Suneva Medical, Inc., a privately-held aesthetics company, announced today that the U.S. Food and Drug Administration (FDA) has approved the dermal filler, Bellafill®, for the treatment of acne scars.
Bellafill® represents a significant clinical advancement as the only filler on the market approved for this disfiguring skin condition. Acne is the most common skin disorder in the U.S., affecting 40-50 million people1 and up to 95% of people with acne may go on to suffer from scarring.2 Bellafill® was studied extensively prior to its FDA approval and proven 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 years.
"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 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."
In an independent study, more than 70% of respondents felt their acne scars negatively impacted their self-confidence, with 92% indicating self-confidence would be restored or improved if their acne scars were healed.3 To help treat disfiguring acne scars, Bellafill® adds volume to the skin to lift and smooth out pitted acne scars to the level of the surrounding skin. The long-lasting treatment is a simple, in-office procedure with minimal to no downtime.
"In the dermatology field, we regularly see patients who live with the burden of acne scarring—a physical and emotional burden 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, and an investigator in the Bellafill® acne scar study. "The level of acne scar correction Bellafill® achieves is truly impressive and I greatly look forward to using this proven treatment option with patients."
Joana, a clinical study subject, expressed how treatment with Bellafill® has affected her: "Bellafill® has improved my skin, it has lifted it up … and I just feel more positive. I feel more secure about myself. I feel more beautiful going out on the streets and just mingling with people. I feel more confident."
Clinically and Statistically Significant Results
FDA approval of Bellafill® was based on the outcomes of a double-blinded, randomized, placebo-controlled pivotal study in which subjects were treated with Bellafill® at 10 U.S. clinical centers. Bellafill® was found to be a safe and effective treatment when 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 Control at 6 months. 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 6 months, the response rate for Bellafill was 64% vs. 33% for Control (p=.0005). Bellafill® continued to show effectiveness by an unblinded assessment at 12 months (71%).
Secondary effectiveness endpoints were evaluated, where 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 timepoint after the touch-up period (at week 4) through 6 months. On the Physician Global Aesthetic Improvement Scale (PGAIS) 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 (SGAIS), 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 (SASC). At 6 months (blinded), 84% of subjects were satisfied while 90% were satisfied at 12 months (unblinded).