protocolSection identificationModule nctId: NCT06327620, orgStudyIdInfo id: A002021015, briefTitle: Treatment Of Oral Lichen Planus, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-15, primaryCompletionDateStruct date: 2024-05-20, completionDateStruct date: 2024-05-20, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: This novel project aims to explore an alternative treatment for oral lichen planus (OLP), a challenging condition with limited therapeutic options. The proposed treatment involves the topical application of Daivobet ointment, a combination of calcipotriol (vitamin D analog) and betamethasone (corticosteroid), which has shown promising results in the treatment of psoriasis Vulgaris.The study will involve 15 patients aged 30-60 years with clinically confirmed intra-oral erosive lichen planus, some of whom have not responded to current therapies. Participants will apply Daivobet ointment three times daily for four weeks, with clinical assessments conducted at the beginning, and at the end of the second and fourth weeks.Inclusion criteria require the presence of bilateral oral erosive lichen planus lesions, with clinical and histopathological confirmation based on the World Health Organization's modified definition. Exclusion criteria include histological signs of dysplasia, use of drugs possibly causing lichenoid reactions, recent treatment for OLP, and hypersensitivity to the study drug.Clinical evaluations will employ a scoring system based on lesion characteristics, including ulceration, erythema, and reticulation, measured with a calibrated grid. Subjective responses will be assessed through discomfort scores on a visual analog scale, and a questionnaire will capture any adverse effects. Digital photographs will document visual changes, and incisional biopsies will be performed to confirm the diagnosis.The project aims to provide valuable insights into the efficacy and safety of the Daivobet ointment as a potential alternative treatment for oral lichen planus, offering hope for improved outcomes for patients suffering from this challenging condition., conditionsModule conditions: Lichen Planus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Daivobet ointment, topical steroids, outcomesModule primaryOutcomes measure: Clinical Improvement of Oral Lichen Planus Lesions, secondaryOutcomes measure: Objective Response Score, secondaryOutcomes measure: Subjective Response Score, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Mansoura University, Faculty of Dentistry, status: RECRUITING, city: Mansoura, state: Dakahlia, zip: 35516, country: Egypt, contacts name: Mona Montaser, role: CONTACT, email: mmontaser@mans.edu.eg, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False