majority of patients (94.0%) in the treatment group self-reported some level of improvement on the GAIS (Figure 5). Six (5.2%) patients reported seeing no change, and 1 (0.9%) patient reported looking worse when compared to baseline photographs. At least two blinded IPRs assessed that 53 (47.7%) of 111 patients in the treatment group and 4 (8.2%) of 49 patients in the control group showed a treatment response of 1-point or greater change on both jawlines, showing a difference of 39.6% [25.3%, 50.0%] between groups.
Furthermore, according to FACE-Q VAS, patients in the treatment group self-reported on average looking younger by approximately 3 years at week 12 when compared to baseline.
Safety
CaHA (+) was found to be tolerable and safe at up to three treatment sessions, and during the study's long-term follow-up period. Investigators reported at least one treatment emergent adverse event (TEAE) in 74/175 (42.3%) patients exposed to treatment. Three (3/175, 1.7%) patients had serious TEAEs that were unrelated to the treatment device. No TEAEs leading to study discontinuation were reported.
Overall, 46/175 (26.3%) patients had at least one TEAE that was deemed to be related to treatment by the investigator (Table 2). The most frequently reported treatment-related TEAEs were administration site conditions that were mild, lasted less than 15 days, and resolved without sequelae. Importantly, only one patient injected with needle had treatment-related TEAEs that were severe: injection site bruising (1 event, lasting 16 days) and injection site edema (1 event, lasting 16 days), and both events resolved. There were no treatment-related serious adverse events (SAEs). Only one patient (0.8%) had one mild treatment-related TEAE with unknown outcome due to being lost to follow-up.
Rates of treatment-related TEAEs were comparable between female (37/144, 25.7%) and male (9/31, 29.0%) subgroups. Rates of patients with treatment-related TEAEs were equally similar and favorable for Fitzpatrick skin type category I to III when compared to skin type category IV to VI (I-III = 30/109, 27.5% and IV-VI = 16/66, 24.2%).
Common treatment responses (CTRs) were self-reported by patients in electronic diaries for 28 days post-treatment. After initial treatment, the majority of patients reported CTRs (eg, swelling, firmness, lumps/bumps, bruising, and discomfort/pain) that were mild (81/175, 46.3%) to moderate (81/175, 46.3%) in nature and had a duration of 14 days or less (1-3 days: 22/175, 12.6%; 4-7 days: 68/175, 38.9%; and 8-14 days: 46/175, 26.3%). CTRs reported in the study were similar for all three diary cycles (initial treatment, touch-up, and retreatment), although incidences of subjects reporting at least 1 CTR tended to be lower after touch-up (77.8%) and re-treatment when compared to initial treatment.
