Ablon Glynis
Dr. Ablon is an Assistant Clinical Professor at the University of California in Los Angeles, California.
J Clin Aesthet Dermatol. 2018 Aug;11(8):29-34. Epub 2018 Aug 1.
The purpose of this study was to evaluate the efficacy and safety of an automated microneedling device (Exceed, Amiea Med, MT.DERM GmbH, Berlin, Germany) when used for the rejuvenation of facial skin, as well as to generate data for an FDA 510K submission for the device. This was an open-label, single-center study. Forty-eight subjects aged 35 to 75 years with signs of facial skin aging were recruited. After consenting and satisfying inclusion criteria, each subject underwent four microneedling sessions 30 days apart. Subjects were assessed at baseline and at 30, 60, 90, and 150 days after the first treatment. Wrinkles were assessed using the Lemperle Grading Scale. Skin laxity and texture were assessed using a modified Alexiades-Armenakas Grading Scale. Digital fringe projection technology (PRIMOS) was used to determine skin topography of the periorbital and mesolabial areas. Mean improvements in global wrinkle score (mean of nine facial area grades), skin laxity, and skin texture at Day 150, compared to baseline were 1.23 (99% confidence interval [CI]: 1.11, 1.34), 1.09 (99% CI: 0.93, 1.26), and 1.54 (99% CI: 1.33, 1.75), respectively. Statistically significant mean improvements in these three measures were also observed at Day 90. Improvements in wrinkle grading and skin texture were confirmed by the PRIMOS profilometry. The treatment was well tolerated with minimal pain, discomfort, and downtime. Side effects were minor and easily managed. This study demonstrates that four microneedling treatments of facial skin, spaced four weeks apart, significantly improve lines, wrinkles, skin laxity and skin texture, 90 and 150 days after the first treatment. The treatment was well tolerated with minimal pain, discomfort, and downtime. Side effects were minor and easily managed compared to other invasive technologies, such as laser ablation and radiofrequency.
本研究的目的是评估一种自动微针设备（Exceed，Amiea Med，MT.DERM GmbH，柏林，德国）用于面部皮肤年轻化的疗效和安全性，并为该设备向美国食品药品监督管理局（FDA）提交510K申请生成数据。这是一项开放标签、单中心研究。招募了48名年龄在35至75岁之间有面部皮肤衰老迹象的受试者。在获得同意并满足纳入标准后，每位受试者每隔30天接受4次微针治疗。在基线以及首次治疗后的30、60、90和150天对受试者进行评估。使用Lemperle分级量表评估皱纹。使用改良的Alexiades-Armenakas分级量表评估皮肤松弛度和质地。使用数字条纹投影技术（PRIMOS）确定眶周和唇周区域的皮肤地形。与基线相比，在第150天时，全球皱纹评分（九个面部区域等级的平均值）、皮肤松弛度和皮肤质地的平均改善分别为1.23（99%置信区间[CI]：1.11，1.34）、1.09（99%CI：0.93，1.26）和1.54（99%CI：1.33，1.75）。在第90天时，在这三项指标上也观察到了具有统计学意义的平均改善。PRIMOS轮廓测量法证实了皱纹分级和皮肤质地的改善。该治疗耐受性良好，疼痛、不适和停工期最小。副作用轻微且易于处理。这项研究表明，面部皮肤每隔四周进行4次微针治疗，在首次治疗后的90天和150天可显著改善皱纹、皮肤松弛度和皮肤质地。与其他侵入性技术（如激光消融和射频）相比，该治疗耐受性良好，疼痛、不适和停工期最小，副作用轻微且易于处理。
