Efficacy and Safety of Crisaborole 2% Versus Tacrolimus 0.1% in Children With Mild to Moderate Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Proportion of Participants with ISGA sucess ( clear / almost clear from baseline) at day 28.
研究概览
简要总结
This randomized, open-label, parallel-group study will compare the efficacy and safety of Crisaborole 2% ointment and Tacrolimus 0.1% ointment in children with mild to moderate atopic dermatitis. A total of 66 participants will be randomized (1:1) to receive either Crisaborole or Tacrolimus, applied twice daily to affected areas for 28 days. Primary endpoint is proportion of participants achieving Investigator's Static Global Assessment (ISGA) success (clear/almost clear with ≥2-point improvement from baseline) at Day 28. Safety assessments include adverse events and local application site reactions.
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
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2-18 years Both genders Clinically diagnosed mild to moderate atopic dermatitis Body surface area (BSA) <30%
排除标准
- •Active viral, bacterial, or fungal skin infection at the treatment site
- •Recent use of topical corticosteroids, calcineurin inhibitors, PDE4 inhibitors, or immunosuppressive medication within past 2 weeks
- •Known hypersensitivity to study medications or components
- •Chronic inflammatory conditions (e.g., psoriasis and seborrheic dermatitis) that may interfere with evaluation
研究组 & 干预措施
Crisaborole 2% Ointment
Twice daily application to affected areas for 28 days
干预措施: Crisaborole 2% (Drug)
Tacrolimus 0.1% Ointment
Twice daily application to affected areas for 28 days
干预措施: Tacrolimus 0.1% (Drug)
结局指标
主要结局
Proportion of Participants with ISGA sucess ( clear / almost clear from baseline) at day 28.
时间窗: 28 days
Change in ISGA from baseline to day 28.
时间窗: Baseline, Day 14, Day 28
ISGA uses a 5-point scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe); negative change indicates improvement.
次要结局
未报告次要终点
研究者
Kheziema Maryum
Principal Investigator
Shalamar Institute of Health Sciences