Crisaborole 2% Versus Tacrolimus 0.03% Ointments for the Treatment of Mild to Moderate Atopic Dermatitis: A Comparative Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Improvement of Investigator's Static Global Assessment score
研究概览
简要总结
This study will compare the efficacy and safety of crisaborole ointment with tacrolimus ointment, in the treatment of 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
- None
入排标准
- 年龄范围
- 5 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis of AD, according to Hanifin and Rajka criteria.
- •Patients of both genders
- •Age 5-25 years
- •Baseline Investigator's Static Global Assessment (ISGA) score of mild (2) or moderate (3).
排除标准
- •Clinically infected eczema.
- •Baseline Investigator's Static Global Assessment (ISGA) score of severe (4).
- •Associated comorbidities that exacerbate pruritus.
- •Patients receiving topical treatment for AD and/or pruritus within the past 14 days and/or systemic treatment within the past month.
- •Pregnancy and lactation if in the childbearing period
研究组 & 干预措施
Crisaborole ointment
干预措施: Application of crisaborole twice daily (Drug)
Tacrolimus ointment
干预措施: Tacrolimus ointment in atopic dermatitis (Drug)
结局指标
主要结局
Improvement of Investigator's Static Global Assessment score
时间窗: 3 months
1. Assessment of the \*\*Investigator's Static Global Assessment\*\* scores before and after treatment with crisaborole 2% ointment. 2. Assessment of the \*\*Investigator's Static Global Assessment\*\* before and after treatment with tacrolimus 0.03% ointment. 3. Comparison of the \*\*percentage of improvement\*\* in the \*\*Investigator's Static Global Assessment\*\* between the two treatment groups.
Improvement of Eczema Area and Severity Index
时间窗: 3 months
1. Assessment of \*\*Eczema Area and Severity Index\*\* scores before and after the use of \*\*crisaborole 2% ointment\*\*. 2. Assessment of \*\*Eczema Area and Severity Index\*\* scores before and after the use of \*\*tacrolimus 0.03% ointment\*\*. 3. Comparison of the percentage of improvement in the \*\*Eczema Area and Severity Index\*\* scores between the two treatment groups
次要结局
未报告次要终点