Pivotal clinical trial data demonstrating the effectiveness of LAVIV (azficel-T) in the treatment of moderate-to-severe nasolabial fold wrinkles has been published by the Dermatologic Surgery journal (online, March 2012). The data includes the combined results of two identically designed, Phase III, multicenter, randomized, double-blind, placebo-controlled studies of 421 patients. The criteria for a positive response included a two-point improvement in the Subject Wrinkle Assessment Scale and a two-point improvement on the Evaluator Wrinkle Assessment Scale for both nasolabial folds. Based on this standard, 30% of subjects who received at least one LAVIV injection had a two-point improvement in the appearance of smile lines six months post-treatment—as rated by investigators—versus 8% for placebo. In self-assessments, 59% of subjects reported a two-point improvement six months post-treatment.
“The positive effects of LAVIV were maintained six months after the third injection,” says Girish (Gilly) Munavalli, MD, one of the study’s authors. “It was exciting to see that LAVIV showed no signs of degradation during this time and that the effect persisted. The efficacy of LAVIV beyond six months hasn’t been evaluated in adequate and well-controlled clinical trials.”
The researchers, led by Stacy R. Smith, MD, noted that the injections were well-tolerated. The most common adverse events included mild to moderate injection site reactions.