A Double Blind, Multicentre, Randomised, Parallel Group Study to Demonstrate the Equivalence of the Response to Vaccination of a Tacrolimus Ointment Regimen to a Steroid Ointment Regimen in Children With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 260
- 主要终点
- Percentage of patients with serum bactericidal antibody titer of ≥ 8
研究概览
简要总结
Seven-month study in pediatric patients (2-11 years) with moderate to severe AD who were considered to benefit from vaccination to prevent invasive disease caused by Neisseria meningitides serogroup C.
详细描述
At the week 1 visit, the patients were vaccinated with a protein-conjugated vaccine against meningitis. All patients received a challenge at the month 6 visit with a low dose of meningo polysaccharide vaccine. A control group of healthy subjects (not suffering from atopic dermatitis) received only the vaccination and the challenge dose.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate to severe atopic dermatitis and in need for treatment
- •Patients require vaccination to prevent invasive disease caused by Neisseria meningitidis serogroup C
排除标准
- •Patients have known hypersensitivity to macrolides, tacrolimus and any component of the vaccine
- •Patients have an acute severe febrile illness, genetic epidermal barrier defect such as Netherton's syndrome or generalized erythroderma, a skin infection on the affected and to be treated area
- •Patients have already received a meningo polysaccharide or conjugated vaccine against meningitis
研究组 & 干预措施
3
Control group vaccination and challenge dose only
干预措施: AC VAX (Biological)
1
tacrolimus ointment 0.03%
干预措施: AC VAX (Biological)
2
hydrocortisone acetate 1% and butyrate 0.1%
干预措施: AC VAX (Biological)
2
hydrocortisone acetate 1% and butyrate 0.1%
干预措施: hydrocortisone acetate ointment 1% (Drug)
2
hydrocortisone acetate 1% and butyrate 0.1%
干预措施: hydrocortisone butyrate ointment 0.1% (Drug)
1
tacrolimus ointment 0.03%
干预措施: tacrolimus ointment 0.03% (Drug)
3
Control group vaccination and challenge dose only
干预措施: Meningitec (Biological)
2
hydrocortisone acetate 1% and butyrate 0.1%
干预措施: Meningitec (Biological)
1
tacrolimus ointment 0.03%
干预措施: Meningitec (Biological)
结局指标
主要结局
Percentage of patients with serum bactericidal antibody titer of ≥ 8
时间窗: 5 weeks
次要结局
- Assessment of other immunological parameters(7 months)