RESULTS
Demographics and Treatment
In Group A, 142 subjects were randomized to HARC and 68 to Control. A total of 60 subjects were included in Group B (splitface treatment with HARC). The FST enrollment goal of the study was met. Baseline demographics in Group A and Group B were similar; mean age was 53 and 52 years, respectively, and the majority of subjects were female (89% in Group A and 92% in Group B (Table 1). A majority of all subjects in Group A (57- 61%) and Group B (52-57%) had MMVS score 3, ie moderate loss of midface fullness at baseline (Table 1). For Group A, total mean volume injected for initial and touch-up treatment was statistically less for HARC than Control (4.3 mL and 4.9 mL, respectively, P=0.0134, post-hoc calculation). Total mean volume HARC injected for Group B (initial and touch-up treatment) was 4.2 mL (2.10 mL for cannula and 2.07 mL for needle). Injection characteristics in terms of injection depth, method, and tool, are summarized in Table 2.
Effectiveness
The primary endpoint comprising non-inferiority of HARC to Control for cheek augmentation and correction of midface contour deficiencies was established based on MMVS change from baseline at week 12, as assessed by blinded evaluation
In Group A, 142 subjects were randomized to HARC and 68 to Control. A total of 60 subjects were included in Group B (splitface treatment with HARC). The FST enrollment goal of the study was met. Baseline demographics in Group A and Group B were similar; mean age was 53 and 52 years, respectively, and the majority of subjects were female (89% in Group A and 92% in Group B (Table 1). A majority of all subjects in Group A (57- 61%) and Group B (52-57%) had MMVS score 3, ie moderate loss of midface fullness at baseline (Table 1). For Group A, total mean volume injected for initial and touch-up treatment was statistically less for HARC than Control (4.3 mL and 4.9 mL, respectively, P=0.0134, post-hoc calculation). Total mean volume HARC injected for Group B (initial and touch-up treatment) was 4.2 mL (2.10 mL for cannula and 2.07 mL for needle). Injection characteristics in terms of injection depth, method, and tool, are summarized in Table 2.
Effectiveness
The primary endpoint comprising non-inferiority of HARC to Control for cheek augmentation and correction of midface contour deficiencies was established based on MMVS change from baseline at week 12, as assessed by blinded evaluation
