(+) Breakthrough treatment for acne scars with Laviv skin cell cloning therapy and miXto SX fractional skin laser (PRWeb) - Apr 16, 2012 - P2/3, N=120; IT-A-008; Fibrocell Science announced the first scientific presentation of data demonstrating the efficacy of Laviv in treating moderate-to-severe depressed acne scars; The data were presented at the American Society for Dermatologic Surgery (ASDS) annual meeting in Washington, D.C; The study successfully met its two prospectively defined co-primary endpoints; According to the study results, a 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 pts (43.1% vs. 18.3%; p=0.000011) at the final assessment
P2/3 data • Fibrosis
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Shaft Medical San Diego, the area's premium aesthetic medicine practice providing the full range of advanced cosmetic procedures, announces the availability of LAVIV Combination Acne Scar Treatment California.
Shaft Medical San Diego is one of the first practices in California to introduce LAVIV, a revolutionary approach to California smoothing wrinkles and fading acne related scars. LAVIV uses the body’s own cells, called autologous cells, to rejuvenate skin, creating new collagen and boosting the scar-healing process. This means no allergic reaction risk, no injection of foreign substances, and best of all, fewer treatments necessary to achieve the client’s desired look, one that can last significantly longer than other injectable fillers.
LAVIV received FDA approval in June 2011 to treat the appearance of moderate to severe nasolabial fold wrinkles (smile lines) in adults. LAVIV can also be used to treat Crows Feet, Frown Lines, Nose to Mouth Lines and Stretch Marks.
LAVIV has other potential uses than the current FDA-approved indication of injection into the nasolabial folds. During development of the product several of the investigators noticed a marked improvement in acne scars. The proposed mechanism is that the fibroblastic activity re-contours the existing matrix of scar tissue.
The latest treatment breakthrough is to combine San Diego LAVIV and a proven noninvasive modality to break the scar tethers, such as MiXto SX Fractional Skin Resurfacing Laser, so that a significant improvement can be achieved in even the most difficult cases. A single MiXto SX treatment and a course of three monthly LAVIV injections is generally recommended. Improvements usually take a couple of months and are gradual.
Acne facts and combination treatment with San Diego LAVIV and MiXto SX
According to the American Academy of Dermatology, about 40 to 50 million Americans have acne at any one time. Rolling acne scars are caused by damage under the surface of the skin and appear as soft, saucer-like depressions or pits on the skin. The skin typically loses its underlying support and develops a wavy texture. The scars tend to be wide and shallow. Research shows that facial acne scarring is common and affects men and women equally, occurring to some degree in 95 percent of acne cases.
A recent multi-center, randomized, double-blind, placebo-controlled study demonstrated the efficacy of LAVIV (azficel-T) in treating rolling, moderate-to-severe depressed acne scars. Ninety-nine of the study patients received up to three injections with 2 mL autologous fibroblasts (10-20 million cells/mL) on one cheek and placebo (vehicle control; dye-free cell culture media) on the other at 14 day intervals. Treatment was administered at a dose of 0.1mL/cm2 into areas of acne scarring on the cheek, which were required have a scarred area of at least 9 cm-squared.
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 and patients at the time of final assessment conducted four months after completing the study treatment regimen. No subjects experienced serious adverse events, discontinued treatment, or withdrew from the study as a result of an adverse event.
Related
Recent study demonstrates Laviv (azficel-T) cell therapy effective in treating acne scars
http://www.shaftsandiego.com/newsandevents.php
Fibrocell Science, Inc. (OTCBB:FCSC.OB), an autologous cellular therapeutic company focused on the development of innovative products for aesthetic, medical and scientific applications, recently announced the first scientific presentation of data demonstrating the efficacy of LAVIV™ (azficel-T) in treating moderate-to-severe depressed acne scars. The data were presented at the American Society for Dermatologic Surgery (ASDS) annual meeting in Washington, D.C. 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.
According to the American Academy of Dermatology, about 40 to 50 million Americans have acne at any one time. Rolling acne scars are caused by damage under the surface of the skin and appear as soft, saucer-like depressions or pits on the skin. The skin typically loses its underlying support and develops a wavy texture. The scars tend to be wide and shallow. 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.
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.
All adverse events (AEs) reported during the study were mild or moderate in severity. No subjects experienced serious adverse events, discontinued treatment, or withdrew from the study as a result of an AE. The incidence of adverse events occurring in the treatment areas was comparable between LAVIV and placebo. The most common reported AEs were treatment area erythema (occurring in 11.1% of subjects) and swelling (occurring in 10.1% of subjects). Five of the 12 subjects reporting erythema and five of the 11 subjects reporting swelling had events of moderate severity in the LAVIV-treated area, whereas all treatment related AEs reported in the placebo-treated area were of mild severity. Other AEs reported during the study with a possible relationship to study treatment included bruising, rash, irritation, nodule, pain, acne, induration and headache. No clinically meaningful changes in vital signs or physical exam findings were reported.
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.
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