New LAVIV Data Potentially Offers a New Treatment Approach for Acne Scarring
Fibrocell is an autologous cellular therapeutic company focused on the development of innovative products for aesthetic, medical and scientific applications. Last week, Fibrocell Science announced their first scientific presentation of data demonstrating the efficacy of LAVIV™ (azficel-T) in treating moderate-to-severe depressed acne scars.
The patented technology behind LAVIV is an advanced process that extracts a person’s fibroblast cells from a small skin sample and multiplies them in the Fibrocell Science lab. In normal skin, fibroblasts are responsible for producing collagen. LAVIV is the resulting formulation of a person’s own fibroblast cells. Each person’s formulation of LAVIV is unique because it is made from their own cells.
The data was presented at the American Society for Dermatologic Surgery (ASDS) annual meeting in Washington, D.C. Highlights included:
- LAVIV, which is made from a person’s own collagen-producing skin cells, is the first and only personalized cell therapy approved by the FDA for aesthetic use and was recently approved for the improvement of the appearance of moderate-to-severe “smile line” wrinkles (nasolabial folds).
- LAVIV is being investigated for the treatment of rolling, depressed acne scars, but is not currently approved for this indication.
- Roughly 40 to 50 million Americans have had acne at some point in time.
- Research shows that facial acne scarring is common and affects men and women equally, occurring to some degree in 95 percent of acne cases.
In this study, LAVIV was injected into the facial acne scars of patients to smooth the skin depressions. The study successfully met its two prospectively defined co-primary endpoints:
- A 2-point or greater improvement on a 5-point Subject Live Acne Scarring assessment scale, and
- A 1-point or greater reduction in cheek acne severity on a physician-assessed, validated 5-point Evaluator Live Acne Scar assessment scale.
Final assessments were conducted four months after completing the study treatment regimen.
Gilly Munavalli, M.D. has been working with Fibrocell for some time now, and he is the Medical Director of Dermatology at Laser, and Vein Specialists of the Carolinas, and he is the Assistant Professor of Dermatology at Wake Forest University School of Medicine. Dr Munavalli was an investigator for the study, and he stated in the press release"
“Common approaches to treat acne scarring such as laser and fractional resurfacing can lead to prolonged downtime or unpredictable pigmentary complications of the skin. Our findings show that using a person’s own collagen-producing cells in the form of LAVIV may provide a promising new alternative to improve acne scarring with minimal downtime and an excellent safety profile.”
According to the study results, a statistically significant higher percentage of subjects responded to treatment with LAVIV than with placebo, as rated by both the study investigators (58.7% vs. 42.2%; p=0.016) and patients (43.1% vs. 18.3%; p=0.000011) at the final assessment. Patient and Evaluator assessments at earlier time points during the study also showed a statistically significant higher proportion of responses with LAVIV than with placebo at all but one assessment.
For additional information on the study, please visit www.fibrocellscience.com.