Efficacy Data for LaViv Now Published
Data demonstrating that LaViv (azficel-T, Fibrocell Science, Inc.) is effective for the aesthetic improvement of moderate to severe smile lines are now published online in Dermatologic Surgery. The combined results of two identically-designed, Phase III, multi-center, randomized, double-blind, placebo-controlled, studies of 421 patients showed statistically significant efficacy results for LAVIV. The criteria for a positive response included a 2-point improvement on the Subject Wrinkle Assessment Scale and a 2-point improvement on the Evaluator Wrinkle Assessment Scale for both nasolabial fold wrinkles. LaViv, FDA-approved in June 2011 for the improvement of the appearance of moderate-to- severe nasolabial fold wrinkles in adults is the first and only personalized cell therapy approved by the FDA for aesthetic use and is now available in major metropolitan areas throughout the US. Analysis of the current data show that 30% of subjects who received at least one LaViv injection had a 2-point improvement in the appearance of smile lines six months after completing treatment, as rated by investigators, versus 8% for placebo. In self-assessments, 59% of patients reported a two-point improvement six months after completing treatment, versus 26% for placebo.