Suneva Medical: Results positive in using dermal filler for acne scars
Suneva Medical has announced follow-up data from an investigational study that showed its dermal filler safely treated acne scars at 12 months.
“The effective treatment of acne scars represents a huge unmet clinical need,” researcher Pearl Grimes, MD, director of the Vitiligo & Pigmentation Institute of Southern California, said in a press release. “The results … were remarkable, and I look forward to the day when I can offer this treatment to my acne scar patients as an FDA-approved product.”
Treatment was shown to be “safe and well-tolerated,” according to the release. Adverse events with ArteFill, a dermal filler approved by the FDA in 2006 for treating nasolabial folds, were “expected, predominantly mild and resolved in a short period of time.”
Researchers currently are monitoring cross-over control participants from the study for 12-month safety. Upon result availability, Suneva said it plans to submit a pre-market approval supplement to the FDA for ArteFill’s use in treating atrophic facial scars, including acne scars.
The study met its primary endpoint at 6 months, a statistically significant higher response rate in scar correction for patients treated with ArteFill compared with those receiving saline, the release said.