San Diego — There are encouraging 18-month interim results from a prospective five-year safety and patient-satisfaction study on Artefill (collagen gel/polymethylmethacrylate, Suneva Medical) for use in correcting nasolabial folds, PR Newswire reports.
The interim results were presented by Christopher B. Zachary, M.D., professor and chairman, department of dermatology, University of California, Irvine, at the Skin Disease Education Foundation’s 34th Annual Hawaii Dermatology Seminar in Waikoloa, Hawaii, in February.
The 23-center study involved 1,008 patients with no recent history of nasolabial fold correction. Patients received an initial treatment with Artefill, and up to two touch-ups after 30 and 60 days, until full correction was achieved.
Potential adverse events (AE) and satisfaction data are reported by all patients at two, six, 12, 18, 24, 36, 48 and 60 months to assess any adverse events, patient satisfaction and changes in health. Potential subject-reported AEs were followed up, and changes thought to be granulomas were biopsied and confirmed or ruled out by histology. All study patients will complete a final in-office visit at 60 months.
PR Newswire quotes Dr. Zachary as saying, “The safety data presented at the Hawaii Dermatology Seminar should give aesthetic physicians some long-awaited encouragement to view Artefill on its merits as a safe and long-lasting dermal filler. My own experience with Artefill as both a clinical investigator in the open-label, long-term safety study and as a commercial user has been very positive.”
