A Prospective, Open-Label, Post Marketing Study of the Safety and Effectiveness of a Hyaluronic Acid and Calcium Hydroxyapatite Hybrid Injectable.

[BACKGROUND] HA-CaHA is a hybrid injectable combining hyaluronic acid and calcium hydroxyapatite for dual-mode facial soft tissue augmentation. HA-CaHA-L includes 0.3% lidocaine HCL.

[OBJECTIVE] This prospective, open-label study evaluated the effectiveness and safety of HA-CaHA for treating midface volume deficit.

[METHODS] Adults rated Moderate to Severe on the Allergan Midface Volume Deficit Scale (MFVDS) received HA-CaHA (n = 110) or HA-CaHA-L (n = 30) in the cheek (primary injection region) and jawline (optional) areas, with optional touch-up 2 weeks later. Follow-up visits occurred at Months 1, 3, 6, 9, and 12. The primary endpoint was the MFVDS responder rate (≥ 1-grade improvement from baseline) at Month 1. Secondary endpoints were the Global Aesthetic Improvement Scale (GAIS) responder rates and change from baseline on FACE-Q Satisfaction with Cheeks and Satisfaction with Facial Appearance. Exploratory endpoints were the Allergan Cheek Smoothness Scale (ACSS) scores and 3D photo-based midface movement tracking. Safety was assessed throughout.

[RESULTS] At Month 1, MFVDS responder rate was 82.8%, remaining high through Month 12. The GAIS responder rates were 98.5% (investigator-rated) and 91.8% (participant-rated) at Month 1, remaining high through Month 12. FACE-Q scores improved 33.3 (Cheeks) and 23.8 (Facial Appearance) points at Month 1, remaining high through Month 12. ACSS scores peaked at Months 3 (73.7%) and 6 (69.2%), with corresponding skin movement changes. Most participants (95.7%) experienced mild or moderate ISRs. The most common treatment-related AEs were injection site pain (11.4%), injection site mass (10.7%), and headache (7.1%).

[CONCLUSIONS] HA-CaHA and HA-CaHA-L are effective and well-tolerated for midface soft tissue augmentation, lasting up to 1 year.