Abstract
Patients can have different reasons for seeking cheek augmentation; while some are in need of volume augmentation, others may request projection and lifting. A treatment guide can be useful for treating clinicians in choosing the most suitable product. This 8-week, multicenter study was conducted to evaluate the effectiveness and safety of cheek augmentation using a treatment guide to choose between study products HACON and HALYF. Female subjects intending to undergo cheek augmentation were treated according to primary need for treatment-HACON for contouring or HALYF for projection. Treatments were performed according to approved labels. Assessments included Global Aesthetic Improvement Scale (GAIS) evaluations, subject satisfaction, subject-perceived age (FACE-Q), naturalness of facial expressions, 3D imaging analysis, and safety assessments. All subjects (n = 60) were assessed as aesthetically improved by the investigators 4 and 8 weeks after last injection. For all subjects, contouring or projection was achieved as planned with natural-looking results. Subject satisfaction was high in both study groups. Volume change of the cheek area was statistically significant from baseline to Week 4 (p < 0.001), in both treatment groups and on both sides of the face. Overall, treatments were well tolerated with mainly mild adverse events related to treatment. The proposed guide for product selection of HACON or HALYF for treatment of the cheek area was useful to achieve the primary treatment goal for both products. Treatments were well tolerated and associated with improved aesthetic appearance of the cheeks as well as high subject satisfaction.
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