protocolSection identificationModule nctId: NCT06260904, orgStudyIdInfo id: AIIMS BBSR/PGThesis/23-24/112, briefTitle: Efficacy and Safety of add-on Apremilast Versus add-on Methotrexate in Patients With Oral Lichen Planus, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: All India Institute of Medical Sciences, Bhubaneswar, class: OTHER, descriptionModule briefSummary: Lichen planus is an inflammatory disorder of unknown aetiology affecting the stratified squamous epithelia, with an estimated global prevalence of 0.22 to 0.5 %. Oral mucosa (Oral Lichen Planus; OLP) is the most commonly affected region. Corticosteroids are the primary treatment of choice. A prolonged treatment with steroids is required for clinical improvement, which increases the chances of long-term adverse effects. So, there is a need for newer, effective treatment modalities, such as retinoids, methotrexate, Janus kinase inhibitors, PDE4 inhibitors, etc.Of these, methotrexate is a dihydrofolate reductase inhibitor that inhibits the replication and function of T and B lymphocytes. It has shown a good response to OLP (around 83%) in a study by Lajevardi et al. and can be considered a treatment option in patients with moderate to severe OLP. Apremilast is a drug with a novel immunomodulatory mechanism of action. It inhibits phosphodiesterase type IV, which increases levels of cyclic adenosine monophosphate (cAMP), thus activating protein kinase A and inhibiting various inflammatory mediators. Based on a pilot study by Paul et al., apremilast is associated with clinical improvement in lichen planus.Among the various treatment options, there is a lack of head-on trials. Methotrexate is an immunosuppressant with various systemic adverse effects and requires close monitoring. Whereas apremilast is a non-immunosuppressive drug with a better safety profile, it does not show such adverse effects. These drugs can be used as an add-on to low-dose steroids in view of reducing the adverse effects associated with steroid therapy. To the best of our knowledge, there is no randomized controlled trial comparing these two drugs to date. Hence, the present study has been planned to evaluate the safety and efficacy of methotrexate versus apremilast as an add-on to the standard steroid therapy in OLP patients., conditionsModule conditions: Oral Lichen Planus, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized, add-on, active-controlled, open-label, parallel-design clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Prednisolone, interventions name: Apremilast, interventions name: Methotrexate, outcomesModule primaryOutcomes measure: Pain by Visual Analogue Scale (VAS) score, secondaryOutcomes measure: Severity by Physician global assessment of disease (PGA) score, secondaryOutcomes measure: Severity and pain by oral mucosal disease severity score, secondaryOutcomes measure: serum IL 6 level, secondaryOutcomes measure: Quality of life by using oral health-related quality of life score (ORAL HEALTH IMPACT PROFILE - 14 ), secondaryOutcomes measure: Incidence of treatment-emergent adverse events of both test and control group, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AIIMS Bhubaneswar, city: Bhubaneswar, state: Odisha, zip: 751019, country: India, contacts name: Monalisa Jena, MD, role: CONTACT, phone: 09438884193, email: pharm_monalisa@aiimsbhubaneswar.edu.in, contacts name: Biswanath Behera, MD, role: CONTACT, phone: 07978351200, email: dermat_biswanath@aiimsbhubaneswar.edu.id, contacts name: Biswanath Behera, role: SUB_INVESTIGATOR, contacts name: Madhusmita Sethy, role: PRINCIPAL_INVESTIGATOR, contacts name: Mowdharani PS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.27241, lon: 85.83385, hasResults: False