EUCTR2004-003901-25-GB进行中（未招募）1 期
A multi-centre, double-blind, vehicle-controlled, randomised group comparative trial to evaluate the efficacy, steroid sparing properties, safety and acceptability of a topically applied sodium cromoglicate lotion (Altoderm®) in the treatment of atopic dermatitis in children.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •At screening
- •»Children of either sex aged between 1 and 16 years.
- •»Children with atopic dermatitis according to criteria according to the UK Working Party for diagnostic criteria for atopic dermatitis [1]. These are:
- •lMust have an itchy skin condition (or report of scratching or rubbing in a child).
- •lPlus three or more of the following
- •–History of itchiness in skin creases such as folds of the elbows, behind the knees, fronts of ankles, or around the neck (or the cheeks in children less than 4 years).
- •–History of asthma or hay fever (or history of atopic disease in a first degree relative in children under 4 years)
- •–General dry skin in the past year
- •–Visible flexural eczema (or eczema affecting the cheeks or forehead and outer limbs in children under 4 years)
- •–Onset in the first two years of life
- •»Children with atopic dermatitis who at the Screening Visit (Visit 1) and at Visit 2 exhibit a score using the SCORAD scoring system for atopic dermatitis of =25 [2]
- •»Children of parents, one of whom gives signed, informed consent to participate in the trial.
- •At entry to double blind period
- •»Children who, according to the European Task Force on Atopic Dermatitis [2] have a SCORAD score of =25 and scores for overall skin condition of 2 on at least 4 days of the 14 days of the baseline.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •»Children with any chronic disease other than associated allergic diseases,( which include recurrent wheezing, allergic rhinitis and food allergy).
- •»Children who have cardiovascular, neurological, hepatic, renal, gastrointestinal, or other significant acute or chronic medical indication which, in the judgement of the investigator, might interfere with the study or required treatment.
- •»Patients who have received oral corticosteroids or corticosteroids by injection within the past 3 months.
研究者
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