The US Food and Drug Administration has given its nod to Bellafill® for the treatment of acne scars.
Suneva Medical Inc’s Bellafill is the only filler on the US market approved for the correction of of moderate to severe, atrophic, distensible facial acne scars on the cheek in patients older than 21.
“As the only filler on the market that is FDA-approved for the correction of acne scars, individuals now have new hope, and the simple procedure can help improve a person’s quality of life with minimal to no downtime.” —John Joseph, MD
The FDA approval of Bellafill was based on a double-blinded, randomized, placebo-controlled study in which subjects were treated with Bellafill or a control saline injection at 10 US clinical centers. The primary effectiveness endpoint was proven superior among subjects treated with Bellafill compared to control patients at 6 months. Response was defined as an improvement of two or more points on a validated four-point Acne Scar Rating Scale affecting 50% or more of treated acne scars. At 6 months, the response rate for Bellafill was 64% versus 33% for control (p=.0005). Bellafill continued to show effectiveness by an unblinded assessment at 12 months (71%), the study showed.
Both investigators and subjects were asked to evaluate appearance on a Global Aesthetic Improvement Scale that was blinded through 6 months and unblinded at 12 months. Both groups rated appearance as improved, reaching statistical significance at every time point after the touch-up period (at week 4) through 6 months. On the Physician Global Aesthetic Improvement Scale, 84% of subjects were rated as improved at 6 months and 98% were improved at 12 months by an unblinded assessment. On the Subject Global Aesthetic Improvement Scale, 77% of subjects rated their appearance as improved at 6 months and 83% rated their appearance as improved at 12 months. In addition, subjects were asked to rate their level of satisfaction with acne scar correction treatment on a Subject Assessment of Scar Correction scale. At 6 months (blinded), 84% of subjects were satisfied while 90% were satisfied at 12 months (unblinded).
Lasting Results
“The FDA-approval of Bellafill … presents a tremendous new treatment option for those with acne scarring, a widespread skin condition that, until now, has experienced an unmet clinical need,” says John Joseph, MD, a facial plastic surgeon in Beverly Hills, Calif, and an assistant clinical professor at the University of California, Los Angeles. “As the only filler on the market that is FDA-approved for the correction of acne scars, individuals now have new hope, and the simple procedure can help improve a person’s quality of life with minimal to no downtime.” Joseph was one of the clinical investigators on the study that led to Bellafill’s FDA approval for acne scars.
Previously, acne scars were often treated with subcision and dermal fillers with temporary, mediocre results and/or fractional Co2 laser resurfacing. “In my experience, nothing has been as efficacious as Bellafill for correcting moderate to severe, atrophic, distensible facial acne scars. Bellafill is uniquely suited for treating scars given its ability to support lasting collagen,” he says. “The collagen gel in Bellafill provides immediate volume and lift and, over time, the collagen is absorbed by the body. Furthermore, the polymethyl-methacrylate microspheres remain in place and create a matrix that provides structural support to the skin for lasting correction.”
As to how Bellafill will fit in with existing therapies, Joseph says, “in the future, we may see more multimodality treatments. To date, there have been no published studies describing the use of Bellafill in combination with other therapies for the treatment of acne scars.”
