Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 11:20 PM
Study NCT ID:
NCT01447693
Status:
UNKNOWN
Last Update Posted:
2011-10-06
First Post:
2007-12-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Uremic Pruritus by Olive-omega 3 Ointment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014511', 'term': 'Uremia'}, {'id': 'D011537', 'term': 'Pruritus'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'lastUpdateSubmitDate': '2011-10-05', 'studyFirstSubmitDate': '2007-12-31', 'studyFirstSubmitQcDate': '2011-10-05', 'lastUpdatePostDateStruct': {'date': '2011-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-06', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['uremia', 'pruritus', 'oliva-omega 3'], 'conditions': ['Uremic Pruritus']}, 'descriptionModule': {'briefSummary': "Background.\n\nUremic pruritus is still a common phenomenon in patients with end-stage renal failure. It is regarded as one of the most bothersome symptoms in patients on chronic dialysis.\n\nThe pathogenesis of uremic itch remains unclear. Several theories have been proposed like dryness of the skin, imbalance in divalent ions, peripheral neuropathy and others.\n\nMany treatment modalities have been tried to reduce uremic pruritus, however , the majority of them produced only temporary improvement. Therefore , every new therapeutic option for uremic pruritus is desirable.\n\nThis study will undertaken to evaluate the efficacy of a cream which included olive oil and omega-3 fatty acids.\n\nOlive Omega-3 is an efficient product that soothes itchiness of cracked and very dry skin.\n\nThe product is unique and based on patented technology developed by the Technion Research and Development Foundation in Haifa.\n\nOlive Omega-3 is an ointment composed of all natural ingredients. The main active ingredients are extra virgin olive oil , fish oil and vitamin C. The oils provides the skin with fatty acids that are vital for its proper functioning and help in the skin recovery. Sugar cane extract improves the skin's flexibility by removing dead cells and enhancing water retention in the upper layer of the skin.\n\nWhen applied on clean skin , the product is quickly absorbed , producing a sensation of relief within a short time period. Treatment can be repeated as often as required with no limitations and its use is not contraindicative of any other medical treatment.\n\nPatients and Methods.\n\nAbout 20 patients on chronic hemodialysis suffering from uremic pruritus will be include in the study.\n\nAll patients will undergo dermatologic examination. All patients will be score by intensity of itching according to 3-point scale , as follows:\n\n1. \\- patches of fine , powdery scales\n2. \\- moderate scaling with beginning cracks\n3. \\- intense scaling , moderate cracks The patients all applied Olive Omega-3 ointment for 50% of body and Vaseline ointment for the second one. The treatment will repeated twice daily for two weeks.\n\nAt the end of 2 weeks application global tolerance will evaluate using the following 3-point scale:\n\n1. very good\n2. good\n3. poor\n\nAt the same time global agreement of the patients will evaluate according to the following scale :\n\n1. \\- very satisfactory\n2. \\- satisfactory 3- poorly satisfactory.\n\nStatistical analysis will be performed by use of Wilcoxon test ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hemodialysis patients which have treated at least 3 months\n\nExclusion Criteria:\n\n* Dermatologic diseases'}, 'identificationModule': {'nctId': 'NCT01447693', 'briefTitle': 'Treatment of Uremic Pruritus by Olive-omega 3 Ointment', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'orgStudyIdInfo': {'id': '130/06'}}, 'armsInterventionsModule': {'interventions': [{'name': 'application of ointment (olive-omega 3 ointment)', 'type': 'PROCEDURE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}}}}