FDA OKs Bellafill for acne-scar therapy

The Food and Drug Administration has approved Bellafill (Suneva Medical) for the treatment of acne scars, making the product the first dermal filler to win the agency’s approval for that indication.

The approval was based on results of a placebo-controlled study at 10 clinical centers. According to a Suneva news release, the study required a high threshold for success in which the primary effectiveness endpoint was proven superior for subjects treated with Bellafill compared with control at six months.

The researchers found that at six months, the response rate for Bellafill was 64 percent, as compared with 33 percent for placebo. Investigators defined “response” as at least 50 percent improvement in treated acne scars as measured by a four-point Acne Scar Rating Scale (ASRS). At 12 months, Bellafill registered a response rate of 71 percent as measured by an unblinded assessment.

The study also assessed secondary effectiveness, as investigators and subjects both evaluated appearance on a Global Aesthetic Improvement Scale that was blinded through six months and unblinded at 12. Both groups rated appearance as improved, a measure that reached statistical significance at every time point after the week-four touch-up period and through the six-month follow-up. At that point, 84 percent of subjects were rated as improved based on the Physician Global Aesthetic Improvement Scale (PGAIS) and 98 percent at the 12-month unblinded assessment.

On the Subject Global Aesthetic Improvement Scale (SGAIS), 77 percent of the subjects rated their appearance as improved at six, 83 percent 12 months. Finally, subjects were asked to rate their level of satisfaction on a Subject Assessment of Scar Correction scale (SASC). At the six-month blinded assessment, 84 percent of the subjects said they were satisfied - that figure rose to 90 percent at the 12-month unblinded evaluation.

Suneva chairman and C.E.O. Nicholas L. Teti Jr. says he thinks the FDA’s approval of Bellafill marks a milestone for acne sufferers seeking an effective treatment not only for physical scars, but the emotional scars associated with acne.

“Forty to 50 million Americans have acne, and a significant number of them - as many as 90 percent, by some statistics - develop acne scars,” Mr. Teti tells Dermatology Times. “These scars are more than skin-deep - people who have them frequently have a very negative perception of themselves. Acne scars can take a real emotional toll, and we think the approval of Bellafill addresses a largely unmet need for people with acne.”

A Suneva news release cites an independent study that supports Mr. Teti’s observations about acne’s potential non-physical effects. In that study, more than 70 percent of respondents said their acne scars negatively impacted their self-confidence; 92 percent said they felt their self-confidence would be restored or improved if their scars were healed.

Mr. Teti adds that Benafill has the advantage of being long-acting: “Bellafill is classified as a permanent filler - it’s basically a one-time treatment.”  

Bellafill was originally called ArteFill. The dermal filler is comprised of 80 percent purified bovine collagen with 20 percent polymethylmethacrylate (PMMA) microspheres, and lidocaine. The company says it was rebranded in the United States “to reflect the transformational outcomes this unique product can provide to patients seeking correction of their acne scars and nasolabial folds.”