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news.Artes Medical, a medical aesthetics company, has completed enrollment in the 1,000-patient post-marketing study required by the FDA. The study follows patients treated with ArteFill, the first and only FDA-approved non-resorbable dermal filler, for a five-year period, the company said.
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The company reported that 1,000 study participants have now been screened and entered into the study which includes a skin test, ArteFill injections and follow-up evaluations for safety and duration of treatment effects of their facial wrinkles, known as nasolabial folds or smile lines.
All participants have been formally enrolled and skin tested with a few remaining participants scheduled to receive their Artefill injections within the coming weeks. Participants were enrolled at 23 dermatology and plastic surgery centers throughout the US.
Participants in this study will be assessed regarding long-term wrinkle correction and the safety profile of ArteFill over the five-year period. They will also be asked to rate their satisfaction with the treatment during this period. Treatment of the participants was done in accordance with the approved product labeling, and limited to the smile lines, which is the only indication approved by the FDA.
Christopher Reinhard, executive chairman of Artes Medical, said: “We are pleased to announce the completion of patient enrollment in this important post-marketing study with our final ArteFill commercialized formulation.
“In addition to assessing the safety and efficacy of ArteFill over a five-year period, this study provides us with an important opportunity to recruit key dermal filler opinion leaders from across the nation, increasing their familiarity with ArteFill and providing another pathway to deepen the use of ArteFill in clinical practice.”