A promising new treatment for acne scars
The FDA announced last week that it has approved Bellafill, an injectable filler, for the treatment of moderate to severe acne scars on the cheeks of those over 21. Acne is the most common skin disorder in the U.S., affecting more than 40 million people, and this is potentially big news for people with severe cases or lingering scars. "This is ideal for patients who have not responded to topical therapy, like Retin-A, which takes months and only improves very superficial scars; those who do not want to go through a series of five chemical peels; or those who have only a few scars," says Valerie D. Callender, an associate professor of dermatology at Howard University College of Medicine in Washington, D.C., who was part of the team of investigators who studied the injectable's safety and efficacy. "If done properly, most patients will require only one or two treatments. And it's permanent."
Bellafill incorporates both collagen and polymethylmethacrylate (PMMA) microspheres. The collagen provides immediate volume and lift. Over time, it's absorbed by the body, while the microspheres remain as filler. In a study of the filler on patients with acne, 85 percent of 147 subjects rated their appearance as improved at six months, and 90 percent were satisfied at 12 months.
A filler that used a combination of collagen and PMMA has been around for more than a decade and was first introduced in Europe. Early problems resulted because the spheres were not uniform in shape, and it was reformulated with uniform spheres. A second controversy arose because the collagen was originally sourced from a herd of European cows. After a mad-cow scare there, the collagen source became-and remains, in the case of Bellafill-a closed herd in the United States (2 to 3 percent of the population has an allergy to bovine collagen, so prospective patients must have a patch test on their arm a month before getting the injection).
For the past eight years, the FDA-approved version of this injectable was called ArteFill, and it was officially cleared as a permanent filler for nasolabial folds, a.k.a. smile lines. Some patients loved it, and some complained about lumps and cysts, which were most likely due to off-label use in lips and under the eyes or because it was injected by practitioners who were not well trained in its use. (Lumps and bumps at the treatment site are a possible side effect of many injectable fillers.) With temporary fillers, such as hyaluronic acid, if the patient doesn't like the effect or has an adverse reaction to the formula, the gel can be dissolved instantly with injections of something called hyaluronidase. But unsurprisingly, a permanent filler is much harder to get rid of if problems arise. The formula seems to work best in smaller quantities and in less mobile, more static areas of the face, like the cheeks-the area for which the newly rechristened Bellafill is approved.
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