Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT03526705
Status:
UNKNOWN
Last Update Posted:
2019-07-23
First Post:
2018-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of NB-UVB on Interleukin-36 Levels 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': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-20', 'studyFirstSubmitDate': '2018-05-04', 'studyFirstSubmitQcDate': '2018-05-04', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in Il-36 levels in 25 psoriasis patients after 26 sessions of NB-UVB', 'timeFrame': '6 months', 'description': 'primary'}], 'secondaryOutcomes': [{'measure': 'changes in cathepsin G levels in 25 psoriasis patients after 26 sessions of NB-UVB psoriasis', 'timeFrame': '6 months', 'description': 'secondary'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'Psoriasis is an immune-mediated skin disease that affects 1-2 % of the population. Several cytokines have been found to be involved in the complex pathogenesis of this disease. Il- 36 is one of the cytokines sharing in psoriasis pathogenesis, as its levels are elevated in psoriatic plaques. Cathepsin G is known to activate Il- 36 and promote inflammation in psoriasis.NB-UVB is one of the important treatment modalities for psoriasis.\n\nThe aim of this study is to detect the effect of NB-UVB on the lesional levels of IL-36 in psoriasis.', 'detailedDescription': '25 psoriasis patients will receive 26 sessions of phototherapy (NB-UVB). Patients will receive 3 sessions per week. Tissue levels of IL-36 and Cathepsin G will be assessed in skin lesions before starting treatment and after completing the 26 sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with psoriasis vulgaris of both sexes\n* Age between 18 and 60 years old.\n\nExclusion Criteria:\n\n* Pregnant females\n* Patients receiving systemic treatment or topical treatment for psoriasis within the past two months.\n* Patients having other dermatological diseases.'}, 'identificationModule': {'nctId': 'NCT03526705', 'briefTitle': 'The Effect of NB-UVB on Interleukin-36 Levels in Psoriasis', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Effect of NB-UVB on Interleukin-36 Levels in Psoriasis Lesional Skin', 'orgStudyIdInfo': {'id': 'Kapu1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nb-uvb', 'description': 'psoriasis patients will receive 26 sessions of nb-uvb phototherapy', 'interventionNames': ['Device: NB-UVB']}], 'interventions': [{'name': 'NB-UVB', 'type': 'DEVICE', 'description': 'Phototherapy', 'armGroupLabels': ['nb-uvb']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Dina Saadi', 'investigatorAffiliation': 'Cairo University'}}}}