Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-02 @ 11:11 PM
Study NCT ID:
NCT06362005
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-29
First Post:
2024-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of 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': 'D014222', 'term': 'Triamcinolone Acetonide'}, {'id': 'D009824', 'term': 'Ointments'}, {'id': 'D012643', 'term': 'Selenium'}], 'ancestors': [{'id': 'D014221', 'term': 'Triamcinolone'}, {'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'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-27', 'studyFirstSubmitDate': '2024-03-27', 'studyFirstSubmitQcDate': '2024-04-08', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to assess a visual analog scale (VAS)of the oral lichen planus lesion', 'timeFrame': 'baseline, 1, 3 and 6 months after treatment', 'description': 'qualitative'}], 'secondaryOutcomes': [{'measure': 'to assess The associated Oral Disease Severity Score 3- Glutathione biomarker level as an antioxidant enzyme in saliva by ELISA analysis', 'timeFrame': 'baseline, 1, 3 and 6 months after treatment', 'description': 'qualitative ,and quantitiave'}, {'measure': 'Biochemical evaluation of salivary Glutathione level using (ELISA)', 'timeFrame': 'baseline, 1, 3 and 6 months after treatment', 'description': 'Quantity'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['seleinum', 'Antioxidant', 'Glutathione-S-transferases', 'Reactive oxygen species'], 'conditions': ['Lichen Planus, Oral']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://orcid.org/my-orcid?orcid=0000-0002-8404-438X', 'label': 'Orchid'}, {'url': 'https://www.ncbi.nlm.nih.gov/myncbi/shaymaa.kotb.1/cv/655768', 'label': 'ncbi'}]}, 'descriptionModule': {'briefSummary': 'evaluate clinically and biochemically the efficacy of topically applied selenium as complementary or alternative to triamcinolone acetonide 0.1% and tacrolimus 0.1% in patients with oral lichen planus.', 'detailedDescription': 'The signs and symptoms of the oral lichen planus lesion. 2-The associated oral symptoms. 3- Glutathione biomarker level as an antioxidant enzyme in saliva by ELISA analysis .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* clinical diagnosis of OLP\n\nExclusion Criteria:\n\n1. lichenoid reaction from medication ' .\n2. any systemic autoimmune disease\n3. Pregnancy\n4. smokers"}, 'identificationModule': {'nctId': 'NCT06362005', 'acronym': 'RCT', 'briefTitle': 'The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus (Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': 'AUAREC2023011-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'group I (triamcinolone)', 'description': 'ten patients with oral lichen planus, will receive topical triamcinolone acetonide 0.1% four times per day for six weeks.', 'interventionNames': ['Drug: Triamcinolone Acetonide 0.1% Oint']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'group II (tacrollimus)', 'description': 'ten patients with oral lichen planus, will receive topical tacrolimus 0.1% four times per day for six weeks.', 'interventionNames': ['Drug: Tacrollimus Topical']}, {'type': 'EXPERIMENTAL', 'label': 'group III (selenium)', 'description': 'ten patients with oral lichen planus, will receive topical selenium four times per day for six weeks.', 'interventionNames': ['Drug: Selenium']}, {'type': 'EXPERIMENTAL', 'label': 'group IV (selenium + triamcinolone )', 'description': ': ten patients with oral lichen planus, will receive topical selenium combined with topical triamcinolone acetonide 0.1% three times per day for each for six weeks', 'interventionNames': ['Drug: Selenium & Triamcinolone Acetonide 0.1% Oint']}, {'type': 'EXPERIMENTAL', 'label': 'group V ( selenium + tacrollimus)', 'description': 'ten patients with oral lichen planus, will receive topical selenium combined with topical tacrolimus 0.1% three times per day for each for six weeks.', 'interventionNames': ['Drug: Selenium& Tacrollimus topical']}], 'interventions': [{'name': 'Triamcinolone Acetonide 0.1% Oint', 'type': 'DRUG', 'otherNames': ['Group I'], 'description': 'RCT', 'armGroupLabels': ['group I (triamcinolone)']}, {'name': 'Tacrollimus Topical', 'type': 'DRUG', 'otherNames': ['Group II'], 'description': 'RCT', 'armGroupLabels': ['group II (tacrollimus)']}, {'name': 'Selenium', 'type': 'DRUG', 'otherNames': ['Group III'], 'description': 'RCT', 'armGroupLabels': ['group III (selenium)']}, {'name': 'Selenium & Triamcinolone Acetonide 0.1% Oint', 'type': 'DRUG', 'otherNames': ['Group IV'], 'description': 'RCT', 'armGroupLabels': ['group IV (selenium + triamcinolone )']}, {'name': 'Selenium& Tacrollimus topical', 'type': 'DRUG', 'otherNames': ['Group V'], 'description': 'RCT', 'armGroupLabels': ['group V ( selenium + tacrollimus)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Alazhar university ,faculty of Dental Medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sphinx university', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturere of oral medicine ,periodontology departement', 'investigatorFullName': 'Shaymaa Hussein Rafat Kotb', 'investigatorAffiliation': 'Sphinx university'}}}}