Low-Dose Enoxaparin in Psoriasis

Psoriasis Clinical Trial

Official title:

The Efficacy of Low-Dose Enoxaparin in Psoriasis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06416566
• Other study ID #: Enoxaparin in psoriasis
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: May 2024
• Source: Zagazig University
• Contact: Nourhan Anis
• Phone: +201149947355
• Email: norhan_hn_as[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psoriatic Area and Severity Index score	The studied patients will be clinically evaluated weekly for 6 weeks and at follow up period; biweekly for 6 weeks	weekly for 6 weeks and at follow up period of 6 weeks