Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-01 @ 11:36 PM
Study NCT ID:
NCT06416566
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-Dose Enoxaparin in Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-14', 'studyFirstSubmitDate': '2024-05-10', 'studyFirstSubmitQcDate': '2024-05-14', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psoriatic Area and Severity Index score', 'timeFrame': 'weekly for 6 weeks and at follow up period of 6 weeks', 'description': 'The studied patients will be clinically evaluated weekly for 6 weeks and at follow up period; biweekly for 6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'Rationale:\n\n* Psoriasis is a chronic immune-mediated inflammatory skin disorder where T cells play a fundamental role in its pathogenesis.\n* Low molecular weight heparin has been reported to exert immunomodulatory effect at small doses through inhibition of T cells heparinase enzyme.\n* Low molecular weight heparin may have promising results for treatment of psoriasis.\n\nResearch question:\n\n* Can low molecular weight heparin be used safely for treatment of psoriasis with good outcome?\n* Is enoxaparin inhibitory effect on T cell heparinase enzyme responsible for its beneficial effect?\n\nHypothesis:\n\n* Low molecular weight heparin can achieve good results when used at small doses for treatment of psoriasis.\n* Heparin can exert immunomodulatory effect in psoriasis through inhibition of T cell heparinase enzyme.\n\nAIM OF WORK\n\n-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.\n\nObjectives:\n\n* To evaluate safety and efficacy of low molecular weight heparin at small dose for treatment of psoriasis.\n* Contribute to the ongoing efforts to optimize psoriasis management and improve the lives of individuals affected by this chronic condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with plaque psoriasis, who met the following criteria will be enrolled.\n\n 1. Age 18 and above.\n 2. No systemic (oral, parenteral, photobiological) treatment for psoriasis within the last 2 months.\n 3. No topical treatment for psoriasis within the last 2 weeks.\n\nExclusion Criteria:\n\n* 1\\. Pregnancy or lactation. 2. Hypersensitivity to heparin and heparin derivatives and a history of heparin-induced thrombocytopenia.\n\n 3\\. History of bleeding diathesis, uncontrolled hypertension, cerebrovascular accident, peptic ulcer, liver disease and/or abnormal liver function tests or abnormal kidney function tests.\n\n 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.'}, 'identificationModule': {'nctId': 'NCT06416566', 'briefTitle': 'Low-Dose Enoxaparin in Psoriasis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'The Efficacy of Low-Dose Enoxaparin in Psoriasis', 'orgStudyIdInfo': {'id': 'Enoxaparin in psoriasis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enoxaparin', 'description': 'will receive subcutaneous enoxaparin', 'interventionNames': ['Drug: Subcutaneous Enoxaparin']}], 'interventions': [{'name': 'Subcutaneous Enoxaparin', 'type': 'DRUG', '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', 'armGroupLabels': ['Enoxaparin']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nourhan Anis', 'role': 'CONTACT', 'email': 'norhan_hn_as@yahoo.com', 'phone': '+201149947355'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Norhan Anees', 'investigatorAffiliation': 'Zagazig University'}}}}