Abstract

Application of radiofrequency (RF) energy with microneedles to facial skin shown to promote skin renewal. To evaluate the safety and efficacy of the VoluDerm technology with 100 ultra-thin electrodes gen100 tip for improvement of skin texture and wrinkles. A prospective, open-label, intra-individual-controlled trial. Twelve subjects (mean age, 45.5; Fitzpatrick skin types II-III) with Fitzpatrick Elastosis Scale (FES) score 3-6 were treated with VoluDerm RF technology using the gen100 ultra-thin electrodes disposable tip. The participants underwent three treatments at 3-week intervals. Treatment safety was evaluated at each treatment visit and at the follow-up visits (1 and 3months post last treatment). Efficacy of treatment evaluated at 1 and 3months after the last treatment using the FES as well as evaluator- and subject-rated Global Aesthetic Improvement Scale (GAIS). Treatment was well tolerated, with no downtime or adverse events. One and three months after the last treatment session, physician-rated FES showed statistically significant improvement of 2.67±1.18 and 2.33±1.03, respectively (P<.0001), from baseline (4.83±0.69). According to the investigator assessment of improvement using the GAIS scale, all subjects had an improvement in skin texture and pigmentation and most of the patients (91.7%) had an improvement in skin brightness, tightness, and wrinkles. This is the first study evaluating the Legend+ RF System with VoluDerm technology using the novel gen100 ultra-thin electrodes tip. This study demonstrated effective and well-tolerated treatment for improving skin texture and appearance with minimal to no downtime.

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