跳至主要内容
临床试验/CTRI/2019/07/020274
CTRI/2019/07/020274尚未招募不适用

Comparative efficacy of methotrexate, apremilast and their combination in psoriasis vulgaris.

Department of Dermatology1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年7月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
To compare the efficacy of apremilast and methotrexate and their combination in patients of psoriasis vulgaris by comparing the PASI score before and after commencement of the therapy.

研究概览

简要总结

Psoriasis is a common, chronic, non-contagious inflammatory skin disorder characterized by sharply demarcated, red plaques with silvery white scaling, which may occur on any part of the body but preferentially over extensor areas and scalp. While methotrexate is highly efficacious, the wide array of side effects restrict its use in the long term and mandate the need for strict periodical monitoring and a limited total cumulative dose. On the other hand, apremilast is a relatively safer drug but its efficacy in Indian population is not yet established. The present study aims to assess its efficacy and compare it with the gold standard, methotrexate. Since no single drug is completely effective in the treatment and maintenance of this chronic disease, the present study also aims to assess the efficacy of the combination of two drugs to ascertain if apremilast could enhance the efficacy of methotrexate, leading to less adverse effects, reduced dosage and duration of therapy of methotrexate.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients of psoriasis vulgaris requiring systemic therapy.
  • (Body surface area > 10% or PASI score > 10 or non-responsive to topical therapy)
  • Patients above the age of 18 years.
  • Patients consenting for contraception required for methotrexate therapy.

排除标准

  • Patients suffering from any other significant systemic illness.
  • History of anti-psoriatic treatment in the last 2 months.
  • Pregnant or lactating women.

结局指标

主要结局

To compare the efficacy of apremilast and methotrexate and their combination in patients of psoriasis vulgaris by comparing the PASI score before and after commencement of the therapy.

时间窗: 0,2,4,6,8 weeks.

次要结局

  • To assess the safety of all the three treatment modalities by assessing the side effects.(0,2,4,6,8 weeks.)

研究者

申办方类型
Government medical college

研究点 (1)

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