Portrait Plasma Receives Clearance From FDA To Treat Acne Scars
Rhytec has received FDA clearance to market a new indication for treating acne scars. Portrait Plasma is already cleared by the FDA for treating facial and non-facial areas for wrinkles, superficial skin lesions, actinic keratosis, seborrhoeic keratosis and viral papillomata.
An initial single site clinical study treating acne scars was conducted using the Portrait PSR3 plasma system. M. Potter, et al, evaluated 9 patients after one Portrait Plasma treatment and found acne scarring improved by 23% at six months and sustained for two years. Although this sample size was limited, an objective evaluation method was used as compared to the subjective methods (visual observation) used in most other studies. Silicone elastomer molds were made of the skin irregularities before and after treatment and compared by measuring the depth of the defects. A 35% decrease in acne scar depth was found in this elastomer evaluation (Potter et al. Annals of Plastic Surgery. Volume 58, Number 6, June 2007).
Rhytec then conducted a multi-center IRB clinical study at three sites evaluating Portrait Plasma treatment of areas of sunken, atrophic, post acne scars (G. Lask/P. Yamauchi, J.F. Tremblay & N. Uebelhoer). Twenty-nine patients completed the one treatment protocol with physicians reporting a mean improvement of 29% in acne scar appearance at 6 months. Patient self assessment was 35% average improvement and seventy-one percent (71%) of patients would recommend the procedure to a friend. These results were obtained after a single Portrait Plasma treatment compared to the six treatments patients endure with the 1320 nm Nd:Yag and up to 5 treatments with fractional lasers.