and the corresponding 2-sided 95% CI; mean difference HARC- Control: -0.1 (95% CI: -0.22, 0.06). Subgroup analyses by FST (I–III, IV, and V–VI), race and ethnicity confirmed the robustness of the primary analysis. In addition, midface fullness improvement was comparable with both needle and cannula devices; week 12 MMVS mean change from baseline: -1.3 (needle); -1.3 (cannula), 95% CI for the difference: -0.15, 0.05.
A majority of Group A HARC subjects were assessed as MMVS responders on both sides of the face throughout the study, ranging from 91% at week 12 to 63% at week 48 (Figure 1). Also, no notable difference was observed at any visit in MMVS response for Group B subjects injected using needle vs cannula (Figure 1). In order to show the versatility of the product, representative subject photographs of a male and female subject with different ethnicities, treated with HARC are presented in Figure 2 and Figure 3, respectively.
In Group A, subject assessment of aesthetic improvement in the midface using GAIS showed high levels of improvement that was maintained 48 weeks after treatment (95%-77%), and similar improvement was observed from assessments made by treating investigators (Figure 4). GAIS scores in Group B were similar for HARC injected by cannula (91–97%) and needle (89–97%) according to subject assessments, in line with treating investigators that scored 93–100% of subjects as improved during the study, with no differences between the injection tools (Figure 4).
