Background

To our knowledge, there are no trials comparing emollients commonly used for childhood eczema. We aimed to compare the clinical effectiveness and safety of the four main emollient types: lotions, creams, gels, and ointments.

Methods

We did a pragmatic, individually randomised, parallel group, phase 4 superiority trial in 77 general practice surgeries in England. Children aged between 6 months and 12 years with eczema (Patient Orientated Eczema Measure [POEM] score >2) were randomly assigned (1:1:1:1; stratified by centre and minimised by baseline POEM score and age, using a web-based system) to lotions, creams, gels, or ointments. Clinicians and parents were unmasked. The initial emollient prescription was for 500 g or 500 mL, to be applied twice daily and as required. Subsequent prescriptions were determined by the family. The primary outcome was parent-reported eczema severity over 16 weeks (weekly POEM), with analysis as randomly assigned regardless of adherence, adjusting for baseline and stratification variables. Safety was assessed in all randomly assigned participants. This trial was registered with the ISRCTN registry, ISRCTN84540529.

Findings

Between Jan 19, 2018, and Oct 31, 2019, 12 417 children were assessed for eligibility, 550 of whom were randomly assigned to a treatment group (137 to lotion, 140 to cream, 135 to gel, and 138 to ointment). The numbers of participants who contributed at least two POEM scores and were included in the primary analysis were 131 in the lotion group, 137 in the cream group, 130 in the gel group, and 126 in the ointment group. Baseline median age was 4 years (IQR 2–8); 255 (46%) participants were girls, 295 (54%) were boys; 473 (86%) participants were White; and the mean POEM score was 9·3 (SD 5·5). There was no difference in eczema severity between emollient types over 16 weeks (global p value=0·77), with adjusted POEM pairwise differences of: cream versus lotion 0·42 (95% CI −0·48 to 1·32), gel versus lotion 0·17 (−0·75 to 1·09), ointment versus lotion −0·01 (−0·93 to 0·91), gel versus cream −0·25 (−1·15 to 0·65), ointment versus cream −0·43 (−1·34 to 0·48), and ointment versus gel −0·18 (−1·11 to 0·75). This result remained unchanged following multiple imputation, sensitivity, and subgroup analyses. The total number of adverse events did not significantly differ between the treatment groups (lotions 49 [36%], creams 54 [39%], gels 54 [40%], and ointments 48 [35%]; p=0·79), although stinging was less common with ointments (12 [9%] of 138 participants) than lotions (28 [20%] of 137), creams (24 [17%] of 140), or gels (25 [19%] of 135).

Interpretation

We found no difference in effectiveness between the four main types of emollients for childhood eczema. Users need to be able to choose from a range of emollients to find one that they are more likely to use effectively.

Funding

National Institute for Health and Care Research.

中文翻译：

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乳液、乳霜、凝胶和软膏润肤剂对儿童湿疹的有效性和安全性：一项实用的、随机的、4 期优效性试验

背景

据我们所知，目前还没有比较常用于治疗儿童湿疹的润肤剂的试验。我们的目的是比较四种主要润肤剂类型的临床有效性和安全性：乳液、乳霜、凝胶和软膏。

方法

我们在英格兰的 77 个全科手术中进行了一项务实的、单独随机化的平行组 4 期优势试验。年龄在 6 个月至 12 岁之间患有湿疹的儿童（以患者为导向的湿疹测量 [POEM] 评分 > 2）被随机分配（1:1:1:1；按中心分层并按基线 POEM 评分和年龄最小化，使用网络-基于系统）到乳液、乳霜、凝胶或软膏。临床医生和家长都被揭穿了。最初的润肤剂处方为 500 g 或 500 mL，每日两次并根据需要使用。后来的药方都是由家属决定的。主要结果是父母报告的超过 16 周的湿疹严重程度（每周 POEM），随机分配的分析与依从性无关，根据基线和分层变量进行调整。在所有随机分配的参与者中评估了安全性。该试验已在 ISRCTN 登记处注册，ISRCTN84540529。

发现

2018 年 1 月 19 日至 2019 年 10 月 31 日期间，对 12,417 名儿童进行了资格评估，其中 550 名被随机分配到治疗组（137 名分配至洗剂，140 名分配至乳膏，135 名分配至凝胶，138 名分配至软膏）。贡献至少两项 POEM 分数并被纳入主要分析的参与者人数为洗剂组 131 人、乳膏组 137 人、凝胶组 130 人和软膏组 126 人。基线中位年龄为 4 岁（IQR 2-8）；255 (46%) 名参与者是女孩，295 (54%) 名参与者是男孩；473 (86%) 名参与者是白人；平均 POEM 分数为 9·3 (SD 5·5)。在 16 周内润肤剂类型之间的湿疹严重程度没有差异（全局 p 值 = 0·77），调整后的 POEM 配对差异为：乳膏与乳液 0·42（95% CI -0·48 至 1·32），凝胶与乳液 0·17（-0·75 至 1·09），软膏与乳液 -0·01（-0·93 至 0·91），凝胶与乳膏 -0·25（-1·15 至 0·65），软膏与乳膏 -0·43（-1·34 至 0） ·48)，软膏对比凝胶 -0·18 (-1·11 至 0·75)。经过多重插补、敏感性和亚组分析后，该结果保持不变。不良事件总数在治疗组之间没有显着差异（乳液 49 [36%]、乳膏 54 [39%]、凝胶 54 [40%] 和软膏 48 [35%]；p=0·79） ，尽管与乳液（137 人中的 28 [20%]）、面霜（140 人中的 24 [17%]）或凝胶（25 [19%] 135). 和亚组分析。不良事件总数在治疗组之间没有显着差异（乳液 49 [36%]、乳膏 54 [39%]、凝胶 54 [40%] 和软膏 48 [35%]；p=0·79） ，尽管与乳液（137 人中的 28 [20%]）、面霜（140 人中的 24 [17%]）或凝胶（25 [19%] 135). 和亚组分析。不良事件总数在治疗组之间没有显着差异（乳液 49 [36%]、乳膏 54 [39%]、凝胶 54 [40%] 和软膏 48 [35%]；p=0·79） ，尽管与乳液（137 人中的 28 [20%]）、面霜（140 人中的 24 [17%]）或凝胶（25 [19%] 135).

解释

我们发现四种主要类型的润肤剂对儿童湿疹的疗效没有差异。用户需要能够从一系列润肤剂中进行选择，以找到他们更有可能有效使用的润肤剂。

资金

国家健康与护理研究所。