Subjects receiving HARC for cheek augmentation were satisfied with the outcome following treatment and remained so throughout the study, as per mean Rasch Transformed FACE-Q total scores (range, 0–100). Subject satisfaction with appearance of their cheeks, and satisfaction with treatment outcome ranged from 74–85 (baseline: 39) and 67–76, respectively for Group A HARCsubjects. Group B subjects had similar level of satisfaction regardless of injection tool; 75–92 (baseline: 34) and 67–81, respectively (Figure 5).
By week 48, a majority of HARC subjects in Group A were assessed as having improvement in cheek augmentation by independent photographic review (left side: 66%; right side: 65%). For Group B, improvement was comparable between HARC injected by cannula and by needle.
For cheek volume calculated using digital 3D photography, the mean change from baseline in HARC subjects decreased over time and ranged from 3.3–2.7 mL for left side and 3.2-2.6 mL for right side of the face, across all timepoints. There was no notable difference in the volume increase between injection tools (needle vs cannula) at any visit.
Safety
As expected, most subjects in both group A (HARC and Control) and Group B (cannula and needle) reported pre-defined symptoms through subject diaries. The majority generally lasted 1–3 days.
Adverse events related to treatment or injection procedure included 21 (14.9%) HARC subjects and 13 (19.1%) Control subjects who experienced 57 and 79 related AEs, respectively (Table 3). No serious related adverse events were reported. In Group A, most related adverse events were classified as mild;
