Jackson J Mark, Grove Gary L, Allenby Kent, Houser Tim
Division of Dermatology, University of Louisville, Louisville, KY, USA.
cyberDERM Clinical Studies, Broomall, PA, USA.
Dermatol Ther (Heidelb). 2017 Dec;7(4):507-514. doi: 10.1007/s13555-017-0209-y. Epub 2017 Nov 13.
In plaque psoriasis, the benefit of topical steroids is well established. The vehicle formulation of topical steroids may also provide benefit in addition to the effects of the steroid itself. DFD-01 (betamethasone dipropionate spray, 0.05%) is a formulation composed of a topical steroid in an emollient-like vehicle that enhances penetration to the target site of inflammation in the skin. The aim of this study was to assess the effect of DFD-01 and its vehicle on skin hydration and barrier function in compromised skin and to evaluate its effect on flexibility in healthy skin.
Eighteen healthy white volunteers were enrolled in each of two studies. In Study 1, dry shaving of volar forearms created a compromised skin barrier, through which transepidermal water loss (TEWL) was measured using an evaporimeter. Capacitance, a measure of epidermal hydration, was also measured at baseline and at 1, 2 and 4 h after application of DFD-01 or its vehicle formulation. In Study 2, intact skin flexibility was tested with a cutometer before and at 1, 2 and 4 h after application of DFD-01 or vehicle.
In Study 1, both DFD-01 and its vehicle were effective at reducing TEWL through the compromised stratum corneum. Capacitance measurements confirmed this finding; razor-chafed skin treated with either DFD-01 or vehicle exhibited levels of skin hydration similar to unshaved control skin. Study 2 found softening and greater flexibility of normal skin treated with either DFD-01 or vehicle compared with nontreated control skin samples.
These tests suggest that the DFD-01 formulation and its vehicle are each effective at retaining moisture within a damaged skin barrier and for softening and increasing the flexibility of intact skin.
Dr. Reddy's Laboratories.
在斑块状银屑病中，外用糖皮质激素的益处已得到充分证实。外用糖皮质激素的赋形剂配方除了激素本身的作用外，可能也有一定益处。DFD-01（0.05%二丙酸倍他米松喷雾剂）是一种由外用糖皮质激素与类似润肤剂的赋形剂组成的配方，可增强对皮肤炎症靶部位的渗透。本研究的目的是评估DFD-01及其赋形剂对受损皮肤的皮肤水合作用和屏障功能的影响，并评估其对健康皮肤柔韧性的影响。
两项研究各招募了18名健康白人志愿者。在研究1中，对掌侧前臂进行干式剃须造成皮肤屏障受损，通过蒸发仪测量经表皮水分流失（TEWL）。还在基线以及涂抹DFD-01或其赋形剂配方后1、2和4小时测量了作为表皮水合作用指标的电容。在研究2中，在涂抹DFD-01或赋形剂之前以及之后1、2和4小时，使用皮肤弹性测定仪测试完整皮肤的柔韧性。
在研究1中，DFD-01及其赋形剂均可有效降低通过受损角质层的TEWL。电容测量证实了这一发现；用DFD-01或赋形剂处理的剃须擦伤皮肤的皮肤水合水平与未剃须对照皮肤相似。研究2发现，与未处理的对照皮肤样本相比，用DFD-01或赋形剂处理的正常皮肤更柔软且柔韧性更好。
这些测试表明，DFD-01配方及其赋形剂均可有效在受损皮肤屏障内保持水分，并使完整皮肤软化并增加其柔韧性。
瑞迪博士实验室。
