Effectiveness and safety of oral prednisolone vs tofacitinib in management of oral and mucocutaneous lichen planus: Investigator blind, active-controlled, randomized clinical trial.

Lichen planus (LP) is a common mucocutaneous disease involving either the skin or mucosa or both. Intra-orally lichen planus manifests as bilateral white striations, papules, or plaques on the buccal mucosa, tongue, and gingivae. Cutaneous LP manifest as pruritic, polygonal, flat-topped, violaceous papules affecting mostly the flexural areas of the body. The oral and cutaneous LP can occur in combination. The incidence of Lichen Planus is less well-characterized anddisplays considerable geographical heterogeneity as it ranges between 14 and 250 cases/100,000 person/year. Cutaneous Lichen Planus has been reported to range between 0.2and 1.0% of the adult population. A cell-mediated immune response is mainly implicated in the pathogenesis of Lichen Planus. As OLP is considered a T cellâ€mediated disease associated with a Th1 imbalance of cytokine production, most of the therapeutic interventions have aimed to target the inflammatory pathway underlying OLP. The mainstay medications in management of OLP are antiâ€inflammatory drugs. The most commonly used antiâ€inflammatory medication is glucocorticosteroids, commonly called corticosteroids. Though the molecular pathogenesis of LP is not completely understood; however, Janus kinase signaltransducer and activator of transcription (JAK-STAT) dependent cytokines such as interferongamma (IFN-γ) are postulated to play a role in disease pathogenesis. Mucosal LP is often difficult to treat, particularly when extensive erosions are present. The JAK inhibitor tofacitinib has been used to treat 10 patients with lichen planopilaris, a scarring alopecia that has some histologic features that are similar to LP. Other authors have also previously postulated that JAK inhibition might be useful in management of Lichen Planus. Based partly on the above data and partly on the success of JAK inhibition in the treatment of other recalcitrant inflammatory skin diseases the present study will be undertaken to evaluate the effectiveness, safety and tolerability of oral prednisolone vs tofacitinib drug in management of oral lichen planus and mucocutaneous lichen planus.

The study will be an institution based, investigator blind, active controlled, randomized clinical trial. The present research study will be conducted in the College of Medicine & Sagore Dutta Hospital (CMSDH), Kolkata, West Bengal during the period of 2023-2025.

Inclusion Criteria: 1. All clinically and histologically proven cases of oral lichen planus (OLP) with or without dermatological manifestations. 2. Patients suffering from lichen planus who have not responded to topical therapy and conventional treatment. 3. Recurring cases of lichen planus 4. No use of any systemic therapy in patients suffering from lichen planus in the previous 4 weeks prior to enrolment in the study. 5. Patients willing to come for follow up at regular intervals.

Exclusion Criteria: 1. Extremes of age comprising children below the age of 18years and elderly patients above the age of 65 years will be excluded from the study. 2. Pregnant and lactating women 3. Patients with asymptomatic OLP 3. Patients with uncontrolled diabetes mellitus, hypertension 4. Patient under immunosuppressive drugs. 5. Patients with concomitant immune disorders, heart disease, renal failure, malignancy 6. Patients with neurological or psychiatric disorders. 7. Patients who have participated in any clinical trial within the last 3 months. Eligible participants after screening will be randomized into either Group A (Receiving oral prednisolone 0.5mg/kg/day) or Group B (Receiving Tofacitinib 5mg twice/day) with allocation ratio 1:1 as per the randomization sequence. Participants from both the groups will have their oral and dermal health related quality of life evaluated using a questionnaire. (OHIP-14 questionnaire and DLQI). Sample size was calculated to be 88 participants ( Group A 44 patients and Group B 44 patients ) .  Physician blinding will be achieved by having separate dispensing and assessing physician. The assessing physician will not be knowing about the medication dispensed. The assessment will be done by a single physician throughout the study. The allocation concealment will be done by Sequentially Numbered Opaque Sealed Envelope (SNOSE) technique. The patients will be given to sign informed consents before entry into the study. Their blood profile, Lipid and Urea profile, Chest x rays will be checked to match the inclusion criteria before enrollment. the patients will then be administered doses of Prednisolone (group A) and Tofacitnib(Group B) depending on the randomization sequence to be either in Group A or B. follow up visits will be conducted in 2 weeks, 6 weeks, 12 weeks and their effectiveness parameters, side effects,  severity index of the disease, quality of life would be monitored in these visits.