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Subdermal Radiofrequency for Skin Tightening of the Posterior Upper Arms

机译:皮下射频紧肤后臂

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BACKGROUNDSubsurface thermistor-controlled monopolar radiofrequency (SMRF) is an emerging technology designed to offer a minimally invasive option for tightening of lax skin. The versatility of this technique allows it to be applied to virtually any body site.OBJECTIVEThe purpose of this study is to evaluate the safety and efficacy of SMRF for tightening of posterior upper arm skin laxity.PATIENTSThis is a prospective, open-label clinical trial involving 12 subjects aged 18 to 65 with moderate-to-severe skin laxity in the posterior upper arms.METHODS/MATERIALSEach subject received treatment to the bilateral arms resulting in a population of n = 24 arms in the analysis group. Treatment consisted of SMRF delivered at Day 0 of the trial. Follow-up evaluation was conducted at Day 7, 30, and 90 post-treatment. The primary end point was the assessment of skin laxity by a nontreating physician utilizing a standardized 5 point Skin Laxity Grading Scale at baseline, Days 30 and 90. Subject self-evaluation of firmness, laxity, texture, and satisfaction was also collected. Circumferential and vertical arm measurements were obtained via digital fractional caliper. An adverse event profile was categorized.RESULTSSignificant improvements in skin laxity were observed at both Day 30 and at Day 90 post-treatment as assessed by the nontreating investigator. Subjects also rated significant improvements in the firmness, texture, and laxity of their treated arms. The majority of subjects were satisfied to extremely satisfied with their results. Adverse events recorded at Day 7 post-treatment included erythema (4%), contour irregularity (4%), and bruising (13%). All adverse events resolved completely by Day 30 post-treatment.CONCLUSIONThermistor-controlled SMRF is a safe and effective means to treating posterior upper arm skin laxity.
机译:背景技术地下热敏电阻控制的单极射频(SMRF)是一种新兴技术,旨在为收紧松弛的皮肤提供微创的选择。目的本技术的目的是评估SMRF收紧后上臂皮肤松弛的安全性和有效性。患者这是一项前瞻性,开放标签的临床试验,涉及12位年龄在18至65岁之间的受试者在上臂后部皮肤松弛至中度至重度。方法/材料每位受试者均接受了双侧臂的治疗,分析组中n = 24臂。治疗包括在试验第0天交付的SMRF。在治疗后第7、30和90天进行随访评估。主要终点是由非治疗医师在基线的第30天和第90天使用标准化的5点皮肤松弛度分级量表对皮肤松弛度进行评估。还收集了受试者对紧致度,松弛度,质地和满意度的自我评估。周长和垂直臂测量值是通过数字分数卡尺获得的。不良事件的情况分类。结果由非治疗研究者评估,在治疗后第30天和第90天都观察到皮肤松弛的明显改善。受试者还对治疗后的手臂的紧实度,质地和松弛度进行了显着改善。大多数受试者对他们的结果感到非常满意。治疗后第7天记录的不良事件包括红斑(4%),轮廓不规则(4%)和青紫(13%)。治疗后第30天,所有不良事件均已完全解决。结论热敏电阻控制的SMRF是治疗后上臂皮肤松弛的安全有效方法。

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