A Randomized, Evaluator-Blinded, Split-Face Comparison Study of the Efficacy and Safety of a Novel Mannitol Containing Monophasic Hyaluronic Acid Dermal Filler for the Treatment of Moderate to Severe Nasolabial Folds

Mannitol containing monophasic filler with higher crosslinking has not been well studied for moderate and severe nasolabial fold (NLF) correction. To compare the efficacy and safety of a novel mannitol containing hyaluronic acid (HA) filler (HA-G) with biphasic HA filler (HA-P) for moderate and severe NLF correction. Thirteen subjects with symmetric moderate to severe NLF received HA-G (in one NLF) and HA-P (in other NLF) and were evaluated for 24 weeks. At both 12 and 24 weeks, the mean improvement in Genzyme 6-point grading scale from baseline was significantly greater in the side of face that was treated with HA-G than HA-P (1.96±0.91 vs. 1.54±0.73 at week 12; p=0.044, 1.88±0.78 vs. 1.3±0.79 at week 24; p=0.027, respectively). At 12 weeks, the mean Global Aesthetic Improvement Scale score was 2.92±0.93 for HA-G and 2.31±0.95 for HA-P (p=0.008). Both fillers were well tolerated. The HA filler HA-G provides better efficacy and similar local tolerability compared with HA-P in 6 months following treatment for moderate and severe NLF.