A Prospective 2-Year Extension Study to Evaluate the Safety and Effectiveness of PMMA-collagen Gel for the Correction of Mid-Facial Volume Loss.

Abstract

The safety and efficacy of polymethylmethacrylate (PMMA)-collagen gel for long-lasting correction of mid-face volume deficit was established for 12 months. To determine the long-term safety, efficacy, and durability of PMMA-collagen gel for midface volume restoration at 24 and 36 months. This prospective, single-center, 2-year extension study enrolled 22 patients treated with PMMA-collagen gel in the initial study. The primary endpoint was a 2-point improvement from baseline at 24 and 36 months on the Midface Volume Deficit Scale (MFVDS). Secondary endpoints included improvement from baseline to 24 and 36 months on the Physician- and Subject-rated Global Aesthetic Improvement Scales (PGAIS and SGAIS, respectively). The primary endpoint was met in 100% of the subjects, and the improvement in MFVDS score from baseline was significant at both 24 and 36 months (P<0.0001). PGAIS scores were rated as at least improved in 100% of subjects at 24 months and in 95% at 36 months. Similarly, 91% of participants at 24 months and 95% at 36 months reported enhanced appearance as measured by SGAIS. No additional adverse events were reported over the extension study. PMMA-collagen gel is a safe, effective, and durable treatment for restoring mid-face volume. J Drugs Dermatol. 2023;21(1): doi:10.36849/JDD.6966.