Low-Dose Enoxaparin in Psoriasis

Not Applicable

Not yet recruiting

• Conditions: Psoriasis
• Interventions: Drug: Subcutaneous Enoxaparin

• Registration Number: NCT06416566
• Lead Sponsor: Zagazig University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-14
• Last Update Submitted: 2024-05-14
• Study Start: 2024-05-15
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16
• Primary Completion: 2024-09-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with plaque psoriasis, who met the following criteria will be enrolled.

  1. Age 18 and above.
  2. No systemic (oral, parenteral, photobiological) treatment for psoriasis within the last 2 months.
  3. No topical treatment for psoriasis within the last 2 weeks.

Exclusion Criteria

• 1. Pregnancy or lactation. 2. Hypersensitivity to heparin and heparin derivatives and a history of heparin-induced thrombocytopenia.

  2. History of bleeding diathesis, uncontrolled hypertension, cerebrovascular accident, peptic ulcer, liver disease and/or abnormal liver function tests or abnormal kidney function tests.

  3. History of major surgery within the last 3 months. 5. A family history of bleeding diathesis, or cerebrovascular accident. 6. Concomitant use of oral anticoagulants, acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enoxaparin	Subcutaneous Enoxaparin	will receive subcutaneous enoxaparin

Primary Outcome Measures

Name	Time	Method
Psoriatic Area and Severity Index score	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