Phase III Data for Laviv Demonstrates Efficacy and Good Safety Profile
Fibrocell Science, Inc., has released positive Phase III clinical trial data for Laviv (azficel-T), indicated for the treatment of moderate-to-severe nasolabial fold wrinkles.
Laviv uses a patient’s own cultured collagen-producing fibroblast cells that are then injected into nasolabial fold wrinkles. The new Phase III data was published in Dermatologic Surgery and combines the results of two multi-center, randomized, double blind, placebo-controlled studies of 421 patients. Based on the standard of a 2-point improvement in both patient and investigator wrinkle assessments, “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.”
“This large, comprehensive study included strict criteria for demonstrating improvement in the appearance of moderate-to-severe smile like wrinkles,” said Dr. Stacy R. Smith, associate clinical professor in the division of dermatology at UC San Diego and lead author of the paper in Dermatologic Surgery. “Laviv is the first personalized cell therapy for aesthetic improvement to show a statistically significant benefit in large, controlled trials.”
According to the press release from Fibrocell, Laviv demonstrated a good safety profile in the studies; the most common adverse events were mild to moderate injection site reactions.