Comparative, Multicentre, Randomised, Double-blind Study to Assess the Efficacy of Tacrolimus 0.03% Ointment Versus Fluticasone 0.005% Ointment in Children Aged 2 Years or Over Suffering From Moderate to Severe Atopic Dermatitis.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 487
- 主要终点
- Percentage of patients presenting at the week 3 visit (day 21) with an improvement of at least 60% in their modified Eczema Area and Severity Index (mEASI) in comparison to day 1
研究概览
简要总结
Children with atopic eczema and a poor response to topical corticosteroid applied either Protopic or Fluticasone ointment twice a day for 3 weeks. They could continue during 3 more weeks once a day if needed.
详细描述
Treatments were to be applied twice daily until clearance, for a maximum of 3 weeks and then, in case of uncleared residual lesions, once daily for up to 3 further weeks. In the event of a flare-up the treatment was to be resumed twice a day until the end of the study.
Statistical methods: An interim analysis was performed on 30% of the planned total sample size, i.e. 140 included patients who had completed the study, to reassess the assumptions made during the planning phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with moderate to severe atopic dermatitis (Rajka & Langeland score greater than or equal to 4.5) and who had responded insufficiently to conventional therapies
- •Female patients of childbearing age: effective means of contraception throughout the period of the study and for four weeks following the end of the study
- •Informed consent
- •Therapeutic washout for atopic dermatitis treatments
排除标准
- •Genetic epidermal barrier defect, such as Netherton's syndrome, or suffering from erythroderma
- •Any female patients who were pregnant or breast-feeding
- •Clinical infection due to the VZV virus (varicella, zona), HSV1-2 viruses (herpes), verruca vulgaris or molluscum contagiosum
- •Superinfected eczema
- •Known hypersensitivity to macrolides or to any other excipient in tacrolimus ointment
- •Known hypersensitivity to one of the agents contained in the fluticasone 0.005% ointment preparation
- •Ulcerated lesions, of whatever type
- •Moderate to severe acne or rosacea
- •Patients participating at the same time in another clinical study or who have participated in another clinical study within 28 days of the start of this study
- •substance abuse (including that of drugs and alcohol) or mental disorder/psychological state which, in the investigator's opinion, might interfere with the patient's follow-up
- •Known serologically proven HIV positivity
研究组 & 干预措施
A
干预措施: Tacrolimus 0.03% (Drug)
B
干预措施: Fluticasone 0.005% (Drug)
结局指标
主要结局
Percentage of patients presenting at the week 3 visit (day 21) with an improvement of at least 60% in their modified Eczema Area and Severity Index (mEASI) in comparison to day 1
时间窗: 3 weeks
次要结局
- mEASI and EASI scores at each visit and percentage change with respect to day 1(1 week and 3 weeks)
- Global assessment of clinical response by the physician at each visit after day 1(1 week and 3 weeks)
- Global assessment of clinical response by the patient/parents at each visit after day 1(1 week and 3 weeks)
- All clinical signs, including sleep quality, severity of pruritus and body surface area affected at each visit(1 week and 3 weeks)
- Compliance with the treatment assessed from the patient's diary(1 week and 3 weeks)
- Patient's quality of life assessed at day 1 and day 21(3 weeks)
- Incidence of adverse events during the study(6 weeks)