Restoring long-lasting midface volume in the Asian face with a hyaluronic acid filler: A randomized controlled...

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.

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.

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.

This study showed that HA_VOL is effective and well tolerated for midface treatment in a Chinese population.