Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus

NCT07131813 · tracked via the Priya Life Science India tracker

Sponsor

All India Institute of Medical Sciences, Bhubaneswar

Phase

Phase 4

Started

2025-10-10

Last updated

2025-11-28

Condition(s) studied

Oral Lichen Planus

Investigational drug(s) / intervention(s)

Tofacitinib 5 mg BID and Triamcinolone ointmentPlacebo and Triamcinolone ointment

Tofacitinib 5 mg BID and Triamcinolone ointment: Patients in the test group will get tofacitinib 5mg capsules twice daily as an add on to triamcinolone ointment

Placebo and Triamcinolone ointment: Patients in the control group will receive identical looking capsules as placebo with triamcinolone ointment

Study summary

Many of the patients with oral lichen planus (OLP) either fail to achieve complete remission or experience frequent relapses with conventional topical corticosteroid therapy, which is currently the mainstay of treatment. Long-term corticosteroid use is limited by local and systemic adverse effects, and many patients develop steroid resistance or intolerance. To overcome these limitations, combination therapy with agents having complementary mechanisms may improve therapeutic outcomes, reduce steroid requirements, and minimize associated adverse effects. Tofacitinib, a Janus kinase (JAK1/JAK3) inhibitor, modulates the JAK-STAT signaling pathway, thereby reducing inflammatory cytokine production involved in OLP pathogenesis. Preliminary case series and pilot trials have shown promising results with tofacitinib in OLP. However, to date, no randomized controlled trial has evaluated the efficacy and safety of add-on oral tofacitinib with standard topical steroid therapy in OLP. Hence, investigators considered tofacitinib to be a candidate drug for add-on therapy due to its anti-inflammatory and immunomodulatory properties. Adding tofacitinib to ongoing topical triamcinolone therapy may increase the response rate, reduce adverse drug reactions by lowering steroid dose requirements, or achieve a quicker therapeutic effect. Therefore, the present randomized controlled trial has been planned to evaluate the efficacy and safety of oral tofacitinib as an add-on therapy in patients with OLP.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients aged ≥18 of either sex with the clinical diagnosis of oral lichen planus. * Patients with a PGA score of ≥3 (moderate and severe oral LP). * Patients who are willing to give informed written consent. Exclusion Criteria: * Treatment with a systemic corticosteroid within the last 4 weeks. * Patients on immunosuppressive agents such as azathioprine, cyclosporine, and others within one month of recruitment. * Patients with a clinical history and any lesion distribution suspicious of a lichenoid drug eruption, and patients with other skin diseases. * Past or current history of any malignancy, including moderate to severe dysplasia of the oral mucosa on oral biopsy. * Severe active infection, including active tuberculosis, hepatitis B, or C infection * Patients with cytopenia (Hb \<9g/dl, leukocyte count \<4000/mm3, platelet count \<100,000/mm3) * The patient with a history of alcohol abuse. * Decreased liver or renal function (creatinine \> 2.0mg/dl, total bilirubin \> 2.5 mg/dl). * Severe acute infection, uncontrolled diabetes mellitus, congenital or acquired immunodeficiency, severe cardiac disease (NYHA grade IV), MI in the last four weeks, severe schizophrenia, or depression. * Patient with a history of hypersensitivity to topical Triamcinolone or Tofacitinib. * Pregnancy and lactation, women of childbearing age without effective contraception.

Primary outcome measure(s)

Change in oral mucosal disease severity score from baseline — 4 weeks and12 weeks
The change in oral mucosal disease severity score (maximum 106) will be evaluated using oral mucosal disease severity score questionnaire. Each item of the questionnaire yields a score of 0 to 106. A higher score depicts severe disease.

Trial sites (1)

Facility	City	Region	Status
AIIMS, Bhubaneswar	Bhubaneswar	Odisha	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07131813 on ClinicalTrials.gov ↗ ← All trials in India