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一项双盲、随机研究:比较两种润肤产品对干性皮肤特应性皮炎患者的皮肤水合作用及可接受性

A Double-Blind, Randomised Study Comparing the Skin Hydration and Acceptability of Two Emollient Products in Atopic Eczema Patients with Dry Skin.

作者信息

Djokic-Gallagher Jasmina, Rosher Phil, Oliveira Gabriela, Walker Jennine

机构信息

Dermal Laboratories Ltd, Hitchin, UK.

出版信息

Dermatol Ther (Heidelb). 2017 Sep;7(3):397-406. doi: 10.1007/s13555-017-0188-z. Epub 2017 Jul 4.

Abstract

INTRODUCTION

Healthcare professionals tend to recommend emollients based primarily on patient/consumer preference and cost, with cheaper options assumed to be therapeutically equivalent. The aim of this study was therefore to compare the effects on skin hydration of two emollients prescribed in the UK, Doublebase Dayleve™ gel (DELP) and a cheaper alternative, Zerobase Emollient™ cream (ZBC).

METHODS

This was a single-centre, randomised, double-blind, concurrent bi-lateral (within-patient) comparison in 18 females with atopic eczema and dry skin on their lower legs. DELP gel and ZBC cream were each applied to one lower leg twice daily for 4 days and on the morning only on day 5. The efficacy of both products was assessed by hydration measurements using a Corneometer CM825 probe (Courage-Khazaka Electronic). The measurements were made three times daily on days 1 to 5. The primary efficacy variable was the area under the curve (AUC) of the change from baseline corneometer readings over the 5 days.

RESULTS

Skin hydration using DELP gel was significantly higher than using ZBC cream (p < 0.0001). The cumulative increase in skin hydration observed for DELP gel was substantial and long lasting. In contrast, for ZBC cream, there was no significant improvement of the cumulative skin hydration as measured by the AUC (p = 0.22).

CONCLUSION

DELP gel achieved substantial, long-lasting and cumulative skin hydration, whilst ZBC cream achieved no measurable improvement in skin hydration compared to before treatment. Healthcare professionals should be aware that different emollients can perform differently.

FUNDING

Dermal Laboratories Ltd.

TRIAL REGISTRATION

EudraCT number:2014-001026-16.

摘要

引言

医疗保健专业人员倾向于主要根据患者/消费者的偏好和成本来推荐润肤剂,认为较便宜的产品在治疗效果上是等效的。因此,本研究的目的是比较英国开具的两种润肤剂——双碱基日霜凝胶(DELP)和一种较便宜的替代品——零碱基润肤霜(ZBC)对皮肤水合作用的影响。

方法

这是一项单中心、随机、双盲、同期双侧(患者内)比较研究,纳入了18名患有特应性皮炎且小腿皮肤干燥的女性。DELP凝胶和ZBC乳膏分别每天两次涂抹于一条小腿,持续4天,第5天仅在早晨涂抹。使用角质层水合测定仪CM825探头(Courage-Khazaka电子公司)通过水合测量来评估两种产品的疗效。在第1至5天每天进行三次测量。主要疗效变量是5天内角质层测量仪读数相对于基线变化的曲线下面积(AUC)。

结果

使用DELP凝胶时的皮肤水合作用显著高于使用ZBC乳膏(p < 0.0001)。观察到DELP凝胶使皮肤水合作用的累积增加显著且持久。相比之下,对于ZBC乳膏,通过AUC测量的累积皮肤水合作用没有显著改善(p = 0.22)。

结论

DELP凝胶实现了显著、持久和累积的皮肤水合作用,而ZBC乳膏与治疗前相比在皮肤水合作用方面没有可测量的改善。医疗保健专业人员应意识到不同的润肤剂可能有不同的表现。

资金来源

皮肤实验室有限公司。

试验注册号

欧盟临床试验数据库编号:2014-001026-16。

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