A Prospective, Open‐Label, Post Marketing Study of the Safety and Effectiveness of a Hyaluronic Acid and Calcium Hydroxyapatite Hybrid Injectable
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2025
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| author | Alessandro Gritti Malka Salomon Lea Elmaleh Graeme Kerson Andrew Schumacher |
| author_facet | Alessandro Gritti Malka Salomon Lea Elmaleh Graeme Kerson Andrew Schumacher Alessandro Gritti Malka Salomon Lea Elmaleh Graeme Kerson Andrew Schumacher |
| collection | Wiley Open Access |
| contents | A Prospective, Open‐Label, Post Marketing Study of the Safety and Effectiveness of a Hyaluronic Acid and Calcium Hydroxyapatite Hybrid Injectable Alessandro Gritti Malka Salomon Lea Elmaleh Graeme Kerson Andrew Schumacher Journal of Cosmetic Dermatology ABSTRACT 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. 10.1111/jocd.70430 http://creativecommons.org/licenses/by/4.0/ |
| doi_str_mv | 10.1111/jocd.70430 |
| format | Artículo Open Access |
| id | wiley_oa_10_1111_jocd_70430 |
| institution | Wiley Open Access |
| license_str_mv | http://creativecommons.org/licenses/by/4.0/ |
| publishDate | 2025 |
| publisher | Wiley |
| record_format | wiley_oa |
| spellingShingle | A Prospective, Open‐Label, Post Marketing Study of the Safety and Effectiveness of a Hyaluronic Acid and Calcium Hydroxyapatite Hybrid Injectable Alessandro Gritti Malka Salomon Lea Elmaleh Graeme Kerson Andrew Schumacher Journal of Cosmetic Dermatology A Prospective, Open‐Label, Post Marketing Study of the Safety and Effectiveness of a Hyaluronic Acid and Calcium Hydroxyapatite Hybrid Injectable Alessandro Gritti Malka Salomon Lea Elmaleh Graeme Kerson Andrew Schumacher Journal of Cosmetic Dermatology ABSTRACT 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. 10.1111/jocd.70430 http://creativecommons.org/licenses/by/4.0/ |
| title | A Prospective, Open‐Label, Post Marketing Study of the Safety and Effectiveness of a Hyaluronic Acid and Calcium Hydroxyapatite Hybrid Injectable |
| topic | Journal of Cosmetic Dermatology |
| url | https://onlinelibrary.wiley.com/doi/10.1111/jocd.70430 |