Randomised Controlled, Double Blind Trial of Topical Twice Weekly Fluticasone Propionate Maintenance Treatment to Reduce Risk of Relapse in Mild or Moderate Atopic Dermatitis in Children
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Relapse in Atopic Dermatitis (AD).
研究概览
简要总结
The relapsing nature of atopic dermatitis (AD) presents a challenge for its long-term treatment. Efficacy and safety of corticosteroids have been proven in the acute treatment of AD, but not its efficacy and security to reduce or prevent relapses.
Objectives To investigate long-term management (16 weeks) of AD with fluticasone propionate (FP) 0,05% cream twice weekly in addition to an emollient (vehicle) after stabilization of an acute flare of AD with FP cream.
详细描述
Patients 2-10 years of age with a history of mild to moderate AD will be eligible for this multicentre, randomized, double-blind, controlled study if they present an acute flare of AD (<30% affected body surface area; no head). After successful treatment of the flare in an acute phase, patients will receive either, FP twice weekly plus vehicle or vehicle alone over a 16-week maintenance phase. The primary study end point will be probability of a relapse of AD occurring. We will conduct survivor analysis of results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children, aged 2 to 10 years, with mild or moderate acute flare of AD (SCORAD up to 50) and no treatment for this episode of AD.
- •written informed consent to patients' parents.
排除标准
- •>30% of affected body surface area AD.
- •Head affected.
- •Fluticasone o vehicle allergy.
- •Patients with any medical condition for which topical corticosteroids were contraindicated
- •Patients with other dermatological conditions that may have prevented accurate assessment of AD
- •Patients with receiving any concomitant medications that might have affected the study's outcome.
- •Other medical history that could interfere with the evaluation of study treatment.
研究组 & 干预措施
Fluticasone, cream
fluticasone propionate (FP) cream of 0.05%. The vehicle is:Base PFCO/W, Propyleneglycol and Water conservant.
干预措施: Fluticasone, cream (Drug)
Placebo, cream
Vehicle cream is composed by Base PFCO/W, Propyleneglycol and Water conservant.
干预措施: Placebo, (Drug)
结局指标
主要结局
Relapse in Atopic Dermatitis (AD).
时间窗: 16 weeks
The primary study end point will be probability of a relapse of AD occurring (the relapse rate of AD).
次要结局
- Time to relapse(16 weeks)
- Incidence of relapse(16 weeks)
- severity of the relapse(16 weeks)
- Adverse events and adverse effects(22 weeks)
- Therapeutic compliance(18 weeks)
研究者
Elena Rubio Gomis
Professor of Pharmacology. Clinical Pharmacology
University of Valencia