Interim results from a five-year safety and patient satisfaction study on Artefill, a dermal filler used to correct nasolabial fold (NLF) or smile lines, are positive. Photo Credit: MicrosoftFebruary 22, 2010, (Sawf News) - Interim results from a five-year safety and patient satisfaction study on Artefill, a dermal filler used to correct nasolabial fold (NLF) or smile lines, are positive.
Results from the 18-month interim study were presented at the Skin Disease Education Foundation's 34th Annual "Hawaii Dermatology Seminar" in Waikoloa, Hawaii February 14-19th by Christopher B. Zachary, MBBS, FRCP, Professor and Chair, Department of Dermatology, University of California, Irvine.
The data collected thus far show Artefill to be safe and long lasting.
Artefill is marketed by Suneva Medical, a San Diego, CA, based privately-held aesthetic medical device company.
It's long lasting dermal filler that is not completely reabsorbed by the body, unlike other hyaluronic acid or collagen based dermal fillers.
Artefill is FDA approved and contains a combination of purified bovine collagen and microspheres that provide support to your skin.
While the collagen is reabsorbed by the body the microspheres remain in place to provide the support your own skin needs for long-lasting wrinkle correction.
As with other dermal fillers, the results of Artefill treatment are near instantaneous.
To insure you are not allergic to the collagen or anesthetic in Artefill, a skin test must be administered by your physician prior to the initial treatment or approximately four weeks ahead of time.
You can expect mild swelling and reddening at the treatment site. These side effects are usually gone within 24 hours.
The cost of ArteFill typically runs between $500 and $700 per injection.
The 23-center, prospective, open-label study underway to study the safety and efficacy of Artefill involves 1,008 patients who had 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 and satisfaction data are reported by all patients at 2, 6, 12, 18, 24, 36, 48 and 60 months to assess the presence of or absence of adverse events, patient satisfaction, and any changes in health.
Potential subject-reported AEs were followed up on 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.
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