Suneva Medical, an aesthetic medical device company, has presented 18-month interim results from its five-year safety and patient satisfaction study on 'Artefill' for nasolabial fold (NLF) correction.
The company claims that the study assessed adverse events with Artefill starting at six-months post treatment. Initial results showed the incidence of adverse events with Artefill compare favorably to the current label, and that the majority of patients (88%) reported a high satisfaction rating. Upon completion, this will be the largest and longest duration prospective US clinical study of any dermal filler.
The 23-center, prospective, open-label study consists of 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, said the company.
Werschler, study investigator and assistant clinical professor in Medicine/Dermatology at University of Washington, said: “Our initial analysis is encouraging as it further validates Artefill’s strong safety profile and high level of patient satisfaction for long-term wrinkle correction. A granuloma incidence rate of less than 0.1% is also indicative of this and suggests Artefill is as safe as other dermal fillers, such as Juvederm and Restylane.”
Niv Caviar, president and chief executive officer of Suneva Medical, said: “These results are consistent with what we observed during the pivotal trial and further validate Artefill’s role as a long-lasting filler in the aesthetic market. We look forward to reporting additional interim results later this year as more patients reach the two-year point.”