By Stacy R. Smith, MD
As if acne was not bad enough, up to 20 million Americans
will develop unsightly acne scars in its wake. While physicians currently rely on a variety of treatments, from laser resurfacing to chemical peels, there may be a new treatment option in the near future.
Group Endorses New Pediaric Acne Treatment Guidelines
The American Academy of Pediatrics is throwing its support behind pediatric acne management guidelines issued by the American Acne and Rosacea Society. According to the guidelines, mild acne often can be treated with over-the-counter washes, lotions, and products containing benzoyl peroxide. The next step could be topical retinoids like Retin-A and Differin. For moderate to severe acne, oral antibiotics are appropriate, but tetracycline derivatives should not be used in children younger than 8 years. If acne is severe and other treatments have failed, isotretinoin—brand names including Roaccutane (formerly known as Accutane) and Claravis—can be considered, with counseling to avoid pregnancy and close monitoring for other potential adverse events.
Many of us know ArteFill® as a long-lasting dermal filler for wrinkle correction of nasolabial folds, but it is currently being tested as a treatment for acne scars. ArteFill manufacturer Suneva Medical Inc is currently completing a pivotal trial looking at ArteFill for acne scars. It plans to submit the results to the federal Food and Drug Administration (FDA) for review and seek approval for the new indication.
As a physician involved in the randomized, double-blind, multicenter, controlled study, I witnessed the impressive results firsthand. The treatment successfully—and substantially—reduced the appearance of moderate-to-severe atrophic acne scars.
If approved, ArteFill will be the only dermal filler with an acne scar indication. It could provide a real benefit for patients who have been struggling with the physical and emotional effects of acne scarring.
More than 130 subjects were randomized (2:1 active to control) and completed treatment with ArteFill or saline control This study enrolled a greater proportion (40%) of male subjects than most filler studies. Additionally, approximately 25% of subjects treated had Fitzpatrick skin type V or VI, which is one of the largest percentages of darker skin types enrolled in any FDA filler study. Variety was a critical part of the study subject selection process, as acne scarring doesn’t discriminate between race, age, gender, or skin types.
All subjects had to be 18 years old or older, with no active acne, no prior fillers within specified time frames, and moderate to severe atrophic scars. Severity was rated using a proprietary scale that Suneva Medical developed and validated.
After skin testing, subjects underwent one injection session for all eligible scars. Most subjects underwent a touch-up injection 4 weeks following their first treatments based on their results. The effects were assessed by blinded evaluators.
Subjects treated with ArteFill demonstrated a statistically significant greater response rate relative to the control arm at 6 months, and as early as the first visit after complete treatment. For subjects to be counted as responders, they had to exhibit a two-point improvement on a four-point Acne Scar Response Scale (ASRS) for at least half of the scars treated.
Additionally, physicians and subjects both noted remarkably substantial improvements on a global aesthetic scale among subjects treated with ArteFill relative to the control group at 6 months. Subjects were also asked to rate their satisfaction using a Subject Assessment of Scar Correction. Those treated with ArteFill demonstrated a statistically significant higher degree of satisfaction at 6 months relative to the controls.
The interim adverse effects reported during the study were mild, consistent with other filler studies, and they all resolved promptly. There was no statistically significant difference in side effect rates between subjects treated with ArteFill versus those treated with placebo.
The study is ongoing. Subjects will be evaluated for safety at 1 year after the last ArteFill treatment. After the safety evaluations are completed, Suneva plans to submit a premarket approval supplement to the FDA seeking approval for the new indication.
Treating acne scars can be labor-intensive, requiring multiple visits, expensive equipment, and significant downtime—a big drawback when combined with the fact that current treatments are not always effective. The impact of ArteFill’s potential new indication—if approved—could be a real game-changer, as there is currently no good solution that provides lasting improvements or is widely available. It could help change patients’ physical appearance and, in turn, positively affect their self-esteem, confidence levels, and quality of life. n
|Stacy R. Smith, MD, is a board-certified dermatologist in Del Mar, Calif. He is an associate clinical professor in the Division of Dermatology at the University of California, San Diego. Smith can be reached via PSPeditor@allied360.com.|