Montelukast as Adjunct Treatment in Children With Atopic Dermatitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in SCORAD Scoring Atopic Dermatitis index (Units on a scale)
研究概览
简要总结
An open-label (outcome assessor blinded) prospective crossover cohort study of children 6-16 years assessing effects of Montelukast on moderate to severe atopic dermatitis.
详细描述
An open-label, prospective cohort study with two arms over 16 weeks comprising 8 weeks of treatment with montelukast and 8 weeks without treatment of montelukast. All patients will be followed from recruitment to the study end date.
Study Population 62 patients aged 6-16 years old with moderate to severe atopic dermatitis recruited from the Royal Children's Hospital and Box Hill Hospital dermatology clinics having already previously received eczema education (SCORAD >25) Study Product Oral tablet montelukast Dose Regimen For patients 6-8 years old - 4mg montelukast once daily For patients 9-13 years old - 5mg montelukast once daily For patients 14-16 years old - 10mg montelukast once daily Evaluation Criteria Primary objective measurement: mean change in SCORAD index at 8 weeks Patients will be randomized into 2 arms: Arm 1 treated with montelukast therapy over 8 weeks followed by no montelukast therapy for 8 weeks. Arm 2 followed for 8 weeks without montelukast therapy followed by 8 weeks with montelukast therapy.
Assessment Schedule Clinical assessment will be conducted at baseline (week 0), and reviewed every 4 weeks over 16 weeks with a safety follow-up visit 2 weeks after the treatment ends (week 18). At the first clinic visit, demographic data, medical history and baseline SCORAD and cDLQI will be recorded. cDLQI will be completed by the participants. Participants with SCORAD <25 are considered to have mild disease and will not be included in the study. Suitable participants will be prescribed oral montelukast as an adjunct to their standard topical therapy (corticosteroids, emollients) or immunosuppressive therapy. Adverse effects, SCORAD (assessed by a blinded assessor) and cDLQI will be assessed at each review.
Data will be analyzed based on intention-to-treat. Paired data on SCORAD and cDLQI will be analyzed. A p value <0.05 will be considered statistically significant. A 30% improvement in SCORAD and cDLQI scores will be considered clinically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 6-16 years old with moderate to severe atopic dermatitis (SCORAD >25) despite topical therapy (corticosteroids and emollients) for at least 2 months Patients aged 6-16 years old with moderate to severe atopic dermatitis (SCORAD >25) despite immunosuppressive therapy (azathioprine, cyclosporine, methotrexate) for at least 2 months
排除标准
- •Patients with mild atopic dermatitis (SCORAD <25) Patients who have received phototherapy in the past 8 weeks Patients with history of sensitivity to leukotriene receptor antagonists
研究组 & 干预措施
Montelukast-Standard
8 weeks of montelukast and standard therapy crossing over to 8 weeks of only standard therapy
干预措施: Montelukast (Drug)
Standard-Montelukast
8 weeks of standard therapy only crossing over to 8 weeks of montelukast and standard therapy
干预措施: Montelukast (Drug)
结局指标
主要结局
Change in SCORAD Scoring Atopic Dermatitis index (Units on a scale)
时间窗: at 8 weeks
assessed by blinded assessor
次要结局
- Change in SCORAD Scoring Atopic Dermatitis index (Units on a scale)(at 4 weeks)
- Change in children's Dermatology Life Quality Index cDLQI (Units on a scale)(at 4 weeks)