Acne is the most common skin disorder in the US, affecting 40 to 50 million people.1 Furthermore, up to 95% of individuals with acne may develop scarring.2 As a result, patients often become depressed, self-conscious, and lack self-esteem. Our patients often feel they have tried everything to correct their acne scars—topical treatments, chemical peels, dermabrasion, microneedling, and both laser resurfacing and laser stimulation. These treatments may be associated with significant downtime, require many months of repeat treatments to see optimal results, and may lack rigorous, controlled data to support their safety and efficacy. The recent FDA approval of Suneva Medical Inc.’s Bellafill® for the treatment of acne scars has the potential to be a game changer.
It is the only filler on the US market approved for the correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in patients older than 21. This dermal filler immediately adds volume to the skin to lift acne scars, helping to recreate the skin’s own firmer structure for a more even contour of the skin. The long-lasting treatment—which is a simple, in-office procedure with minimal to no downtime—gives us a tremendous opportunity to correct acne scars and help patients overcome the negative psychological and physical effects associated with acne scarring.
Methods and Results
My practice, Dermatology Partners Inc in the Boston area, was one of the sites in the 10-center study that led to the FDA approval of Bellafill . The dermal filler was found to be a safe and effective treatment when compared to subjects treated with a Control 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 four-point Acne Scar Rating Scale. At 6 months, the response rate for Bellafill was 64% responders versus 33% responders for the Control (p=0.0005). Bellafill continued to show effectiveness by an unblinded assessment at 12 months (71%). The results held up in all types of patients, as there were no significant differences in effectiveness seen between male and female, lighter and darker skin types, or subjects older or younger than age 45.
Secondary effectiveness end points were also evaluated. 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 at 12 months (unblinded), 90% were satisfied.
The treatment was shown to be safe and well-tolerated through 12 months. There were few treatment-related adverse events. Those that occurred were predominantly mild and transient.
Conclusion and Clinical Pearls
For optimal treatment of acne scars, the ideal agent is one that restores volume, is precise, offers immediate results, is long-lasting, has minimal downtime, and is appropriate for all skin types. Bellafill uniquely fits these criteria. It combines 80% purified collagen and 20% polymethylmethacrylate (PMMA) microspheres to create a natural, lasting result.
The collagen gel in Bellafill provides immediate volume and lift and is gradually absorbed by the body. The PMMA microspheres remain in place and create a matrix that provides structural support to the skin for lasting correction—a win-win for patients who do not desire continued retreatments.
When injecting Bellafill for indicated acne scars, the correct placement of the needle is deep dermal to the subdermal junction. I’ve had success in some instances with subdermal placement.
With Bellafill®, physicians have access to a new, proven acne scar treatment that is easy to integrate within a practice. The level of acne scar correction Bellafill achieves is truly impressive. I’ve experienced firsthand the incredible improvements it offers to patients—on a physical and emotional level—and believe the dermal filler represents a transformational treatment that can make a real impact in your practice. The filler also opens a wider door for male patients who are equally affected as women by acne scarring.
Ruth Tedaldi, MD, is a dermatologist ?at Dermatology Partners Inc in the Boston area. She can be reached at PSPeditor@allied360.com.
1. American Academy of Dermatology. http://www.aad.org.
2. Layton et al. A clinical evaluation of acne scarring and its incidence. Clin Exp Dermatol. 1994;19:303-308.