Evaluation of the Value of Adding Azithromycin to Topical Treatment in Mild to Moderate Atopic Dermatitis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement in Eczema Area and Severity Index (EASI)
研究概览
简要总结
The study will evaluate the role of adding azithromycin to topical treatment in patients with mild to moderate atopic dermatitis
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 (Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders, ages from 3 to 12 years old with mild to moderate atopic dermatitis
排除标准
- •Atopic dermatitis on active systemic treatment
结局指标
主要结局
Improvement in Eczema Area and Severity Index (EASI)
时间窗: 3 months
The primary outcome will be the change in the Eczema Area and Severity Index (EASI) score from baseline to the end of the treatment period. The EASI is a validated clinician-assessed tool that evaluates the severity and extent of atopic dermatitis by assessing erythema, edema/papulation, excoriation, and lichenification across four body regions. Scores range from 0 to 72, with higher scores indicating more severe disease. Outcome variable: Mean change in EASI score from baseline. Assessment time points: Baseline, Week 2, Week 4, Week 8, and end of follow-up. Treatment response: Proportion of patients achieving EASI-50, EASI-75, and EASI-90 (≥50%, ≥75%, and ≥90% improvement from baseline).
次要结局
- Investigator's Global Assessment (IGA)(4 months)
- Pruritus Severity(3)