NCT07131813

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

Recruiting now Phase 4 Last updated 28 November 2025

What this trial tests

Phase 4 trial testing Tofacitinib 5 mg BID and Triamcinolone ointment in Oral Lichen Planus in 60 participants. Currently enrolling.

Timeline

10 October 2025

Primary endpoint
1 January 2027

1 June 2027

Quick facts

Lead sponsor	All India Institute of Medical Sciences, Bhubaneswar
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	10 October 2025
Primary completion	1 January 2027
Estimated completion	1 June 2027
Sites	1 location across India

Drugs / interventions tested

• Tofacitinib 5 mg BID and Triamcinolone ointment — full drug profile →
• Placebo and Triamcinolone ointment — full drug profile →

Conditions studied

• Oral Lichen Planus — all drugs for Oral Lichen Planus →

Sponsor

All India Institute of Medical Sciences, Bhubaneswar

Who can join

18 and older, any sex, with Oral Lichen Planus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Oxidative stress and metabolic dysfunction in oral lichen planus pathogenesis.
   Song HJ, Kang KH, Byun JS, Kim DY. · · 2026 · PMID 41937864 · DOI 10.1080/19768354.2026.2648907