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Assessment of safety and efficacy of a bipolar fractionated radiofrequency device in the treatment of photodamaged skin

机译:评估双极分频射频设备治疗光损伤皮肤的安全性和有效性

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摘要

Background: A number of devices are available for skin rejuvenation and conventional devices include both ablative and non-ablative lasers. More recently, bipolar fractionated radiofrequency (RF) devices have been introduced. Objective: To evaluate the safety and efficacy of a novel 144 pin high density tip bipolar fractionated radiofrequency (RF) device for skin rejuvenation in Fitzpatrick skin types I-IV. Methods and materials: This single-center, prospective, study enrolled 25 female between the ages of 35-60 years, with mild to moderate wrinkling based on the Fitzpatrick Wrinkle Scale. The subjects were of Fitzpatrick skin types I-IV. Each subject underwent 3 full-face treatments with a 144 pin fractional bipolar RF device at 30-day intervals. All subjects underwent clinical evaluations during the study period to evaluate for any adverse events. Subsequently, all subjects were evaluated for improvement in rhytides, dyschromias and skin texture based on photographic evaluation by blinded investigators at 6 months following the final RF treatment. Results: A statistically significant improvement in rhytides, dyschromias and texture was noted. Adverse events were limited to mild erythema and swelling. Post-inflammatory pigmentary changes were not observed in any subjects. Conclusion: The novel 144 pin high density tip bipolar fractionated RF device is both safe and effective for facial skin rejuvenation in Fitzpatrick skin types I-IV.
机译:背景技术:许多设备可用于嫩肤,常规设备包括烧蚀激光和非烧蚀激光。最近,已经引入了双极分级射频(RF)设备。目的:评估新型144针高密度尖端双极分频射频(RF)装置在Fitzpatrick I-IV型皮肤中复兴的安全性和有效性。方法和材料:这项单中心,前瞻性研究招募了25名年龄在35至60岁之间的女性,根据Fitzpatrick皱纹量表进行了轻度到中度的皱纹。受试者为费兹帕特里克I-IV型皮肤。每位受试者每30天用144针分数双极RF设备进行3次全脸治疗。在研究期间,所有受试者均接受了临床评估,以评估是否有不良事件。随后,在最后的RF治疗后6个月,由盲人研究人员根据照相评估,对所有受试者的除皱,色差和皮肤质地的改善进行评估。结果:观察到在Rhytides,色差和质地上有统计学上的显着改善。不良事件仅限于轻度红斑和肿胀。在任何受试者中均未观察到炎症后的色素变化。结论:新颖的144针高密度尖端双极分流式RF装置对于Fitzpatrick I-IV型皮肤的面部嫩肤既安全又有效。

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