Arte Fill - FDA Testing

FDA Testing

Artefill was approved by the FDA in October 2006 based on data from a 12-month controlled, randomized, double-blind, clinical trial conducted at medical centers throughout the U.S.A. The study compared outcomes for patients treated with Artefill with those of patients treated with the bovine collagen dermal fillers Zyderm and Zyplast. A total of 251 subjects were enrolled and had either Artefill or the collagen control injected to treat their facial wrinkles. When evaluated 6 months after injection, which was the primary evaluation period, the wrinkle correction persisted in patients treated with Artefill compared to the wrinkle correction in the patients treated with the collagen control, who returned to their pre-treatment status. The Artefill patients were also evaluated one year after treatment, and demonstrated continued safety and wrinkle correction as compared to baseline and 6 months. The dermal filler products used as controls had lost efficacy by 6 months. A follow-up study of Artefill treated patients from this pivotal trial who were evaluated after a 5-year period has recently been completed. Wrinkle ratings for these patients at five years were compared to baseline and six months after treatment. The results showed continued and improved wrinkle correction at five years and demonstrated a similar safety profile to the pivotal trial, and the data have been published .

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