Low-Dose Enoxaparin in Psoriasis

NCT06416566 | Not Yet Recruiting DMC

• 1 other identifier: Enoxaparin in psoriasis
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Enoxaparin

EXPERIMENTAL

will receive subcutaneous enoxaparin

Drug: Subcutaneous Enoxaparin

Interventions

Subcutaneous Enoxaparin 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

Enoxaparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Pregnancy or lactation. 2. 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. 5. A family history of bleeding diathesis, or cerebrovascular accident. 6. Concomitant use of oral anticoagulants, acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs.

Sponsors & Collaborators

• Zagazig University: lead

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Nourhan Anis

CONTACT

+201149947355; norhan_hn_as@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: May 15, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05