A trial of topical sodium cromoglicate in atopic dermatitis in childre

Thornton and Ross Ltd (UK)0 个研究点目标入组 174 人开始时间: 2005年10月12日最近更新: 2015年1月13日

适应症

试验速览

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•1. Children of either sex aged between 1 and 12 years (after the first birthday and before the 13th birthday)
•2. Children with atopic dermatitis according to the UK Working Party for diagnostic criteria for atopic dermatitis. These are:
•2.1. Must have an itchy skin condition (or report of scratching or rubbing in a child)
•2.2. Plus three or more of the following:
•2.2.1. 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)
•2.2.2. History of asthma or hay fever (or history of atopic disease in a first degree relative in children under 4 years)
•2.2.3. General dry skin in the past year
•2.2.4. Visible flexural eczema (or eczema affecting the cheeks or forehead and outer limbs in children under 4 years)
•2.2.5. Onset in the first two years of life
•3. Children with atopic dermatitis who at the Screening Visit (Visit 1) and at Visit 2 exhibit a score using the SCORing Atopic Dermatitis (SCORAD) scoring system for atopic dermatitis of greater than or equal to 25
•4. Children of parents, one of whom gives signed, informed consent to participate in the trial

•1. Children with any chronic disease other than associated allergic diseases (which include recurrent wheezing, allergic rhinitis and food allergy)
•2. 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 require treatment
•3. Patients who have received oral corticosteroids or corticosteroids by injection within the past 3 months

发起方

Thornton and Ross Ltd (UK)