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Study identifier: NCT07131813 Synced from ClinicalTrials.gov · July 28, 2026
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Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus

Condition: Oral Lichen Planus  ·  Sponsor: All India Institute of Medical Sciences, Bhubaneswar

PhasePhase 4
Planned participants60
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 …

This description comes directly from the study's public registry record.

Talk to the study team

Monalisa Jena, MD  ·  9438884193  ·  pharm_monalisa@aiimsbhubaneswar.edu.in

Biswanath Behera, MD  ·  7978351200  ·  Dermat_biswanath@aiimsbhubaneswar.edu.in

Always discuss trial participation with your own doctor first.

Locations (1)

AIIMS, BhubaneswarBhubaneswar, Odisha, IndiaRecruiting

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Source record: clinicaltrials.gov/study/NCT07131813