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ArteFill (Suneva Medical) may fill a void in the long-term treatment of acne scarring, initial study data indicates.
ArteFill (Suneva Medical) may fill a void in the long-term treatment of acne scarring, initial study data indicates.
In an ongoing study being conducted by Suneva, patients whose acne scars were treated with ArteFill had a statistically significant improvement in appearance compared with a control group at as early as six weeks after treatment.
Researchers randomly assigned about 130 patients to receive treatment with ArteFill or saline. Treatment success was determined by at least half of a patient’s scars showing a two-point improvement on an Acne Scar Response Scale. Two-thirds of patients treated with ArteFill demonstrated this improvement compared with one-third of those in the control group, according to a news release.
Physicians and subjects reported statistically significant improvements in appearance in patients treated with ArteFill compared with the control group at six months. On a Subject Assessment of Scar Correction scale, patients treated with ArteFill demonstrated a statistically significant higher degree of satisfaction at six months compared with the control group.
Among the patients enrolled in the study, 40 percent were male. Additionally, 26 percent had Fitzpatrick skin types V or VI.
Researchers found no statistically significant difference in adverse event rates between groups at six months. Treatment-related adverse events were rare, mild and resolved, researchers reported.
The safety portion of the study will continue through the end of the year, at which time data will be submitted to the Food and Drug Administration with the goal of gaining approval for the treatment of acne scars, according to Suneva.