Artecoll, an injectable wrinkle filler composed of polymethylmethacrylate microspheres and bovine collagen, is widely available outside the United States. For domestic availability, a multicenter Investigational Device Exemption study was required by the U.S. Food and Drug Administration. This study consisted of 251 subjects at eight centers who received injections of Artecoll or the currently approved collagen dermal filler (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 rating, and subject satisfaction rating data were collected at 1, 3, and 6 months. The safety data, measured as adverse events and immunoglobulin G 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 with collagen at 6 months (p < 0.001). At 6 months, the investigator success ratings and the subject satisfaction ratings for each of the four injections sites were superior for Artecoll (p < 0.001). In the Artecoll group, 12-month follow-up was obtained for 111 subjects (86.7 percent) and showed persistence of significant augmentation. Artecoll had fewer adverse events reported throughout the 12-month safety study period than the control group did in 6 months, although the difference was not statistically significant.
San Diego, Calif.
From the Division of Plastic Surgery, University of California.
Received for publication May 19, 2003; revised November 5, 2003.
Presented in part at the 52nd Annual Meeting of the California Society of Plastic Surgeons, in Rancho Mirage, California, May 25, 2002.
Dr. Cohen and Dr. Holmes are consultants to Artes Medical, San Diego, California.
Steven R. Cohen, M.D., 8010 Frost Street, Suite 412, San Diego, Calif. 92123, firstname.lastname@example.org