Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-27 @ 6:21 PM
Study NCT ID:
NCT00421161
Status:
UNKNOWN
Last Update Posted:
2007-01-11
First Post:
2007-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Olive Oil With Omega 3 to Treat Stasis Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003872', 'term': 'Dermatitis'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069463', 'term': 'Olive Oil'}, {'id': 'D004281', 'term': 'Docosahexaenoic Acids'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2007-03'}, 'lastUpdateSubmitDate': '2007-01-10', 'studyFirstSubmitDate': '2007-01-10', 'studyFirstSubmitQcDate': '2007-01-10', 'lastUpdatePostDateStruct': {'date': '2007-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement in subjective and objective skin changes of patient: pain, edema, redness, size of involement,'}]}, 'conditionsModule': {'keywords': ['olive oil', 'stasis dermatitis', 'Patients with stasis dermatitis for at least six months.'], 'conditions': ['Dermatitis']}, 'referencesModule': {'references': [{'pmid': '16130045', 'type': 'BACKGROUND', 'citation': 'Sapino S, Carlotti ME, Peira E, Gallarate M. Hemp-seed and olive oils: their stability against oxidation and use in O/W emulsions. J Cosmet Sci. 2005 Jul-Aug;56(4):227-51.'}]}, 'descriptionModule': {'briefSummary': 'Olive oil and Omega 3 have many anti inflammatory effects that may be beneficial in the inflammation and edema of chronic stasis dermatitis. The olive oil contains many mono unsaturated fatty acids and anti oxidants that may add to the well being of a diseased skin by improving cell membrane homeostasis.', 'detailedDescription': 'Patients with chronic stasis dermatitis due to venous insufficiency will be treated with the study cream and as control we will use "Venoroutone" . Patients will be followed weekly at the clinic of the vascular surgery at Assaf Harofeh MC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patints with stasis dermatitis for 6 months at least\n\nExclusion Criteria:\n\n* skin ulceration or infection'}, 'identificationModule': {'nctId': 'NCT00421161', 'briefTitle': 'Olive Oil With Omega 3 to Treat Stasis Dermatitis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Phase 1 and 2 Study on the Efficacy and Side Effects of Olive Oil and Omega 3 Local Treatment in Stasis Dermatitis', 'orgStudyIdInfo': {'id': 'Refael Segal'}}, 'armsInterventionsModule': {'interventions': [{'name': 'olive oil and omega 3 in a combined cream', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70300', 'city': 'Ẕerifin', 'state': 'Beer Yaacov', 'country': 'Israel', 'contacts': [{'name': 'Refael Segal, MD', 'role': 'CONTACT', 'email': 'rsegal@post.tau.ac.il', 'phone': '972-8-9258640-3'}, {'name': 'Arie Bas, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Assaf Harofe MC', 'geoPoint': {'lat': 31.95731, 'lon': 34.84852}}, {'zip': '70300', 'city': 'Ẕerifin', 'state': 'Zerifin', 'country': 'Israel', 'contacts': [{'name': 'Arie Bass, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinic of vascular surgery, Assaf Harofe MC', 'geoPoint': {'lat': 31.95731, 'lon': 34.84852}}, {'zip': '70300', 'city': 'Ẕerifin', 'state': 'Zerifin', 'country': 'Israel', 'contacts': [{'name': 'Refael Segal, MD', 'role': 'CONTACT', 'email': 'rsegal@post.tau.ac.il', 'phone': '972-8-9258640-3'}], 'facility': 'Clinic of Vascular Surgery', 'geoPoint': {'lat': 31.95731, 'lon': 34.84852}}], 'centralContacts': [{'name': "Refael Segal, MD, Prof'", 'role': 'CONTACT', 'email': 'rsegal@post.tau.ac.il', 'phone': '972-8-9258640-3'}, {'name': 'Arie Bas, MD, Prof', 'role': 'CONTACT', 'email': 'arbas@post.tau.ac.il', 'phone': '972-8-9779188'}], 'overallOfficials': [{'name': 'Arie Bass, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assaf Harofe MC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}}}}