Department of Pediatrics, Hamamatsu University School of Medicine, Shizuoka, Japan.
Department of Pediatrics, Hamamatsu University School of Medicine, Shizuoka, Japan.
Allergol Int. 2024 Jul;73(3):428-435. doi: 10.1016/j.alit.2024.01.007. Epub 2024 Feb 2.
Washing with water is not inferior to washing with soaps and detergents in children with atopic dermatitis (AD) in remission during the fall-winter seasons. We investigated whether this finding varies during summer based on the type of cleanser (soaps and detergents).
This evaluator-blinded, pragmatic, randomized, and non-inferiority study enrolled patients with AD whose eczema was controlled following regular steroid ointment application 2 days/week. For 8 ± 4 weeks, participants washed their upper and lower limbs with a cleanser on one side and with water alone on the other. Each participant chose either a weakly alkaline soap or an acidic detergent. The primary outcome was the Eczema Area and Severity Index (EASI) score at week 8 ± 4.
The data of 43 of the 47 registered participants were analyzed. The median patient age was 44 (23-99) months; 28 and 15 participants chose weakly alkaline and acidic cleansers, respectively. At week 8 ± 4, EASI scores of the water and cleanser sides were 0.00 (0.00-0.40) and 0.15 (0.00-0.40), respectively (p = 0.74). The difference between both sides was 0.00 (-0.07 to 0.14); the limits of the 95 % confidence interval did not reach the pre-specified non-inferiority margin. No difference was observed in the median Patient-Oriented Eczema Measure score, number of additional steroid ointment applications, and occurrences of skin infections. There were no differences between the cleanser types in any of the results.
We demonstrated that washing with water was not inferior to that with a cleanser in patients with AD in the maintenance phase during summer, regardless of the type of cleanser.
在秋冬季节,患有特应性皮炎(AD)且处于缓解期的儿童用清水清洗并不亚于用肥皂和清洁剂清洗。我们研究了在夏季,基于清洁剂(肥皂和清洁剂)的类型,这一发现是否会有所不同。
这是一项评估者设盲、实用、随机、非劣效性研究,纳入了 AD 患者,他们在每周 2 天使用常规类固醇软膏治疗后,湿疹得到控制。在 8±4 周内,参与者用清洁剂清洁一侧的上下肢,另一侧只用清水。每位参与者选择弱碱性肥皂或酸性清洁剂。主要结局是 8±4 周时的湿疹面积及严重程度指数(EASI)评分。
47 名登记参与者中有 43 名的数据被分析。中位患者年龄为 44(23-99)个月;28 名和 15 名参与者分别选择了弱碱性和酸性清洁剂。8±4 周时,水侧和清洁剂侧的 EASI 评分分别为 0.00(0.00-0.40)和 0.15(0.00-0.40)(p=0.74)。两侧差异为 0.00(-0.07 至 0.14);95%置信区间的上限未达到预设的非劣效性边界。在额外使用类固醇软膏的次数和皮肤感染的发生率方面,两侧之间没有差异。在任何结果中,清洁剂类型之间也没有差异。
我们证明了在夏季维持期,AD 患者用清水清洗并不亚于用清洁剂清洗,无论清洁剂的类型如何。