A Randomized, Comparator-Controlled Study of HARC for Cheek Augmentation and Correction of Midface Contour Deficiencies

Abstract

Background: HARC is a soft and flexible hyaluronic acid filler containing lidocaine, manufactured using XpresHAn® technology, restoring natural-looking volume and soft contours. Objectives: To evaluate safety and effectiveness of Do HARC for Not cheekCopy augmentation and correction of midface contour deficiencies compared to a control product HAJV (hereafter referred Penalties to as Control).Apply Primary objective was to demonstrate non-inferiority of HARC compared to the Control, by blinded evaluation of change from baseline in midface fullness 12 weeks after last injection, using a 4 grade midface volume scale (MMVS). Materials and Methods: Subjects over the age of 21 with loss of fullness in the midface area (MMVS score 2, 3, or 4) were randomized 2:1 to treatment with HARC (n=142) or Control (n=68). Optional touch-up was allowed after 4 weeks. Study assessments included MMVS, aesthetic improvement, subject satisfaction, and safety. Subjects were followed for 48 weeks. Results: Overall, most subjects were female (89%) and mean age was 53 years (range 24-80). Total mean volume injected was 4.3 mL for HARC and 4.9 mL for Control. Primary objective was met; mean change from baseline in MMVS score at week 12: -1.4 (HARC), -1.3 (Control), 95% CI: -0.22, 0.06. HARC effectiveness was supported by a high degree of aesthetic improvement and subject satisfaction throughout 48 weeks. Related adverse events were generally mild and transient. Conclusions: HARC was well tolerated and non-inferior to Control for correction of midface fullness at 12 weeks after last injection. Aesthetic improvement and subject satisfaction were high and lasted through week 48.