Placebo-controlled, double-blind, randomized, prospective study of a glycerol-based emollient on eczematous skin in atopic dermatitis: Biophysical and clinical evaluation
Placebo-controlled, double-blind, randomized, prospective study of a glycerol-based emollient on eczematous skin in atopic dermatitis: Biophysical and clinical evaluation
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DOI：
10.1159/000111134
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发表时间：
2008-01-01
影响因子：
2.7
通讯作者：
Fluhr, J. W.
中科院分区：
文献类型：
--
作者：
Breternitz, M.;Kowatzki, D.;Fluhr, J. W.
背景/目的：特应性皮炎（AD）是一种常见的慢性炎症性疾病，受局部、免疫、遗传和环境因素影响。 AD 的重要症状是皮肤干燥、剧烈瘙痒和表皮屏障功能受损。 AD 的治疗管理很困难，需要个体化的概念。保湿霜和润肤剂是干燥和发炎皮肤患者日常皮肤护理的有用且重要的治疗辅助剂。 g。广告。众所周知，甘油可以增加角质层 (SC) 水合作用，改善表皮屏障功能并减少炎症的临床症状。然而，尚未发表关于甘油对 AD 中屏障功能和 SC 水合作用功效的对照研究。在本研究中，将外用 20% 甘油制剂与其载体在 AD 患者中进行了比较。本研究的目的是在 III 期药物研究的整体框架内评估单一润肤成分对 AD 的作用。方法：在一项随机、双盲研究中，24 名 AD 患者每天两次使用甘油润肤剂治疗 4 周。使用生物物理、非侵入性仪器评估经皮失水、皮肤电容、红斑和皮肤表面 pH 值。评估了 SCORAD 和局部严重程度评分。经过两周的清除期后，对这些参数进行了评估，以量化该治疗的持续效果。结果：与不含甘油的安慰剂相比，含甘油乳膏治疗后皮下水合作用显着改善，表皮屏障功能得到恢复。含甘油乳膏和安慰剂之间的红斑值、SCORAD 和局部严重程度没有显着差异。然而，随着时间的推移，两组的评估参数均有所改善，这表明润肤剂治疗对 AD 的重要性。结论：甘油润肤剂对 AD 患者的皮肤有积极影响。它们增强 SC 水合作用。此外，可以通过安慰剂对照研究中完全注册药物功效研究的方案设计来评估皮肤护理产品。版权所有 (C) 2007 S. Karger AG，巴塞尔。
Background/Aims: Atopic dermatitis ( AD) is a frequent, chronic inflammatory disease influenced by local, immunological, genetic and environmental factors. Important symptoms of AD are dry skin, intense pruritus and impaired epidermal barrier function. The therapeutic management of AD is difficult and needs individualized concepts. Moisturizing creams and emollients are useful and important treatment adjuncts for the daily skin care of patients with dry and inflamed skin, e. g. AD. Glycerol is known to increase stratum corneum (SC) hydration, improve epidermal barrier function and decrease clinical signs of inflammation. However, no controlled study on the efficacy of glycerol on barrier function and SC hydration in AD has been published. In the present study, a topical 20% glycerol preparation was compared with its vehicle in patients with AD. The aim of the present study was to evaluate the effect of a single emollient ingredient in AD within the full frame of a phase III drug study. Methods: 24 patients with AD were treated for 4 weeks twice daily with a glycerol-based emollient in a randomized, double-blind study. Transepidermal water loss, skin capacitance, erythema and skin surface pH were assessed with biophysical, non-invasive instruments. The SCORAD and a local severity score were evaluated. After a wash-out period of 2 weeks, these parameters were assessed in order to quantify the sustained effect of this treatment. Results: SC hydration was significantly improved, and epidermal barrier function was restored under treatment with glycerol-containing cream compared to the glycerol-free placebo. No significant differences were detectable for erythema values, SCORAD and local severity between the glycerol-containing cream and placebo. However, an improvement over time was detectable in the assessed parameters in both groups indicating the importance of emollient treatment in AD. Conclusions: Glycerol-based emollients have a positive influence on the skin of patients with AD. They enhance the SC hydration. Furthermore, it was possible to evaluate skin care products with a protocol design for efficacy studies of fully registered drugs in a placebo-controlled study. Copyright (C) 2007 S. Karger AG, Basel.