Treatment of Age-related Mid-face Atrophy by Injection of Cohesive Polydensified Matrix Hyaluronic Acid Volumizer.

OBJECTIVE: Cohesive Polydensified Matrix® Hyaluronic Acid Volumizer is designed to be injected subcutaneously or in deeper soft tissue layers to restore facial volumes. This post-marketing clinical follow-up was performed to confirm the safety and effectiveness of the product up to 18 months.

DESIGN: Injections were performed according to standard clinical practice and patients were followed-up at Months 1, 3, 6, 9, 12, and optionally at Month 18. Effectiveness measures included facial volume loss scale, global aesthetic improvement scale and patients' satisfaction. Injection site reactions were recorded to evaluate safety.

RESULTS: Twenty patients with intermediate-to-severe volume loss in the lateral cheek hollows and/or cheekbone area were treated. Facial volume loss scale scores dropped significantly from a mean value of 3.1 at baseline to 1.3 at Day 1. Significant volume enhancement was maintained at each follow-up visit with mean scores ranging from 1.3 at Month 1 to 1.8 at Month 12. Investigators' global aesthetic improvement scale assessment showed that up to Month 6 at least 94 percent of patients were rated as "very much improved" or "much improved." At Month 9, all patients still showed a benefit of treatment with 81 percent rated as "very much" or "much improved" and 19 percent as "improved." Patients' evaluation was consistent with investigators' results. A few expected transient injection site reactions of mild-to-moderate intensity were reported immediately after treatment. These reactions were considered related to the injection procedure, rather than the product.

CONCLUSION: Cohesive Polydensified Matrix Hyaluronic Acid Volumizer is safe and effective for mid-face volume augmentation lasting up to Month 12 and most probably up to Month 18. The aesthetic effect was demonstrated by the effectiveness evaluations and high patient satisfaction.