyaluronic acid (HA) filler treatment is a minimally‐invasive alternative to surgery to volumize the cheeks. HA VOL (Restylane ® Volyme) is a flexible HA filler suited to contouring and volumizing the midface. Methods This randomized, evaluator‐blinded, no‐treatment controlled study evaluated effectiveness and safety of HA VOL for correction of midface volume deficit and midface contour deficiency in Chinese subjects. In total 111 subjects were randomized to HA VOL and 37 to no treatment (control). The primary endpoint was response, on the blinded evaluator‐assessed Medicis Midface Volume Scale (MMVS), at 6 months after last injection for the treatment group and 6 months after randomization for controls, where response was defined as ≥1‐point improvement from baseline on both sides of the face. Results HA VOL was superior to no treatment at 6 months, meeting the primary objective: 76% versus 8% MMVS responders, a difference of 68% (CI: 55.7%–79.4%, p < 0.0001). These effects were sustained in 51% at 12 months after last injection. A majority (≥96%) had improved aesthetic appearance of midface fullness at Month 1 (using the Global Aesthetic Improvement Scale [GAIS]), effects which remained in ≥80% up to 12 months. Volume change captured by 3D photography increased after 1 month to 3.6 mL (close to the total injected volume of 3.4 mL), and remained stable through 12 months. Over 97% reported satisfaction with results after treatment with HA VOL . Additionally, HA VOL was well tolerated, with no unanticipated related adverse events. Conclusions This study showed that HA VOL is effective and well tolerated for midface treatment in a Chinese population.