Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT06135805
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2023-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Fluocinonide 0,05% in 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-06', 'studyFirstSubmitDate': '2023-11-13', 'studyFirstSubmitQcDate': '2023-11-13', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of sings', 'timeFrame': '3 months', 'description': 'Assessment of sings using the Thongprasom scoring system at baseline and after 2 months'}], 'secondaryOutcomes': [{'measure': 'Assessment of symptoms', 'timeFrame': '3 months', 'description': 'Assessment of symptoms using the VAS scale at baseline and after 2 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral Lichen Planus']}, 'descriptionModule': {'briefSummary': 'A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of Fluocinonide 0,05% and determinate the statistical significance of the outcome variables. Oral cavity lichen is a chronic inflammatory condition affecting the mucosa of the oral cavity , which significantly reduces the quality of life of affected individuals.', 'detailedDescription': 'A double-blind placebo-controlled study was conducted to evaluate the clinical efficacy of Fluocinonide 0.05% oral gel and determine the statistical significance of outcome variables.\n\n20 patients with Oral Lichen Planus were divided by a randomization system, into two groups: case group treated with Fluocinonide 0.05% oral gel and applied to oral lesions 2 times a day for 1 month and a placebo group as a control group; with 2 months of follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical and histologic diagnosis of Lichen Planus Orale;\n* Presence of symptoms related to Lichen Planus Orale;\n* Clinical follow-up period of at least 12 weeks;\n* Acceptance of informed consent\n\nExclusion Criteria:\n\n* State of pregnancy or lactation; h\n* Histologic signs of dysplasia;\n* Medications that induce a lichenoid response (ACE inhibitors, β-blockers, etc.);\n* Presence of amalgam fillings in the vicinity of lesions;\n* Treatment of oral lichen in the previous 6 months from the start of the program;\n* Presence of extraoral lesions (genital, skin, etc.);\n* Diabetes being treated with oral hypoglycemic drugs;\n* History of previous immunodeficiency;\n* HIV seropositivity;\n* Previous allogeneic bone marrow transplantation;\n* Diagnosis of LES or other autoimmune disease'}, 'identificationModule': {'nctId': 'NCT06135805', 'briefTitle': 'Impact of Fluocinonide 0,05% in Oral Lichen Planus', 'organization': {'class': 'OTHER', 'fullName': 'University of Catania'}, 'officialTitle': 'Impact of the Efficacy of Fluocinonide 0.05% Oral Gel in the Treatment of Oral Lichen Planus', 'orgStudyIdInfo': {'id': '121-30'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Comparator: Fluocinonide 0,,05% oral gel', 'description': 'Patients were treated with a topical gel of Fluocinonide 0.05%, applied to oral lesions twice daily for 1 month.', 'interventionNames': ['Drug: Fluocinonide 0,05% oral gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator: Placebo', 'description': 'Patients were treated with a topical gel of placebo, applied to oral lesions twice daily for 1 month.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Fluocinonide 0,05% oral gel', 'type': 'DRUG', 'description': 'Application of Fluocinonide oral gel on oral syntomatic lesions', 'armGroupLabels': ['Active Comparator: Fluocinonide 0,,05% oral gel']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Application of placebo oral gel on oral lesions', 'armGroupLabels': ['Placebo Comparator: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95124', 'city': 'Catania', 'country': 'Italy', 'facility': 'AOU Policlinico G. Rodolico', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}], 'overallOfficials': [{'name': 'Gaetano Isola', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Catania'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '3 months', 'ipdSharing': 'YES', 'accessCriteria': 'Pubmed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Catania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Gaetano Isola', 'investigatorAffiliation': 'University of Catania'}}}}