NCT00878670已完成4 期
Prospective Clinical Trial to Assess the Efficacy and Safety of EPOGAM 1000 in Patients With Atopic Dermatitis (Explorative Pilot Study)
Max Zeller Soehne AG4 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2009年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- Levels of dihomo-gamma linolic acid in the blood
研究概览
简要总结
In this study it will be investigated if patients with atopic dermatitis responding to EPOGAM treatment, show a significant increase of dihomo-gamma-linolic acid in the blood.
详细描述
Patients with atopic dermatitis will receive EPOGAM 1000 for 12 weeks. Clinical symptoms of the disease will be assessed using the SCORAD score. Dihomo-gamma-linolic acid levels in the blood will be measured with GC-MS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •atopic dermatitis since at least 2 months (criteria after Hanifin and Rajka, 1980)
- •men or women aged 2 - 45 years
- •women of childbearing age using contraception
- •informed consent of the patient or of the parents
排除标准
- •psychiatric disorder
- •abuse of drugs or alcohol
- •chronic dermatosis
- •glaucoma, cataract or ocular herpes simplex
- •Immune deficiency
- •Immunological diseases
- •clinical relevant changes in laboratory parameters
- •congenital diseases
- •scabies, infections with dermathophytae, HIV-associated dermatosis
- •malignant diseases
- •metabolic diseases
- •parasites
- •patients enrolled in other studies
- •progredient, systemic diseases
- •pregnancy and lactation
- •severe internistic diseases
- •organ transplantation in the medical history
- •hypersensitivity against an ingredient of the study medication
结局指标
主要结局
Levels of dihomo-gamma linolic acid in the blood
时间窗: 0, 4 and 12 weeks after start of treatment
Efficacy of EPOGAM 1000 treatment on the symptoms of atopic dermatitis
时间窗: 0, 4 and 12 weeks after start of treatment
次要结局
- Assessment of the efficacy of EPOGAM 1000 treatment by the patient on a visual analog scale(4 and 12 weeks after start of treatment)
- Assessment of the symptoms itching, sleep disorder, skin sensation, skin condition by the patient on a visual analog scale(4 and 12 weeks after start of treatment)
- Willingness of the patient to further take the medication and assessment of problems related to the intake of the study drug.(12 weeks after start of treatment)
- Assessment of the efficacy of EPOGAM treatment by the investigator(4 and 12 weeks after start of treatment)
- Assessment of adverse events (AE)(During treatment (12 weeks))
- Physical examination(0, 4 and 12 weeks after start of treatment)
- Laboratory values (blood examination)(0, 4 and 12 weeks after start of the treatment)
研究者
研究点 (4)
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