Effectiveness
At week 12, the majority of patients (75.6%) in the treatment group showed a 1-point or greater improvement on the MJAS in both jawlines when compared to baseline. The responder rates were significantly greater than 50% in the treatment group (P<0.0001), meeting the threshold for clinical effectiveness (Figure 3). In contrast, only 8.8% of patients in the control group were responders.
A statistically significant difference of 66.8% (P<0.0001) was demonstrated between the response rates in the treatment and the control groups. The 95% confidence interval (CI) for the difference in response rates was [53.7%, 75.2%], showing a lower bound greater than zero. Representative before and after treatment photographs are shown in Figure 4.
Similar results were also observed when stratifying MJAS responder rates at week 12 by Fitzpatrick skin type categories (difference in response rates between treatment and control group [95% CI]: I-III = 65.2% [47.5%, 75.1%] and IV-VI = 70.6% [48.2%, 82.0%]) and sex (females = 70.6% [56.1%, 79.0%] and males = 51.3% [17.0%, 70.8%]) with lower bounds of CIs greater than zero in both skin type categories and in both males and females.
Regarding durability, 76/113 (67.3%) patients who responded to treatment 12 weeks after initial injection also retained response 48 weeks after initial treatment. A small subset of patients who were responders at week 12 and did not receive re-treatment, retained response up to 60 weeks post-initial treatment (7/17, 41.2%).
For the FACE-Q Satisfaction with Lower Face and Jawline module, the mean (SD) Rasch-transformed scores in patients randomized to the treatment group increased from 21.5 (18.9) at baseline to 75.2 (22.3) at week 12. The mean (SD) change from baseline to week 12 was 53.9 (25.7), and the respective 95% CI of [49.2, 58.7] excluded zero. Overall, the improvement in mean Rasch-transformed scores indicated a better outcome, with patients reporting being more satisfied with how prominent and how sculpted their jawline looked, how their jawline looked in profile, how nice their lower face looked, and how smooth their face looked.
All but one (99.1%) patient in the treatment group showed some level of improvement on the GAIS, as determined by the treating investigator (Figure 5). The remaining patient was reported to show no change in the treating investigator’s judgment. The
