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Home » Blog » FDA approves Bellafill® for Acne Scars

FDA approves Bellafill® for Acne Scars

Good news! For the past two years, I have been using Bellafill® (aka Artefill®) for treating acne scars, and the results have been excellent. Now, following a ground-breaking study, the FDA has announced their stamp of approval.

For those of you who have acne scars, but cannot afford the downtime following laser treatments, finally, there is another solution.  On January 6, 2015, Suneva Medical announced that the FDA has approved the dermal filler, Bellafill®, for the treatment of acne scarring.

Acne is the most common skin disorder in the U.S., affecting some 45 million people, 95% of whom may develop permanent scars from the disease. Because of it’s ability to stimulate the formation of collagen, Bellafill® has been proven to perform well for the correction of severe scarring. After extensive study, the FDA has approved its use for patients over the age of 21.

“These types of acne scars affect millions of people and can have a profoundly negative impact on self-esteem and self-confidence,” said Nicholas Teti, Chief Executive Officer at Suneva Medical. “The results of this rigorous clinical study prove that Bellafill® reduces the appearance of acne scars—providing a solution to this widespread skin condition that previously had limited treatment choices. Bellafill® can have a transformational effect on a patient’s appearance and in turn, we hope an improvement in quality of life.”

At first the product adds volume to the skin, helping to lift and smooth the scarred tissue.  Then, over time, the body reacts to the filler by creating natural collagen, giving the skin a natural pink color, and replacing some of the white, shiny scars.

“In the dermatology field, we regularly see patients who live with the burden of acne scarring—a physical and emotional trauma that leads many to feel depressed, less energetic and less social. With Bellafill®, we have a tremendous opportunity to remedy acne scars and help patients live a happier, healthy life”, said Dr. Ava Shamban, Assistant Clinical Professor of Dermatology at UCLA.

“Until Bellafill® arrived on the scene, the only truly effective options that I could offer at FreshSkin were limited to laser treatments,” said Dr. Josie Tenore of Highland Park, IL. “And while I consistently get beautiful results with our Sciton ProfractionalⓇ -XC Erbium laser, some of my patients just don’t want the post-treatment downtime. When I became a Suneva trainer, I learned all about their acne study and started treating acne scars with Bellafill®. My patients have been thrilled with the results, and I am thoroughly pleased to add this exceptional product to the FreshSkin menu of services.”

So, what exactly does the FDA approval mean?

In order to be granted FDA approval, a product must first achieve very high measures of both effectiveness and safety, within carefully designed studies that meet the highest scientific standards for objective rigor. The studies for Bellafill® were done at 10 U.S. clinical centers, where patients were divided into two groups—those being treated with Bellafill®, and a control group who were treated with saline.  Neither the patients nor the physicians knew which patients were in which group. The threshold for improvement was set very high, requiring at least 50% of scars to improve by at least two points on an Acne Scar Rating Scale. Both the physicians and the patients highly rated the improvement among patients in the Bellafill® group at both the 6-month and 12-month milestones.

So, if you have acne scarring and thought that laser treatment was your only option, FreshSkin in Highland Park, IL now offers a safe, effective and convenient alternative. Call 847-681-8821 to find out more!

 

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595 Elm Place, Suite 208
Highland Park, IL 60035
847-681-8821