Efficacy and safety of porcine collagen filler for nasolabial fold correction in Asians: a prospective multicenter, 12 months follow-up study.

Recently, injectable dermal fillers have become important alternatives to surgical procedures for the correction of facial wrinkles. Bovine collagen is the first approved material for filler injection, and several studies have shown its efficacy. However, the risk of developing an allergic reaction and xenogenic transmission of bovine spongiform encephalopathy remain among its disadvantages. In this randomized, double-blinded, split-face study, we compared the efficacy and safety of a porcine collagen filler (TheraFill®) with that of a bovine collagen filler (KOKEN®) for nasolabial fold correction. A total of sixty one patients with mild to severe nasolabial fold were randomized to receive TheraFill® and KOKEN® on contralateral sides of the face. During the 12-month follow-up period, improvement in the Wrinkle-Severity Rating Scale score was slightly higher in TheraFill® group than KOKEN® group, although the difference was not statistically significant. No serious adverse reactions were observed and both materials were tolerable in most cases. In conclusion, the long-term effect of TheraFill® on nasolabial fold correction was comparable to that of KOKEN®, and it may be a good alternative to bovine collagen filler.

RCT Entities:   Population Interventions Outcomes