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临床试验/NCT06416566
NCT06416566尚未招募不适用

The Efficacy of Low-Dose Enoxaparin in Psoriasis

Zagazig University0 个研究点目标入组 30 人开始时间: 2024年5月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Psoriatic Area and Severity Index score

研究概览

简要总结

Rationale:

  • Psoriasis is a chronic immune-mediated inflammatory skin disorder where T cells play a fundamental role in its pathogenesis.
  • Low molecular weight heparin has been reported to exert immunomodulatory effect at small doses through inhibition of T cells heparinase enzyme.
  • Low molecular weight heparin may have promising results for treatment of psoriasis.

Research question:

  • Can low molecular weight heparin be used safely for treatment of psoriasis with good outcome?
  • Is enoxaparin inhibitory effect on T cell heparinase enzyme responsible for its beneficial effect?

Hypothesis:

  • Low molecular weight heparin can achieve good results when used at small doses for treatment of psoriasis.
  • Heparin can exert immunomodulatory effect in psoriasis through inhibition of T cell heparinase enzyme.

AIM OF WORK

-The aim of this work is to assess the possible clinical efficacy and safety of low-dose enoxaparin in the treatment of psoriasis and to detect if inhibition of heparinase enzyme might account for its beneficial therapeutic effect.

Objectives:

  • To evaluate safety and efficacy of low molecular weight heparin at small dose for treatment of psoriasis.
  • Contribute to the ongoing efforts to optimize psoriasis management and improve the lives of individuals affected by this chronic condition.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with plaque psoriasis, who met the following criteria will be enrolled.
  • Age 18 and above.
  • No systemic (oral, parenteral, photobiological) treatment for psoriasis within the last 2 months.
  • No topical treatment for psoriasis within the last 2 weeks.

排除标准

  • Pregnancy or lactation.
  • Hypersensitivity to heparin and heparin derivatives and a history of heparin-induced thrombocytopenia.
  • History of bleeding diathesis, uncontrolled hypertension, cerebrovascular accident, peptic ulcer, liver disease and/or abnormal liver function tests or abnormal kidney function tests.
  • History of major surgery within the last 3 months.
  • A family history of bleeding diathesis, or cerebrovascular accident.
  • Concomitant use of oral anticoagulants, acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs.

研究组 & 干预措施

Enoxaparin

Experimental

will receive subcutaneous enoxaparin

干预措施: Subcutaneous Enoxaparin (Drug)

结局指标

主要结局

Psoriatic Area and Severity Index score

时间窗: weekly for 6 weeks and at follow up period of 6 weeks

The studied patients will be clinically evaluated weekly for 6 weeks and at follow up period; biweekly for 6 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Norhan Anees

Principal Investigator

Zagazig University

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