CTRI/2025/11/096803尚未招募不适用
A Double Blind Randomized Study To Evaluate Safety And Efficacy Of Tofacitinib And Crisaborole For Topical Management Of Mild To Moderate Atopic Eczema
School of Tropical Medicine,Kolkata1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年11月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To compare safety and efficacy of Tofacitinib and Crisaborole for topical management of mild to moderate Atopic Eczema
研究概览
简要总结
This study is a double blind ,parallel group randomized trial to be conducted in Department of Dermatology, School of Tropical medicine ,Kolkata to compare the safety and efficacy of Tofacitinib and Crisaborole for topical management of mild to moderate eczema for 6 weeks (follow up done every 2 weeks) in 64 patients. The primary outcome measures the safety and efficacy of these drugs for management of Atopic eczema . Secondary outcomes measures how effective these drugs can be as a long term alternative to Topical steroids free maintenance therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All cases of mild to moderate Atopic eczema.
排除标准
- •Patient unwilling to participate 2) Severe Atopic Eczema 3) Active forms of other eczematous or dermatitis, history of disseminated or recurrent herpes zoster infection 4) Severely ill patients requiring hospitalization less than 6 months prior to the study 5) Any active infection 6) On treatment -oral or topical less than 2 weeks prior to the study 7) History of lymphoproliferative disorders or malignancies.
结局指标
主要结局
To compare safety and efficacy of Tofacitinib and Crisaborole for topical management of mild to moderate Atopic Eczema
时间窗: 6 weeks
次要结局
- To evaluate an effective long term steroid free topical maintenance therapy for management of mild to moderate eczema(6 weeks)
研究者
Dr Rubina Sultana
School of Tropical Medicine
研究点 (1)
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