The Federal Drug Administration (FDA) approved a new treatment for wrinkles called laViv during the summer that involves a treatment plan with cell therapy using a person’s own cells for the injections. The treatment won approval from the FDA in June, 2011 after two successful trial treatments using 421 subjects.
The new treatment, laViv, has fewer side effects than Botox and no side effects that would cause permanent damage. The series of injections provide up to six months of smoother skin, giving a more youthful appearance. Some trial participants reported results lasting much longer.
What is laViv?
laViv is a skin cell treatment that injects a person’s own skin cells into the area around the mouth where lines commonly form during the natural process of aging. The skin cells used in the injections are retrieved from behind the ear. These skin cells are called fibroblasts and have the ability to make collagen naturally. The fibroblasts are sent to laViv’s laboratory to “grow.” This process allows for the fibroblasts to multiply the cell cultures to be used in the injections. The growing process takes from 11 to 22 weeks.
After the growing process at the laboratory, the fibroblasts are sent back to your doctor for injections. The injections are made in the nasolabial folds, which are commonly called the “frown or smile lines” around the mouth area. laViv’s treatment plan calls for three injections, one injection every five weeks.
Side Effects
Side effects are minimal and include redness, swelling, bruising, bleeding and pain at the injection site. Compared to the popular alternative, Botox, the new laViv treatment sounds like a good deal and one that more people would be open to using.
Botox has been known to cause permanent damage to some people’s skin because it freezes the muscles in and around the injection site. This results in some people having a very odd look, over shiny foreheads, or just a plain look from the lack of ability to show emotions when smiling.
The Trial Results
The trials for laViv consisted of 421 people in two separate studies. The subjects in the trial were injected with laViv three times or a placebo for which the subjects of the study and the doctor administering the trial did not know which subjects got the laViv and which subjects received the placebo. The results were studied six months after the third injection was received.
In the first study 57 percent of the participants in the group receiving the laViv treatment thought that the appearance of fine lines and wrinkles around their mouth improved. In the control group receiving the placebo, 33 percent of participants said they had improvement in their skin.
The doctor’s evaluations were more critical giving only 33 percent of patients receiving laViv the nod and only 18 percent in the group that did not receive laViv, but a placebo.
The second study showed 45 percent receiving the treatment and 18 percent in placebo group showing improvement in skin quality around the mouth.
While this isn’t a 100% fix, it is an improvement and celebrities along with the wealthy, will be open to this treatment since it doesn’t cause the problems associated with Botox.
How Much Does laViv Cost?
The company that developed laViv, Fibrocell Science of Exton, Pa has not announced a set price for the treatment, however, a spokesman for the company said the price is expected to be between $1,000 to $2,000 to create the cell bank. Treatment sessions are estimated to be $300 to $500 per treatment.
With FDA’a approval, people that just have to have a more youthful appearance will be choosing laViv over Botox because of fewer side effects and none that will cause permanent damage to muscles.
Sources:
The New York Times
Mail Online