Long-term dermal filler Bellafill (formerly Artefill) from Suneva Medical has received U.S. Food and Drug Administration (FDA) approval for the treatment of acne scars. In the double-blinded, randomized, placebo-controlled pivotal study, which included 10 U.S.-based clinical centers, Bellafill was shown to be safe and effective for the correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 when compared to subjects treated with saline injection.
A responder was defined as a subject who had 50% or more of treated acne scars improve by two or more points on a validated 4-point Acne Scar Rating Scale (ASRS). At six months, the response rate for Bellafill was 64% vs. 33% for the control group (p = 0.0005). Bellafill continued to show effectiveness by an unblinded assessment at 12 months (71%).
Investigators and subjects were asked to evaluate appearance on a Global Aesthetic Improvement Scale that was blinded through six 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 six months. On the Physician Global Aesthetic Improvement Scale (PGAIS) 84% of subjects were rated as improved at six months and 98% were improved at 12 months. On the Subject Global Aesthetic Improvement Scale (SGAIS), 77% of subjects rated their appearance as improved at six 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 (SASC). At six months, 84% of subjects were satisfied while 90% were satisfied at 12 months.
“These types of acne scars affect millions of people and can have a profoundly negative impact on their self-esteem and self-confidence,” said Nicholas L. Teti, Jr., chairman and CEO of 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.”