NCT06416566尚未招募不适用
The Efficacy of Low-Dose Enoxaparin in Psoriasis
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
- 否
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
Norhan Anees
Principal Investigator
Zagazig University
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