A 12-Month Follow-up, Randomized Comparison of Effectiveness and Safety of Two Hyaluronic Acid Fillers for Treatment of Severe Nasolabial Folds

Abstract

BACKGROUND Hyaluronic acid (HA) filler injection is an increasingly popular aesthetic procedure. OBJECTIVE To compare the effectiveness and safety of two HA fillers (HA ED and HA PER ) for the treatment of severe nasolabial folds (NLFs). MATERIALS AND METHODS This was an evaluator-blinded and subject-blinded split-face study. At baseline, HA ED or HA PER was randomly assigned to the left or right NLF. The follow-up period was 12 months. Effectiveness was assessed using the wrinkle severity rating scale (WSRS) and subject preference. Safety was assessed by adverse events and local tolerability symptoms recorded by subjects during 3 weeks after the treatment. RESULTS At 6 months, HA ED was noninferior to HA PER (assessed by mean change from baseline in WSRS score). There was a significant difference in mean WSRS score change from baseline in favor of HA ED at 3 to 12 months, and a majority of subjects preferred HA ED over HA PER at 12 months. However, the overall responder rate was similar between products, and it remained high throughout the study. At 12 months, approximately 80% of subjects were still responders. Both products were well tolerated and associated with a few treatment-related adverse events. CONCLUSION To conclude, HA ED was at least as effective and well tolerated for the treatment of severe NLFs as HA PER .