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临床试验/CTRI/2019/07/020200
CTRI/2019/07/020200尚未招募不适用

Evaluation of a paraffin based moisturizer as compared to a ceramide based moisturizer in children with atopic dermatitis: A double blinded, two group equivalence randomised controlled trial

NA1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年7月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
NA
入组人数
70
试验地点
1
主要终点
Difference in SCORAD in children with mild to moderate AD receiving paraffin based moisturizer compared to ceramide based moisturizer used twice daily at 3 months

研究概览

简要总结

Atopic dermatitis is chronic relapsing inflammatory disease affecting upto 20% of childrens and 2-8 % adults. Since the main defect in atopic dermatitis is skin barrier dysfunction, use of moisturizers alone or along with topical steroid has shown improvement in disease activity in earlier studies.It is also seen that it results in improvement of duration in remission with reduction in relapse rate as well as decrease in amount of topical corticosteroid requirement. Paraffin based moisturizer are the most commonly used moisturizers, but there are only few studies using this moisturizer and they have shown improvement in disease activity. In recent years, there are many studies using ceramide based moisturizer and showing similar or marginally better improvement in disease activity. There are not many studies comparing different moisturizer though there is a huge difference in cost and patient affordability. There are some studies which has compared different types of moisturizers and found no significant difference. We plan to do this double blinded, two group equivalence randomised controlled trial in 70 children with mild to moderate atopic dermatitis to see their effect on disease activity and skin barrier function. The children will be followed up for 6 months to evaluate all the outcome parameters.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
1.00 Day(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Children <18 years of age with mild to moderate AD (SCORAD 15-40).

排除标准

  • a)Children with severe systemic illness b)Children receiving systemic immunosuppression therapy in last 1 month c)Children unable to come for follow up.

结局指标

主要结局

Difference in SCORAD in children with mild to moderate AD receiving paraffin based moisturizer compared to ceramide based moisturizer used twice daily at 3 months

时间窗: 3 months

次要结局

  • 1.Time to remission and disease-free duration in children with mild to moderate AD receiving paraffin based moisturizer compared to ceramide based moisturizer used twice daily at 6 months
  • 2.Improvement in TEWL values in children with mild to moderate AD receiving paraffin based moisturizer compared to ceramide based moisturizer used twice daily at 6 months as measured by DERMALAB, cortex technologies(6 months)
  • 3.Quantity of topical corticosteroid required in children with mild to moderate AD receiving paraffin based moisturizer compared to ceramide based moisturizer used twice daily at 6 months(6 months)

研究者

发起方
NA
申办方类型
Other [n/a]

研究点 (1)

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