Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-01 @ 2:36 PM
Study NCT ID:
NCT06974669
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-16
First Post:
2025-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Value of Using Mini-oral Pulse Steroid Therapy Along With Non Cultured Epidermal Cell Suspension (NCES) in Stable Resistant Vitiligo
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2025-05-08', 'studyFirstSubmitQcDate': '2025-05-08', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparing percent change in pigmentation in both arms', 'timeFrame': '3 months', 'description': '• Comparing percent change of pigmentation as per VESTA score after 3 months of treatment with NCES with and without mini oral pulse steroids.'}, {'measure': 'comparing percent change in surface area in both arms', 'timeFrame': '3 months', 'description': '• Comparing percent change in the surface area of the depigmented patch following NCES using point counting technique.'}], 'secondaryOutcomes': [{'measure': 'comparing physician global assessment in both arms', 'timeFrame': '3 months', 'description': '• Comparing physician global assessment after treatment with NCES with and without oral mini-pulse therapy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vitiligo', 'surgery', 'mini-oral pulse steroid therapy', 'resistant'], 'conditions': ['Vitiligo']}, 'descriptionModule': {'briefSummary': 'Assessing the additive value of mini-oral pulse steroid therapy in surgical treatment of acral and difficult to treat sites of vitiligo'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with non-segmental vitiligo (NSV) with acral or resistant lesions over the elbows and knees, that has not responded to conventional treatment\n* Stability for ≥ 1 year\n* Age ≥18 years\n* Lack of topical treatment for at least 1 month prior to surgery and systemic treatment for at least 3 months prior to surgery.\n\nExclusion Criteria:\n\n* Non acral NSV responsive to conventional treatment modalities\n* Active vitiligo; new lesions, expansion of old lesions, confetti like lesions, ill-defined edges or koebnerization in \\< 1 year\n* Age \\< 18 years.\n* Pregnant females.\n* Patients with hypertension, diabetes or tuberculosis\n* Topical treatment in the past month and systemic treatment in the past 3 months.'}, 'identificationModule': {'nctId': 'NCT06974669', 'acronym': 'NCES', 'briefTitle': 'The Value of Using Mini-oral Pulse Steroid Therapy Along With Non Cultured Epidermal Cell Suspension (NCES) in Stable Resistant Vitiligo', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Value of Using Mini-oral Pulse Steroid Therapy Along With Non Cultured Epidermal Cell Suspension in Stable Resistant Vitiligo: An Interventional Prospective Controlled Trial.', 'orgStudyIdInfo': {'id': 'VS-OMP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vitiligo surgery with added mini-oral pulse steroid therapy in the peri-surgical period', 'description': 'this group will receive oral mini-pulse steroids (low-dose dexamethasone: 5mg/week on 2 successive days per week) for 2 weeks prior to NCES and for 4 weeks afterwards', 'interventionNames': ['Drug: oral steroid-dexamethasone', 'Procedure: non cultured epidermal suspension']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitiligo surgery without mini-oral pulse steroid therapy', 'description': 'this group will undergo None cultured epidermal suspension (NCES) without oral mini-pulse steroids.', 'interventionNames': ['Procedure: non cultured epidermal suspension']}], 'interventions': [{'name': 'oral steroid-dexamethasone', 'type': 'DRUG', 'description': 'this study is the first according to the best of our knowledge assessing the value of adding mini oral pulse steroid therapy to non cultured epidermal suspension in treatment of stable acral and difficult to treat vitiligo', 'armGroupLabels': ['Vitiligo surgery with added mini-oral pulse steroid therapy in the peri-surgical period']}, {'name': 'non cultured epidermal suspension', 'type': 'PROCEDURE', 'description': 'this is the best surgical technique for surgical treatment of vitiligo that would be done for both arms', 'armGroupLabels': ['Vitiligo surgery with added mini-oral pulse steroid therapy in the peri-surgical period', 'Vitiligo surgery without mini-oral pulse steroid therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12655', 'city': 'Giza', 'country': 'Egypt', 'contacts': [{'name': 'Rania Mogawer', 'role': 'CONTACT', 'phone': '106816339'}], 'facility': 'Dermatology Department, Cairo University Hospitals', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Dr. Mogawer, MD, PhD', 'role': 'CONTACT', 'email': 'raniamogawer@kasralainy.edu.eg', 'phone': '+20106815330'}, {'name': 'Prof. Nanis Ragab, MD, PhD', 'role': 'CONTACT', 'email': 'nanisragab@kasralainy.edu.eg', 'phone': '+201227449161'}], 'overallOfficials': [{'name': 'Dr. Mogawer, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dermatology Department, Cairo University Hopsitals'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'within 3 months and for 12 months after completion of the study', 'ipdSharing': 'YES', 'description': "Participants' data that underlie reported results will be shared upon request, after deidentification", 'accessCriteria': 'Controlled Access:\n\nResearchers who provide a methodologically sound proposal will be allowed to access data to achieve aims in the approved proposal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Dermatology', 'investigatorFullName': 'Rania Mogawer', 'investigatorAffiliation': 'Cairo University'}}}}