CTRI/2022/01/039139尚未招募4 期
Efficacy and Tolerability of Oral Apremilast VS Oral Methotrexate in Interface dermatitis- A Randomized study
Krishna institute of medical sciences karad1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年1月13日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Decrease in body surface area covered by skin lesions
研究概览
简要总结
Study titled ‘ Efficacy and tolerability of Oral Apremilast VS Oral Methotrexate in interface dermatitis - A Randomized Study’ aims to compare the efficacy and safety profile of the above mentioned drugs in the treatment of interface dermatitis.
Oral methotrexate is currently the gold standard treatment for diseases showing interface dermatitis patterns.
Oral Apremilast is proven to have fewer adverse effects than methotrexate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 14.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with disorders which has been proven to be interface dermatitis on Histopathological examination
- •Histopathological examination showing interface dermatitis type 2-5according to Le Boit PE classification (9)
- •Have completed 14 years of age.(7)
- •Have not taken any treatment, two months prior to the inclusion in study.
- •Have given written consent before investigation
- •Be able and willing , in the view of investigator , to comply all study procedures.
排除标准
- •Patients with interface dermatitis type 1, according to Le Boit PE classification(9)
- •Patients with interface dermatitis not requiring systemic management
- •Hemoglobin < 8 gm/dl ,Total leukocyte count < 3500/ mm3, Platelet count < 100,000/mm3
- •Elevation of hepatic enzymes (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) to more than twice the upper limit of normal or any deranged liver function tests.
- •Use of other hepatotoxic drugs by the patient
- •Positive hepatitis B, hepatitis C or HIV serology
- •Pulmonary or extra-pulmonary active tuberculosis
- •Deranged renal function test.
- •Pregnancy or lactation or if patient is planning to conceive during the treatment period.
- •Patient on other immunosuppressive drugs
- •Recent live vaccination
- •Unreliable patient
- •Patients unwilling for monthly follow-ups.
- •Patient with unrealistic expectation.
结局指标
主要结局
Decrease in body surface area covered by skin lesions
时间窗: Baseline | 2 weeks | 4 weeks | 8 weeks | 12 weeks
Improvement in PGA scores
时间窗: Baseline | 2 weeks | 4 weeks | 8 weeks | 12 weeks
次要结局
- Oral Apremilast having same or better efficacy and safety profile than oral Methotrexate in the treatment of interface dermatitis(3 months)
研究者
研究点 (1)
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