## Protocol Section
### Identification Module
**NCT ID:** NCT06416566

**Brief Title:** Low-Dose Enoxaparin in Psoriasis

**Official Title:** The Efficacy of Low-Dose Enoxaparin in Psoriasis

#### Organization Study ID Info
**ID:** Enoxaparin in psoriasis
#### Organization
**Class:** OTHER_GOV
**Full Name:** Zagazig University
### Status Module
#### Completion Date
**Date:** 2024-10-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Zagazig University

#### Responsible Party

**Investigator Affiliation:** Zagazig University

**Investigator Full Name:** Norhan Anees

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Psoriasis

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** will receive subcutaneous enoxaparin

**Intervention Names:**

- Drug: Subcutaneous Enoxaparin

**Label:** Enoxaparin

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Enoxaparin

**Description:** 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

**Name:** Subcutaneous Enoxaparin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The studied patients will be clinically evaluated weekly for 6 weeks and at follow up period; biweekly for 6 weeks

**Measure:** Psoriatic Area and Severity Index score

**Time Frame:** weekly for 6 weeks and at follow up period of 6 weeks

### Eligibility Module

**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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** norhan_hn_as@yahoo.com

**Name:** Nourhan Anis

**Phone:** +201149947355

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000017444

- Term: Skin Diseases, Papulosquamous

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14422

- Name: Psoriasis

- Relevance: HIGH

- As Found: Psoriasis

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19713

- Name: Skin Diseases, Papulosquamous

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011565

- Term: Psoriasis

### Intervention Browse Module - Ancestors

- ID: D000000925

- Term: Anticoagulants

- ID: D000005343

- Term: Fibrinolytic Agents

- ID: D000050299

- Term: Fibrin Modulating Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: FiAg

- Name: Fibrinolytic Agents

- Abbrev: AnCoag

- Name: Anticoagulants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M20152

- Name: Enoxaparin

- Relevance: HIGH

- As Found: Fast

- ID: M137075

- Name: Enoxaparin sodium

- Relevance: LOW

- As Found: Unknown

- ID: M4244

- Name: Anticoagulants

- Relevance: LOW

- As Found: Unknown

- ID: M8473

- Name: Fibrinolytic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000017984

- Term: Enoxaparin

### Misc Info Module

- Version Holder: 2024-05-31
