New Acne Treatment Approved

Suneva Medical, Inc., announced The US Food and Drug Administration (FDA) has approved a novel acne scar treatment, Bellafill, the sole dermal filler currently on the market to aid the marring skin condition.

Researchers conducted a double-blinded, randomized, placebo-controlled pivotal study treating patients with Bellafill in 10 US clinical centers. Bellafill has now been proven to be safe and effective for the correction of moderate to severe facial acne scars on the cheek in patients over the age of 21 years, compared to subjects treated with a control saline injection.

The study required a high threshold for success in which the primary effectiveness endpoint was proven superior for subjects treated with Bellafill compared to the control group at 6 months. A responder was defined as a subject who had 50% or more of treated acne scars improve by 2 or more points on a validated 4-point Acne Scar Rating Scale (ASRS).

According to Nicholas L. Teti, Jr, Chairman and Chief Executive Officer at Suneva Medical, “These types of acne scars affect millions of people and can have a profoundly negative impact on their self-esteem and self-confidence. 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.”

Bellafill is reported to add volume to the skin to smooth out uneven acne scars to the level of the surrounding skin. The long-lasting treatment is a simple, in-office procedure with minimal downtime.

The procedure is expected to cost approximately $1,000 per injection, and like most cosmetic procedures, is not covered by insurance, according to Jeffrey Salomon, MD, Assistant Clinical Professor of Plastic Surgery at Yale University School of Medicine.

“With Bellafill, we have a tremendous opportunity to remedy acne scars and help patients live a happier, healthy life. The level of acne scar correction Bellafill achieves is truly impressive and I greatly look forward to using this proven treatment option with patients, “said Ava Shamban, PhD, Assistant Clinical Professor of Dermatology at the University of California, LA.