Clinical and histologic evaluation of a fractional radiofrequency treatment of wrinkles and skin texture with novel 1‐mm long ultra‐thin electrode pins

BACKGROUND: Fractional 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. OBJECTIVE: To 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 MATERIALS: This 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. RESULTS: Three 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. CONCLUSION: The 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.