Purpose: Artecoll, an injectible wrinkle filler composed of polymethylmethacrylate microspheres and bovine collagen, is widely available outside the U.S. For domestic availability a multicenter IDE study was required by the FDA. Methods: The study consisted of 251 patients at 8 centers who received injections of Artecoll or collagen (control) in 1334 wrinkles of the glabella, nasolabial fold, radial upper lip lines and corner of the mouth lines. The treatments were randomized and follow up safety, efficacy, investigator success ratings, and patient satisfaction ratings data were collected at 1, 3, 6 and 12 months. Results: The safety data, measured as adverse events and IgG serum levels, were low and similar for both groups. The efficacy data, measured by masked observers using a photographic facial fold assessment scale, demonstrated a combined significant improvement with Artecoll compared to collagen at 6 months (p<.001). At 6 months the investigator success ratings and the patient satisfaction ratings in each of the 4 injections sites were superior for Artecoll (p<.001). In the Artecoll group, 12-month follow-up was obtained in 111 patients (86.7%). Artecoll had fewer adverse events reported throughout the 12 month safety study period. Collagen patients were not followed for efficacy at twelve months unless they converted over to Artecoll. Therefore, the Artecoll result at twelve months was compared to the Collagen group at 6 months. These results parallel the group differences observed at six months. Specifically, the 12-month Artecoll results showed significantly greater improvement thant the 6-month Collagen result for masked observer ratings of Nasolabial folds. The other areas showed no significant treatment differences between groups. Conclusions: Artecoll appears to be safe and effective up to 12 months following augmentation of facial wrinkles.