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A 12-Month Study to Evaluate Safety and Efficacy of Polymethylmethacrylate-Collagen Gel for Correction of Midface Volume Loss Using a Blunt Cannula as Measured by 3-D Imaging.

BACKGROUND
Although polymethylmethacrylate (PMMA)-collagen gel is approved for correction of nasolabial folds, there are no reports characterizing safety and efficacy in the midface, an area where fillers are often used in clinical practice.


OBJECTIVE
To determine the safety and efficacy of PMMA-collagen gel for long-term volume restoration in the midface.


METHODS
In this prospective, single-center, 12-month study, 23 subjects with a pretreatment Midface Volume Deficit Scale (MFVDS) grade of 3, 4, or 5 were treated with PMMA-collagen gel. Efficacy was measured by the investigator and blinded reviewers using the MFVDS at 3, 6, and 12 months. Subject Global Aesthetic Improvement Scale (SGAIS) and physician GAIS (PGAIS) ratings were collected at 3, 6, and 12 months.


RESULTS
Improvement in the MFVDS score from baseline was significant at all post-treatment time points (p < .0001). All subjects with baseline MFVDS grades of 5 (severe) or 4 (significant) had a grade of 0 (none) or 1 (minimal) at 12 months. Subject GAIS (SGAIS) and PGAIS ratings of improved or much improved were 100% at Month 3 and were maintained at 12 months (PGAIS = 100%, SGAIS = 91.3%). All adverse events were minor.


CONCLUSION
Polymethylmethacrylate-collagen gel is safe and effective for long-lasting correction of midface volume deficit.