Low-Dose Enoxaparin in Psoriasis

NCT ID: NCT06416566

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-15
• Study Completion Date: 2024-10-01

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.

Conditions

Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enoxaparin

will receive subcutaneous enoxaparin

Group Type: EXPERIMENTAL

Subcutaneous Enoxaparin

Intervention Type: DRUG

Selected patients will receive subcutaneous low dose enoxaparin once a week for 6 weeks.The level of serum heparinase enzyme will be measured before and after treatment

Interventions

Subcutaneous Enoxaparin

Selected patients will receive subcutaneous low dose enoxaparin once a week for 6 weeks.The level of serum heparinase enzyme will be measured before and after treatment

Intervention Type: DRUG

Eligibility Criteria

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.

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

4. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Norhan Anees

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Nourhan Anis

Role: CONTACT

norhan_hn_as@yahoo.com

+201149947355

Other Identifiers

Enoxaparin in psoriasis

Identifier Type: -

Identifier Source: org_study_id