ISRCTN02084571已完成3 期
A multicentre, double-blind, vehicle-controlled, randomised group-comparative study to evaluate the efficacy and safety of Altoderm™, a topically-applied sodium cromoglicate lotion, in the treatment of atopic dermatitis in children
Thornton & Ross Ltd (UK)0 个研究点目标入组 180 人开始时间: 2009年4月30日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •At screening:
- •1. Children of either sex aged over 2 years but less than 12 years (after 2nd birthday and before 12th birthday)
- •2. Children with atopic dermatitis according to criteria of 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. 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 who have a SCORing Atopic Dermatitis (SCORAD) of greater than or equal to 25 and less than or equal to 60
- •4. Children with atopic dermatitis whose parent(s) agree to:
- •4.1. Keep daily diary cards throughout the 16 weeks of the study, in order to record:
- •4.1.1. The weight and number of times, each day, they use their emollients and topical steroids during the baseline and emollients, topical steroids and test medication during the double-blind period
- •4.1.2. The child's eczema (skin condition, itching and sleep disturbance on a 4 point scale)
- •4.2. Ensure that their emollient is applied at least twice daily throughout the baseline period (weeks 1 - 4) but only as required during the double blind period (weeks 5 - 16)
- •5. Children who are able, in the investigator's opinion, to understand the issues, give signed, informed consent to participate in the trial
- •6. Children of parents (or legal guardians) who give signed, informed consent to participate in the trial
- •At entry to double blind period:
- •Children who, having been treated with emollients on a regular basis for 4 weeks (baseline period), have a SCORAD of greater than or equal to 25 and less than or equal to 60 and diary card scores for skin itch and overall skin condition of 2 or greater (using a 0 - 3 scale), on at least 4 days of the last 14 days of the baseline period.
排除标准
- •1. Children with any other chronic disease with the exception of those associated allergic diseases (such as recurrent wheezing, allergic rhinitis and food allergy) should be excluded
- •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 required treatment
- •3. Patients who have received oral corticosteroids or corticosteroids by injection within the past 2 months
- •4. Patients currently using wet wrapping or calcineurin immunomodulators or have used wet wrapping during the previous 7 days or calcineurin immunomodulators during the previous 4 weeks
研究者
相似试验
进行中（未招募）
不适用
A multicenter, double blind, vehicle-controlled, randomized study of photodynamic therapy (PDT) with Metvix®160 mg/g cream and Aktilite CL128 LED light in patients with multiple actinic keratoses on the face and/or scalp.actinic keratosisEUCTR2005-005015-13-DEPhotoCure ASA80
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.Atopic dermatitisEUCTR2004-003901-25-GBThornton & Ross Ltd90
进行中（未招募）
1 期
A research study looking at a new lotion for the treatment of eczema in children.Paediatric atopic dermatitisMedDRA version: 14.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2008-005469-67-GBThornton & Ross Limited200
进行中（未招募）
1 期
A clinical study to investigate the effect and safety of up to 6 months of treatment with inhaled Promixin in the treatment of chest infections causeed by Pseudomonas in people with a lung disease called bronchiectasisEUCTR2008-005045-34-GBProfile Pharma Ltd144
进行中（未招募）
不适用
A double-blind, vehicle-controlled, multi-centre, clinical study to investigate the efficacy and safety of up to 6 months of therapy with inhaled Promixin in the treatment of patients with non-cystic fibrosis bronchiectasis infected with Pseudomonas aeruginosa susceptible to Promixin - Inhaled Promixin in the treatment of non-CF bronchiectasisEUCTR2008-005045-34-IEProfile Pharma Ltd260