Goals/Purpose: Decreased collagen production and loss of subcutaneous fat contribute to the development of facial aging. This pilot study is evaluates the local volumizing effects of an FDA-approved non-resorbable PMMA/bovine collagen filler (Suneva Medical) in the malar region of subjects with age-related volume loss
Methods/Technique: This multi-center, prospective, open-label study enrolled 24 subjects. Subjects received bilateral malar augmentation treatment with up to 2 “touch-ups” (day 0, 4 wk and 6 wk) until full correction was achieved (≤ 8.8 cc total). Injections were placed supraperiosteally. Subjects return at weeks 8, 26, 52, 104 and 260 for assessments. Baseline and post-treatment malar volume loss (5 point scale, 1=mild to 5=severe), investigator and subject global aesthetic improvement (GAIS, 5-point scale, 1+very much improved to 5=worst), safety data, and patient satisfaction and likelihood to recommend were collected.
Results/Complications: An interim analysis of available data from 23 subjects was completed at 6 months. At the time of the conference, data from 1 ˝ years of follow-up will be presented. The mean total volume injected was 5.35 ± 1.92 cc (range 2.4-8.8 cc). No device related AEs or SAEs were reported. Malar volume showed significant improvement of 1.18 ± 0.80 points (p < 0.0001). Physician assessed GAIS averaged 1.36 ± 0.58, while patient GAIS averaged 1.83 ± 0.83. 86.9% of patients were either satisfied with their treatment with 100% likely to recommend. Sequential photographs of patients across all visit timepoints will be presented.
Conclusion: Interim results (1 ˝ years of follow-up) of this long-term malar augmentation study suggests clinical utility, safety of use, and high patient satisfaction following treatment with this long-lasting PMMA dermal filler. Patients will continue to be followed out to 5 years.
