LAVIV™ (azficel-T) can help improve the appearance of moderate-to-severe nasolabial folds, according to new research in Dermatologic Surgery.
LAVIV uses a patient’s own fibroblast cells to create a personalized filler. It is the first and only personalized cell therapy approved by the FDA for aesthetic use.
LAVIV is now available in major metropolitan areas throughout the US exclusively through board-certified dermatologists and plastic surgeons that have been trained by Fibrocell Science on the treatment process.
The new study included the combined results of two Phase III, multi-center, studies of 421 patients showing statistically significant efficacy results for LAVIV. When these results were taken together, 30 percent of participants 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 percent for placebo. In self-assessments, 59 percent of patients reported a two-point improvement six months after completing treatment, versus 26 percent among those who received placebo injections. The 2-point improvement by injector and self assessment was predefined as criteria for success in the studies. The most common adverse events were mild to moderate injection site reactions.
“This large, comprehensive study included strict criteria for demonstrating improvement in the appearance of moderate to severe smile line wrinkles,” says study author Stacy R. Smith, MD, an associate clinical professor in the division of dermatology at the University of California, San Diego, in a press release. “LAVIV is the first personalized cell therapy for aesthetic improvement to show a statistically significant benefit in large, controlled trials.”
[Source: Dermatologic Surgery]