PsoriasisNCT06416566
Low-Dose Enoxaparin in Psoriasis
A study testing Subcutaneous Enoxaparin in people with Psoriasis, run by Zagazig University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Subcutaneous Enoxaparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2024to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Efficacy of Low-Dose Enoxaparin in Psoriasis
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.
Read more
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
- Being tested
- Subcutaneous Enoxaparin
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous EnoxaparinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Enoxaparin | Experimental | will receive subcutaneous enoxaparin Receives: Drug: Subcutaneous Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: weekly for 6 weeks and at follow up period of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start15 May 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Norhan Anees, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416566
- Sponsor's protocol ID
- Enoxaparin in psoriasis
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Low-Dose Enoxaparin in Psoriasis
- ClinicalTrials.gov ID
- NCT06416566
- Acronym / sponsor ID
- Enoxaparin in psoriasis
- Conditions
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enoxaparin | Experimental | Drug: Subcutaneous Enoxaparinwill receive subcutaneous enoxaparin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with plaque psoriasis, who met the following criteria will be enrolled.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcutaneous EnoxaparinSelected 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 | Drug | Enoxaparin |
Primary outcome
Psoriatic Area and Severity Index score
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous Enoxaparin in people with Psoriasis, run by Zagazig University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nourhan Anis (+201149947355, norhan_hn_as@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriatic Area and Severity Index score (time frame: weekly for 6 weeks and at follow up period of 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.