Clinical and histologic evaluation of a fractional radiofrequencytreatment of wrinkles and skin texture with novel1-mm long ultra-thin electrode pins.

Abstract

BackgroundFractional radiofrequency (RF) microneedling technologies have shown effectiveness in treating skin laxity and wrinkles. We report the first experience using a novel device with 1‐mm long ultrathin electrodes that utilizes a smooth RF‐assisted ablation mode.ObjectiveTo evaluate the safety and effectiveness of treatment with a fractional RF device using 1.0‐mm long × 0.15‐mm diameter ultrathin electrode tips for improvement of facial skin texture and wrinkles.Methods and MaterialsThis was a prospective, open‐label, intraindividual‐controlled trial. Nine participants (mean age: 47.6, Fitzpatrick skin type II–IV, Fitzpatrick Elastosis Wrinkle Scale [FEWS] score: 3–6) underwent six treatment sessions with a fractional RF technology utilizing an array of 6 × 6 1‐mm long ultrathin electrodes. Treatment effectiveness was assessed by FEWS and the Global Aesthetic Improvement Scale (GAIS). Safety and tolerance were evaluated.ResultsThree months after the sixth treatment session, blinded, investigator‐assessed FEWS decreased from baseline 4.33 ± 0.67–3.33 ± 0.67 (p < 0.005); 88.9% of participants showed overall skin improvement using the physician‐assessed GAIS, and all of the participants reported improvement in skin texture and wrinkles. Treatment was well tolerated, with no adverse events and no downtime. Histological analysis in a porcine model showed a fractional pattern of epidermal ablation and dermal coagulation with intervening zones of normal healthy tissue. These changes were followed by progressive epithelialization over a period of 13 days.ConclusionThe fractional RF technology with the novel 1.0 long × 0.15 mm ultrathin electrodes tips was effective in improving skin texture and wrinkles without impacting the participants' daily activities.