Dermal Filler Considered Safe Treatment for Individuals with Acne Scars
The privately-held aesthetics company Suneva Medical Inc., has recently announced the results of a follow-up study which took place 12 months after its original multi-center, randomized, double-blinded Pivotal acne scar study. The original study evaluated the efficacy and safety of the dermal filler ArteFill, which is used to treat acne scars. Study subjects were investigated 12 months after the original study, and the treatment was noted as being safe. Adverse side-effects which were related to the treatment were expected, and noted as being predominantly mild. Any side effects experienced were resolved within a short period of time.
The study is ongoing, and cross-over control subjects are in the process of being monitored after the original study took place 12 months ago. Once all data has been collated for all study groups, and safety has been fully evaluated, Suneva is planning to submit a new premarket approval supplement, or PMA, and hopes to receive approval from the Food Drug Administration, or FDA, for treatment of acne scars, a form of atrophic facial scar. This study was already noted as being efficacious six months after the original study had taken place. At this point, study subjects who had been treated with ArteFill had demonstrated a higher response rate in the amount of scar correction that other subjects who had been treated with saline control. Statistically, this was a significantly higher response rate.
Dr. Pearl Grimes, who was a principal investigator in the study, has noted how effective treatment of acne scars is a medical need which has still not been met. Grimes went on to note that the results from the study were “remarkable” and is looking forward to when this new acne scar treatment is approved by the Food and Drug Administration.
Nicholas L. Teti Jr., CEO and Chairman of Suneva Medical also noted that the results from the 12 month follow-up study were extremely positive and hopes that ArteFill can help to treat the millions of people who suffer from acne scars.
ArteFill was approved by the Food and Drug Administration back in 2006. The dermal filler was approved to correct smile lines, otherwise known as nasolabial folds.
To read more about ArteFill, click here.
About the company
Suneva Medical Inc., is a private company which focuses on the commercialization, development and manufacture of differentiated products intended for the aesthetic and general dermatology markets. The company is currently responsible for marketing ArteFill, which has been designed to help treat acne scars in patients, in the United States, Singapore, and Korea. The company is also responsible for marketing ReGenica Skincare in the United States, an advanced skin care program which consists of three different products designed to help restore skin and provide a more youthful experience. Suneva Medical Inc., also markets Bellafill in Canada, a long-lasting dermal filler that can help to provide natural-looking, safe, and immediate results for patients that last. If you have any other information about ArteFill, or the results from this recent study, please visit the official website of Suneva Medical Inc., at www.sunevamedical.com