An Exploratory and Monocentric Study to Assess Clinical, Biological and Biometrological Paramaters in Adult Subjects With Mild to Moderate Atopic Dermatitis (AD)

Pierre Fabre Dermo Cosmetique2 个研究点分布在 1 个国家目标入组 12 人开始时间: 2022年3月8日最近更新: 2022年12月6日

适应症

试验速览

阶段: 不适用
状态: 终止
发起方
入组人数: 12
试验地点: 2
主要终点: Assessment of skin barrier condition in Atopic Dermatitis during and outside flares-up

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of the study is to collect different parameters (clinical, biological and biometrological) of Atopic Dermatitis (AD) in order to identify which factors are modified during the flare-up phase.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Other
盲法: None

入排标准

年龄范围: 18 Years 至 50 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Subject aged between 18 to 50 years included
•Subject suffering from Atopic Dermatitis according to the "U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis" (6)
•Subject with mild to moderate Atopic Dermatitis with 20 <= SCORAD <= 40 at inclusion
•Subject with flare frequency ≥ 4 on the target areas over the last year
•Subject with a cutaneous target area, allowing the measurements, located on upper or lower limbs and defined as a usual AD flare area according to the subject
•Subject with a target area with 22 <= target SCORAD signs <= 10 following:
•Erythema ≥ 1
•Dryness ≥ 1 1
•Subject with a control area, allowing the measurements, located on upper or lower limbs and defined as :
•A non- usual AD flare area according to the subject and the investigator
•A sufficient distance from the cutaneous target area according to the investigator

排除标准

•Subject with a surinfected AD
•Subject having any other dermatologic condition other than AD or characteristics (e.g: tatoo) on the target area liable to interfere with the study assessments
•Subject with another dermatologic condition, acute or chronic or disease or history of disease considered by the investigator, liable to interfere with the study assessments, or hazardous for the subject or incompatible with the study according to the investigator
•Any surgical intervention on upper or lower limbs during the previous weeks or months liable to interfere with the study data according to the investigator
•Systemic immunosuppressive therapy (excepted systemic corticoids) within 3 months before the inclusion visit or ongoing at inclusion visit (except during flare period)
•Systemic corticoids taken within 4 weeks before the inclusion visit or ongoing at inclusion visit (except during flare period)
•Phototherapy performed within 4 weeks before the inclusion visit or ongoing at inclusion visit (except during flare period)
•Systemic antibiotics taken within 7 days before the inclusion visit or ongoing at inclusion visit (except during flare period)
•Moderate to high-potency topical corticosteroids applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit (except during flare period)
•Topical immunomodulators, applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit (except during flare period)
•Topical or oral treatment instaurated or modified before the inclusion visit or planned to be instaurated during the study or ongoing at inclusion visit, liable to interfere with the study, according to the investigator