literature supports both the effectiveness and safety of CaHA for injection along the jawline, from the mentum to the mandibular angle. Multiple authors have reported favorable results 6 and 12 months after product placement, noting both investigator and patient satisfaction.6-8,11,12 Few procedure-related adverse events, such as pain, erythema, edema, and bruising, were reported -- most of which were mild and resolved quickly without intervention. Overall, the reported safety profile of CaHA for improving jawline contour is favorable and comparable to other established treatment indications.
The purpose of this large, robust, randomized pivotal study was to investigate the safety and effectiveness of CaHA with lidocaine [CaHA (+); Radiesse (+), Merz North America, Raleigh, NC, USA] treatment in patients who desired improvement of moderate to severe loss of jawline contour and to support the recent US Food and Drug Administration (FDA) approval for this indication.
The purpose of this large, robust, randomized pivotal study was to investigate the safety and effectiveness of CaHA with lidocaine [CaHA (+); Radiesse (+), Merz North America, Raleigh, NC, USA] treatment in patients who desired improvement of moderate to severe loss of jawline contour and to support the recent US Food and Drug Administration (FDA) approval for this indication.
MATERIALS AND METHODS
Study Design
This was a 60-week, prospective, multicenter, randomized, controlled, rater-blinded, pivotal clinical study (ClinicalTrials. gov: NCT03583359).
All eligible patients were randomized (2:1 allocation ratio; Figure 1) to either treatment with CaHA (+) or to control/ delayed treatment (ie, untreated controls until primary endpoint assessment at week 12, when the controls were eligible for treatment).
Patients randomized to the treatment group received an initial CaHA (+) injection in both the right and left jawline and were assessed at week 4 for a touch-up in one or both jawlines to achieve optimal correction. These patients returned at week 12 for their primary effectiveness assessment. Patients in the treatment group were eligible to receive re-treatment with CaHA (+) at week 48. Patients randomized to the control group remained untreated until completion of the primary endpoint assessment at week 12; subsequently, they were treated with CaHA (+) and assessed 4 weeks later for a touch-up. These patients were not offered re-treatment. All patients were followed for at least 48 weeks post initial treatment and until the end of the study to assess long-term effectiveness and safety.
Institutional review boards of all participating sites reviewed the protocol and approved the study before enrolling the first patient.
Patients
Patients were recruited at 15 sites within the United States. To be considered for study inclusion, male and female patients had to be between 22 and 65 years of age with right and left jawline ratings of 2 or 3 (moderate or severe) on the Merz Jawline Assessment Scale (MJAS) and have symmetrical jawlines.
Key exclusion criteria included non-age-related skin or fat atrophy in the midfacial and/or jawline region or diagnosis of a connective tissue disorder; skin laxity and/or sun damage beyond typical of the patient's age; prior surgery on the jaw or in the jawline area or a permanent implant or graft in the lower face and/or jawline area; previous treatment with fat injections, permanent fillers, or semi-permanent fillers in the lower face or jawline area; treatment with porcine-based collagen fillers or CaHA fillers in the lower face and/or jawline area received within 24 months prior to randomization; and administration
This was a 60-week, prospective, multicenter, randomized, controlled, rater-blinded, pivotal clinical study (ClinicalTrials. gov: NCT03583359).
All eligible patients were randomized (2:1 allocation ratio; Figure 1) to either treatment with CaHA (+) or to control/ delayed treatment (ie, untreated controls until primary endpoint assessment at week 12, when the controls were eligible for treatment).
Patients randomized to the treatment group received an initial CaHA (+) injection in both the right and left jawline and were assessed at week 4 for a touch-up in one or both jawlines to achieve optimal correction. These patients returned at week 12 for their primary effectiveness assessment. Patients in the treatment group were eligible to receive re-treatment with CaHA (+) at week 48. Patients randomized to the control group remained untreated until completion of the primary endpoint assessment at week 12; subsequently, they were treated with CaHA (+) and assessed 4 weeks later for a touch-up. These patients were not offered re-treatment. All patients were followed for at least 48 weeks post initial treatment and until the end of the study to assess long-term effectiveness and safety.
Institutional review boards of all participating sites reviewed the protocol and approved the study before enrolling the first patient.
Patients
Patients were recruited at 15 sites within the United States. To be considered for study inclusion, male and female patients had to be between 22 and 65 years of age with right and left jawline ratings of 2 or 3 (moderate or severe) on the Merz Jawline Assessment Scale (MJAS) and have symmetrical jawlines.
Key exclusion criteria included non-age-related skin or fat atrophy in the midfacial and/or jawline region or diagnosis of a connective tissue disorder; skin laxity and/or sun damage beyond typical of the patient's age; prior surgery on the jaw or in the jawline area or a permanent implant or graft in the lower face and/or jawline area; previous treatment with fat injections, permanent fillers, or semi-permanent fillers in the lower face or jawline area; treatment with porcine-based collagen fillers or CaHA fillers in the lower face and/or jawline area received within 24 months prior to randomization; and administration
