Artecoll: a long-lasting injectable wrinkle filler material: Report of a controlled, randomized, multicenter clinical trial of 251 subjects.

摘要: 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 U.S. Food Drug Administration. This consisted 251 subjects at eight centers who received injections Artecoll or currently approved collagen dermal (control) in 1334 wrinkles glabella, nasolabial fold, radial upper lip lines, corner-of-the-mouth lines. The treatments were randomized, follow-up safety, efficacy, investigator success rating, subject satisfaction rating data collected 1, 3, 6 months. safety data, measured as adverse events immunoglobulin G serum levels, low similar for both groups. efficacy masked observers using photographic facial fold assessment scale, demonstrated combined significant improvement with compared months (p < 0.001). At months, ratings each four sites superior In group, 12-month obtained 111 (86.7 percent) showed persistence augmentation. had fewer reported throughout period than control group did although difference not statistically significant.