Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2026-01-02 @ 6:19 AM
Study NCT ID:
NCT06946069
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-27
First Post:
2025-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunomodulatory Effects of NB-UVB and Steroids in Vitiligo: A Study on CXCL11 and TEMRA Biomarkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014820', 'term': 'Vitiligo'}], 'ancestors': [{'id': 'D017496', 'term': 'Hypopigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a two-arm, parallel-group randomized controlled trial (RCT).\n\nParticipants are randomly assigned (1:1 ratio) to one of two treatment arms:\n\nNB-UVB monotherapy (control group).\n\nNB-UVB + oral mini-pulse (OMP) steroids (intervention group).\n\nBoth groups receive simultaneous but distinct interventions for direct comparison.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-19', 'studyFirstSubmitDate': '2025-04-19', 'studyFirstSubmitQcDate': '2025-04-19', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in serum CXCL11 & TEMRA levels', 'timeFrame': '6 months', 'description': 'Measured via ELISA before and after treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vitiligo', 'NB-UVB', 'CXCL11', 'TEMRA'], 'conditions': ['Vitiligo', 'NB-UVB']}, 'descriptionModule': {'briefSummary': 'this is a prospective, randomized controlled trial (RCT) investigating the immunological effects of narrowband UVB (NB-UVB) phototherapy-both as monotherapy and in combination with oral mini-pulse (OMP) steroids-in non-segmental vitiligo patients. The study evaluates changes in CXCL11 (a chemokine involved in T-cell recruitment) and TEMRA (terminally differentiated effector memory T cells re-expressing CD45RA) levels in serum before and after treatment.', 'detailedDescription': 'Design:\n\nRandomized controlled trial (RCT) with two parallel arms.\n\nDuration: Six months (including baseline and follow-up assessments).\n\nSetting: Outpatient dermatology clinic at Assiut University Hospital, Egypt.\n\nObjectives:\n\nCompare the immunomodulatory effects of NB-UVB alone vs. NB-UVB + OMP steroids in vitiligo patients.\n\nAssess CXCL11 and TEMRA levels as potential biomarkers for disease activity and treatment response.\n\nEvaluate clinical repigmentation using Vitiligo Extent Score (VES/VESplus).\n\nMethodology:\n\n40 patients with stable non-segmental vitiligo will be enrolled.\n\n20 patients will undergo serum analysis for CXCL11 and TEMRA via ELISA.\n\nTreatment arms:\n\nNB-UVB monotherapy (twice weekly).\n\nNB-UVB + OMP steroids (dexamethasone 2.5-3 mg/week).\n\nFollow-up: Clinical and immunological assessments at baseline and 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinically diagnosed non-segmental vitiligo (stable for ≥3 months).\n\nFitzpatrick skin types III-V (common in the Egyptian population).\n\nNo recent systemic therapy for vitiligo (within the last 3 months).\n\nExclusion Criteria:\n\nPhotosensitivity disorders (e.g., lupus, porphyria).\n\nPregnancy or breastfeeding.\n\nActive infections, malignancies, or immunosuppressive conditions.\n\nHistory of hypertrophic scarring or melanoma.'}, 'identificationModule': {'nctId': 'NCT06946069', 'briefTitle': 'Immunomodulatory Effects of NB-UVB and Steroids in Vitiligo: A Study on CXCL11 and TEMRA Biomarkers', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Expression of CXCL11 & TEMRA in Serum of Vitiligo Patients Treated With Narrow-band UVB', 'orgStudyIdInfo': {'id': 'Effects of NB-UVB and Steroids'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (NB-UVB Monotherapy)', 'description': 'Standard phototherapy without additional systemic treatment.', 'interventionNames': ['Radiation: NB-UVB twice weekly']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (NB-UVB + OMP Steroids)', 'description': 'Combination therapy of NB-UVB + OMP Steroids to enhance immunosuppression and repigmentation.', 'interventionNames': ['Other: NB-UVB + dexamethasone (2.5-3 mg/week)']}], 'interventions': [{'name': 'NB-UVB twice weekly', 'type': 'RADIATION', 'description': 'Standard phototherapy without additional systemic treatment.', 'armGroupLabels': ['Group 1 (NB-UVB Monotherapy)']}, {'name': 'NB-UVB + dexamethasone (2.5-3 mg/week)', 'type': 'OTHER', 'description': 'Combination therapy to enhance immunosuppression and repigmentation.', 'armGroupLabels': ['Group 2 (NB-UVB + OMP Steroids)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident at the dermatology Surgery department', 'investigatorFullName': 'ALZAHRA MOAHMED MOHAMED ABDELHAFEZ', 'investigatorAffiliation': 'Assiut University'}}}}