Impact of the Daily Use of the Tested Emollient on Corticosteroids Consumption in Patients Minimum 3 Years Old With Atopic Dermatitis (SCORAD 20-30) Versus Their Usual Emollient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- efficacy of treatments
研究概览
简要总结
This study aims at assessing the reduction of consumption of corticosteroids (same mid-potent corticosteroids for all patients) afforded by the use of a specific emollient in comparison to the usual one in subjects suffering from atopic dermatitis.
详细描述
The study is conducted in compliance, as closely as possible, with the current version of the world medical association declaration of Helsinki, local regulations based on International Council on Harmonisation (ICH) guidelines for Good Clinical Practice.
The primary objective of this study is to compare the tested emollient and the usual emollient through the weight of used dermocorticosteroid. The weight of used dermocorticosteroid is compared at the end of the study by a Student t-test (or a non parametric Wilcoxon test depending on the data distribution).
The following hypotheses are used for the estimation of the sample size calculation:
- Power (1 - β) = 80%
- Two-sided significance level (α) = 5%
- Expected inter-group difference = 0.6g
- Standard deviation = 1.4g.
Statistical analyses is performed with SAS® version 9.4 or higher (SAS institute, North Carolina, USA).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of atopic dermatitis must meet Hanifin's criteria (at least 3 basic features and at least 3 minor features)
- •mild atopic dermatitis present for at least 6 months before inclusion (SCORAD at inclusion between 20 and 30)
- •able to apply the emollient (each morning and evening) during a three-month period
排除标准
- •presenting with another dermatological condition that could interfere with clinical evaluation
- •having received any systemic treatment, including PUVAtherapy for atopic dermatitis in the month prior to Day 0
- •who intend to expose themselves to the sun during the trial
结局指标
主要结局
efficacy of treatments
时间窗: from baseline to Day84
the efficacy of treatments is evaluated by corticosteroids consumption (weight of product and number of applications)
次要结局
- change in global efficacy(from Day28 to Day84)
- change in SCORing Atopic Dermatitis (SCORAD) measure(from baseline to Day84)
- change in the quality of life (patients aged 18 years or over)(from baseline to Day84)
- change in Patient-Oriented SCORing Atopic Dermatitis (PO-SCORAD) measure(from baseline to Day84)
- change in global tolerance(from Day28 to Day84)
- change in Patient Benefit Index (PBI) measure(from baseline to Day84)
- change in LOCAL SCORing Atopic Dermatitis (LOCAL SCORAD) measure(from baseline to Day84)
- change in cutaneous discomfort(from baseline to Day84)
- change in the quality of life (patients aged less than 18 years)(from baseline to Day84)