Université François Rabelais Tours, France.
Int J Pharm. 2010 Aug 16;395(1-2):84-90. doi: 10.1016/j.ijpharm.2010.05.010. Epub 2010 May 22.
Topical steroids are efficient in vasoconstriction potential, which is linked to their anti-inflammatory activity. Low-frequency ultrasound (US) applied on the skin (sonophoresis) may enhance the transdermal transport of various steroids. We aimed to assess, in a simple, blinded, randomized controlled pilot study, the clinical efficiency of sonophoresis in increasing vasoconstriction by enhancing the transdermal penetration of topical steroids in human skin. The study took place in the Clinical Investigation Center of the University Hospital of Tours and involved healthy volunteers. Three circular zones were delimited on each of the subjects' forearms: zone 1 (right and left) received topical steroids with 1-h occlusion, zone 2 with 2-h occlusion, and zone 3 with massage. Forearms were randomized to first undergo US, using a 36 kHz probe, delivered in a pulsed mode (2s on/5s off), during 5 min, with a US intensity of 2.72 W/cm(2), or no US. We used betamethasone 17-valerate in cream form as the topical steroid. The primary outcome was difference between forearms in skin color (increased whiteness reflecting the intensity of vasoconstriction) measured by 2 scores: values obtained with a chromameter (the higher the value, the whiter the skin) and a clinical visual score. The measurements were taken by a dermatologist by blinded assessment. Fifteen subjects were included. Vasoconstriction was significantly higher with the topical steroid applied after US, especially in zone 2, than without US. Vasoconstriction was increased at 1, 2, 3, 4, and 6h (e.g., chromameter score 63.4 versus 65.2, p=0.017 at 4h) and disappeared at 24h. Moreover, 2-h occlusion gave higher vasoconstriction scores than did 1-h occlusion or massage alone, whether US was applied or not. The use of low-frequency US coupled with 2-h occlusion is a synergistic way to increase the efficiency of topical steroids by enhancing skin permeability.
局部类固醇在血管收缩潜力方面非常有效，这与其抗炎活性有关。低频超声（US）应用于皮肤（声透法）可以增强各种类固醇的经皮转运。我们旨在通过增强局部类固醇在人体皮肤中的经皮渗透来评估声透法在增加血管收缩方面的临床效果，这是一项简单、盲法、随机对照的初步研究。该研究在图尔大学医院的临床研究中心进行，涉及健康志愿者。在每个受试者的前臂上划定了三个圆形区域：区域 1（左右）接受局部类固醇治疗，并用 1 小时闭塞，区域 2 用 2 小时闭塞，区域 3 用按摩。前臂随机首先接受 US 治疗，使用 36 kHz 探头，以脉冲模式（2 秒 ON/5 秒 OFF）进行 5 分钟，US 强度为 2.72 W/cm²，或不进行 US。我们使用倍他米松 17-戊酸酯乳膏作为局部类固醇。主要结果是通过 2 个评分来比较前臂的皮肤颜色差异（增加的白色反映血管收缩的强度）：使用色度计（值越高，皮肤越白）和临床视觉评分获得的值。测量由皮肤科医生通过盲法评估进行。共纳入 15 名受试者。与未使用 US 相比，US 后应用局部类固醇时血管收缩明显更高，尤其是在区域 2。血管收缩在 1、2、3、4 和 6 小时增加（例如，色度计评分 63.4 与 65.2，p=0.017 在 4 小时），并在 24 小时消失。此外，与单独使用 1 小时闭塞或按摩相比，无论是否应用 US，2 小时闭塞均可产生更高的血管收缩评分。低频 US 与 2 小时闭塞的联合使用是一种增强皮肤通透性以提高局部类固醇效率的协同方法。
