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Waltham, Mass. - The Food and Drug Administration (FDA) has approved the Portrait (R) Plasma (Rhytec) for the treatments of acne scars, PRNewswire reports.
- The Food and Drug Administration (FDA) has approved the Portrait (R) Plasma (Rhytec) for a new indication; acne scars, PRNewswire reports.
An initial single site clinical study treating acne scars was performed, using the Portrait PSR3 plasma system. Researchers evaluated nine patients after one treatment, finding the acne scars improved by 23 percent at six months and sustained for two years. Patients were evaluated with visual observation as well as through silicone elastomer molds that were made of the skin irregularities before and after treatment and compared by measuring the depth of the scar. Researchers reported a 35 percent decrease in acne scar depth, PRNewswire reports.
Rhytec then conducted a multicenter IRB clinical study at three sites using the Portrait on 29 participants with sunken, atrophic, post-acne scars. Researchers found a 29 percnet improvement in acne scars at six months.
The thermal energy device is already FDA approved for the treatment of facial and nonfacial areas for wrinkles, superficial skin lesions, actinic keratosis, seborrheic keratolsis and viral papillomata, according to PRNewswire.