A Comparative Clinical Trial Evaluating the Effect and Safety of Tacrolimus Versus Hydrocortisone in Management of Atopic Dermatitis in Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the impact of topical tacrolimus ointment to topical hydrocortisone cream by measuring inflammatory cytokine levels in the blood.
研究概览
简要总结
One of the most frequent skin conditions is atopic dermatitis (AD), characterized by its pruritic inflammation effect. Where the prevalence of AD increased in the last three decades by two or three folds worldwide, especially in developed countries, AD is supposed to affect about 15% to 30% of children, and 2% to 10% of adults. This type of dermatitis is frequently linked to a family history of other atopic illnesses such as allergic rhinitis or asthma.
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
- Double (Participant, Investigator)
盲法说明
double-blinded
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 2-16 years old AD patients.
排除标准
- •patients diagnosed with other skin disorders of serious type and who are taking systemic corticosteroids or anti-inflammatory medications.
研究组 & 干预措施
Tacrolimus Group
50 patients will be treated with a thin layer of 0.03% topical tacrolimus ointment on the affected areas twice daily for 4 months.
干预措施: Tacrolimus ointment (Drug)
Hydrocortisone Group
50 patients will be treated with a thin layer of 1% hydrocortisone cream on the affected areas twice daily for 4 months.
干预措施: Hydrocortisone 1% cream (Drug)
结局指标
主要结局
To compare the impact of topical tacrolimus ointment to topical hydrocortisone cream by measuring inflammatory cytokine levels in the blood.
时间窗: 4 months
To compare the impact of topical tacrolimus ointment to topical hydrocortisone cream by measuring inflammatory cytokine levels in the blood such as interleukin-6 (IL-6), and IL-10.
次要结局
未报告次要终点
研究者
Mostafa Bahaa
Teaching Assistant
Tanta University