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

NCT07131813 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-11-28

No results posted yet for this 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.

Conditions

  • Oral Lichen Planus

Interventions

DRUG

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

DRUG

Placebo and Triamcinolone ointment

Patients in the control group will receive identical looking capsules as placebo with triamcinolone ointment

Sponsors & Collaborators

  • All India Institute of Medical Sciences, Bhubaneswar

    lead OTHER

Principal Investigators

  • Rituparna Maiti, MD · Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-10
Primary Completion
2027-01-01
Completion
2027-06-01

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07131813 on ClinicalTrials.gov