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FDA Approves First Dermal Filler to Treat Acne Scarring
The FDA has given the nod to Bellafill (Suneva Medical, Inc.), a dermal filler, for the treatment of acne scars, making it the only product on the market with this indication.
Bellafill is made primarily of bovine collagen. When injected, it lifts and smooths pitted scars to the level of the surrounding skin. It is designed to treat moderate-to-severe acne scars on the cheeks of patients over the age of 21.
Acne is the most common skin disorder in the U.S., affecting 40 million to 50 million people. Up to 95% of people with acne may develop scarring.
The FDA’s decision was based on the results of a double-blind, randomized, placebo-controlled pivotal study in which subjects were treated with Bellafill at U.S. clinical centers. The product was found to be a safe and effective compared with a control saline injection.
At 6 months, the response rates for the Bellafill and control groups were 64% and 33%, respectively (P = 0.0005). A responder was defined as a subject who showed improvement in 50% or more of treated acne scars, as indicated by two or more points on a validated four-point Acne Scar Rating Scale (ASRS). Bellafill continued to show effectiveness by an unblinded assessment at 12 months (71%).
Both investigators and subjects were also asked to evaluate the appearance of treated scars on the Global Aesthetic Improvement Scale, which was blinded through 6 months and unblinded at 12 months. Both groups rated the appearance of treated scars 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 (PGAIS), 84% of subjects were rated as improved at 6 months, and 98% were improved at 12 months. Similarly, 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. The subjects were also asked to rate their level of satisfaction on a Subject Assessment of Scar Correction (SASC) scale. At 6 months (blinded), 84% of the subjects were satisfied, and 90% were satisfied at 12 months (unblinded).
The FDA cleared a laser treatment for acne scarring in July 2014, but adoption of this type of therapy is limited by its high cost, associated pain, and the need for repeat treatments.
Bellafill was initially approved in the U.S. in 2006 to smoothen “smile lines.” Pricing of the acne treatment is still being worked out, but it is likely to be similar to that of the wrinkle treatment at $2,500 for five syringes. Dosages would depend on the severity of the scarring.
The product launch is expected later this month.
Sources: Suneva Medical, Inc.; January 6, 2015; and Reuters; January 6, 2015.