with a mean volume of 4.7 mL study product, including touchup (HAR: 3.6 mL; HARL: 4.2 mL). At the second treatment, 94 subjects received a total mean volume of 3.1 mL study product, including touch-up (HAR: 2.4 mL; HARL: 3.0 mL).
All subjects (100%) were injected in upper cheeks, and 88% and 84% received treatment in nasolabial folds and chin, respectively (Table 1). Injection details per indication are presented in Table 2.
Effectiveness
GAIS
Six months after first treatment, 95% (CI: 89%–98%) of subjects assessed themselves as improved (improved/much improved/ very much improved; Figure 2). The primary endpoint of the study was thus met as the entire confidence interval was above 50%.
Twelve months after first and second treatment, 88% and 93% of subjects assessed themselves as improved, respectively (Figure 2). At least 94% of subjects were assessed as improved by the investigators up to six months after each treatment, and ≥82% of subjects were assessed as improved up to 12 months after both treatments (Figure 2). Photographs of a representative study subject are provided in Figure 3. At least 74% of subjects were assessed as improved by the blinded evaluators six month after both treatments, and ≥70% of subjects 12 months after both treatments (Figure 2).
Subject Satisfaction
Subject expectations prior to treatment mostly included that they wanted to improve their facial appearance (86%) and to look younger (75%). Subject satisfaction with facial appearance increased from 15% at baseline to 88% three months after first treatment. Most subjects (73–90%) were satisfied with the treatment results throughout the study; ≥80% were satisfied 12 months after both treatments. At least 96% of subjects would do the treatment again.
First Impression
Overall first impression (ie, the sum of scores from all eight categories), assessed from photographs on a computer screen, was similar for the baseline and post-treatment assessments, with mean scores varying from 40.3 to 41.1. Correspondingly, no sub-scale measured separately showed any significant change from baseline.
Upper Cheek Fullness
Six months after first and second treatment, at least 66% and 67% of cheeks were assessed as improved (≥1-step improvement from baseline), respectively. Long-term improvement rate 12 months after treatment was significantly higher after second treatment (≥69%), compared to after first treatment (≥38%; P:<0.0001, Fisher’s exact test; Figure 4).
The blinded evaluators’ retrospective assessment using photographs showed lower improvement rate compared to investigators, with 24%–29% improved cheeks on the right side, and 18%–33% on the left side, during the study.
