Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT04765267
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2021-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Micronutrients in Management of Symptomatic Oral Lichen Planus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017676', 'term': 'Lichen Planus, Oral'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D008010', 'term': 'Lichen Planus'}, {'id': 'D017512', 'term': 'Lichenoid Eruptions'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019287', 'term': 'Zinc Sulfate'}, {'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017967', 'term': 'Zinc Compounds'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-05', 'studyFirstSubmitDate': '2021-02-04', 'studyFirstSubmitQcDate': '2021-02-19', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain intensity', 'timeFrame': 'baseline (week 0), daily in week 1, week 1,week 2, week 3, week 4, week 5, week 6 and week 7', 'description': 'Visual analogue scale (0-10)'}], 'secondaryOutcomes': [{'measure': 'change in clinical improvement', 'timeFrame': 'baseline (week 0), week 1,week 2, week 3, week 4, week 5, week 6 and week 7', 'description': 'measured using Thongprasom et al. scoring system'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['micronutrients', 'topical corticosteroids'], 'conditions': ['Oral Lichen Planus']}, 'referencesModule': {'references': [{'pmid': '40457259', 'type': 'DERIVED', 'citation': 'Aboushousha A, Kamal Y, Ali S. Supplementary zinc and vitamin D in management of symptomatic oral lichen planus: a three-arm randomized clinical trial. BMC Oral Health. 2025 Jun 2;25(1):872. doi: 10.1186/s12903-025-06173-1.'}]}, 'descriptionModule': {'briefSummary': 'Treatment of oral lichen planus is challenging. Diverse therapeutic modalities have been suggested, but a permanent cure is not yet available. In some OLP patients, topical corticosteroid alone is not sufficiently enough, thus it may require a supplementation to augment its effect. Micronutrients are gaining more attention as therapeutic modalities in immunologic disorders. Researchers are recommended to conduct further clinical studies are to assess the role of these elements in management of OLP (Gholizadeh \\& Sheykhbahaei, 2020). Among the less visited micronutrients are zinc and vitamin D. This trial will assess their role in management of OLP.', 'detailedDescription': 'The enrolled patients will be divided randomly into three groups. One group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily, the second group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily with systemic zinc (Octozinc: Zinc sulphate heptahydrate 25 mg tablets - October Pharma) twice daily and the third group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily with systemic vitamin D (Cholecalciferol: vitamin D3 15 ml oral solution - Medical Union Pharmaceuticals) once daily. The patients will be recalled weekly for eight weeks. For every four weeks of topical corticosteroid application, topical oral antifungal (Daktarin 2% oral gel - miconazole) will be prescribed, four times daily for one week, to all the patients in the trial, to avoid secondary infection with oral candidiasis. The patients will be asked to prohibit the use of any topical or systemic medication during the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from erosive or atrophic OLP\n* Patients free from any visible oral lesions other than OLP.\n* Patients who agreed to take the supplied interventions.\n* Patient who will agree to participate in the study.\n* Patients who will accept to sign the informed consent.\n\nExclusion Criteria:\n\n* Patients suffering from any systemic disease.\n* Treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks.\n* Treatment with any oral topical medications for at least four weeks prior to the study.\n* Pregnant and lactating mothers.'}, 'identificationModule': {'nctId': 'NCT04765267', 'briefTitle': 'Micronutrients in Management of Symptomatic Oral Lichen Planus', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Micronutrients With Topical Corticosteroid Versus Topical Corticosteroid in Management of Symptomatic Oral Lichen Planus: Three-arm Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'OMED 3-7-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Topical Corticosteroid with Systemic Zinc.', 'description': 'Octozinc: Zinc sulphate heptahydrate 25 mg tablets - October Pharma', 'interventionNames': ['Dietary Supplement: Zinc sulphate heptahydrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Topical Corticosteroid with Systemic Vitamin D', 'description': 'Cholecalciferol: vitamin D3 15 ml oral solution - Medical Union Pharmaceuticals', 'interventionNames': ['Dietary Supplement: Zinc sulphate heptahydrate']}, {'type': 'OTHER', 'label': 'Topical Corticosteroid', 'description': 'Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm', 'interventionNames': ['Dietary Supplement: Zinc sulphate heptahydrate']}], 'interventions': [{'name': 'Zinc sulphate heptahydrate', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Cholecalciferol: vitamin D3 oral solution'], 'description': 'Dietary supplements', 'armGroupLabels': ['Topical Corticosteroid', 'Topical Corticosteroid with Systemic Vitamin D', 'Topical Corticosteroid with Systemic Zinc.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11728', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Alaa Shousha', 'investigatorAffiliation': 'Cairo University'}}}}