Artecoll is not approved by the FDA U.S. Food and Drug Administration and is not available legally in the United States. A next generation product Artefill was approved by the FDA in December, 2006, to treat nasolabial folds with the added condition that a five-year follow up study of patients using must be done.
Before Artefill was approved by the U.S. FDA, it was studied in 251 subjects at eight medical centers in the United States. The subjects received injections in 1334 wrinkles of the glabella, the heavy wrinkles between the eyebrows, in the corner-of-the-mouth lines, in upper lips and in the nasolabial folds. A similar group of patients received injections of ordinary collagen (with the trade name Zyplast) in the same places in their faces.
Researchers then studied the patients’ improved appearance and the reactions of research subjects to the injections. At the six-month follow up, the researchers found the Artecoll group showed 86.7 percent better augmentation of loose skin than the group which received only collagen.