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.
Portrait Plasma is a one of its kind - novel, non-invasive, in-office technology clinically proven to treat unhealthy signs of aging often accelerated by sun exposure and acne scars. Plasma treats 100% of the skin; it stimulates a natural response producing healthier regeneration of the skin. Different from lasers which only target specific components of the skin, physicians and patients feel that with plasma's unique approach results are maximized. This is especially important when treating acne scars, all wrinkles, skin laxity and pre-cancerous lesions, such as actinic keratosis. Further, unlike other procedures on the market, like CO2, erbium, or fractionated lasers, Portrait Plasma offers less downtime and little to no risk of hypopigmentation, scarring or discoloration as seen in this clinical study.
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