The Efficacy of Cimetidin for Acute - Extrinsic Atopic Dermatitis Treated With Standard Therapy, a Study of Immunoglobulin E, Interleukin-4, Interleukin-12, and Interferon-Ɣ Serum Levels
试验速览
- 阶段
- 3 期
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- SCORAD change
研究概览
简要总结
Extrinsic - atopic dermatitis is characterized by increased of IgE serum levels. Acute extrinsic - atopic dermatitis is a type 1 hypersensitivity that involve various inflammatory mediator including Interleukin-4, Interleukin-12, and Interferon-Ɣ. Recent treatment of atopic dermatitis mainly focused on reducing the inflammation through topical and systemic regiments. However, no systemic medication could control the atopic dermatitis remission yet, and the current immunosuppressive agent used may cause many side effects if administered on a long term basis.
In the future, treatment of atopic dermatitis were specifically targeted to inhibit the role of Th2. Cimetidine is H2 receptor antihistamine that has been widely used as gastrointestinal medication for a long time. Cimetidine could modulate the immune system by activating the Th1 and lowering the Th2 activity, and lowering the IgE levels thus reducing the severity of atopic dermatitis.
详细描述
The aim of this study is to measure the efficacy of cimetidine for acute, extrinsic-atopic dermatitis treated with standard therapy using SCORAD as the clinical outcome. This study also measure Immunoglobulin E, Interleukin-4, Interleukin-12, and Interferon-Ɣ serum levels before and after treatment.
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
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Atopic dermatitis patients diagnosed with Hanifin Rajka criteria
- •Acute extrinsic atopic dermatitis
- •IgE levels above 200 IU/mL
- •Minimum weight 15kg
排除标准
- •Consumption of corticosteroid and systemic immunosuppressant within the last 2 weeks
- •Chronic lesion
- •Consumption of drugs that reacts with cimetidine
- •Disturbance in lab results including complete blood count, liver function, and renal function.
- •Other conditions that might increase IgE levels
研究组 & 干预措施
Cimetidine
干预措施: Cimetidine (Drug)
Placebo
干预措施: Placebos (Drug)
结局指标
主要结局
SCORAD change
时间窗: 0, 2, 4, 6, 8 weeks
Scoring Atopic Dermatitis (SCORAD) is a score to indicate the severity of atopic dermatitis. The minimum score is 0, maximum score is 103. Mild 0 - 14 Moderate 15 - 39 Severe 40 - 103 The SCORAD before treatment was expected to be higher than after treatment. Outcome: change of SCORAD
Immunoglobulin E change
时间窗: 0, 8 weeks
Change of Immunoglobulin E
次要结局
- Interleukin-12 change(0, 8 weeks)
- Interleukin-4 change(0, 8 weeks)
- Interferon Gamma change(0, 8 weeks)