Artes Medical Inc last week announced that enrollment has been completed in the 1,000-patient postmarketing study required by the FDA. The study follows patients treated with the ArteFill nonresorbable dermal filler for a 5-year period.
The firm has reported that 1,000 study participants have 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 nasolabial folds.
Participants were enrolled at 23 dermatology and plastic surgery centers throughout the United States. The co-lead investigators are plastic surgeon Steven R. Cohen, MD, clinical professor, Division of Plastic Surgery, University of California, San Diego School of Medicine; and Rhoda S. Narins, MD, past president of the American Society of Dermatologic Surgery and clinical professor of dermatology at New York University Medical School.
Participants in this study will be assessed regarding long-term wrinkle correction and the safety profile of ArteFill over the 5-year period. They will also be asked to rate their satisfaction with the treatment during this period. In previous studies, patients have indicated very high levels of both short- and long-term satisfaction, with ratings of more than 90%, according to the company.
[Source: Artes Medical Inc]