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Taking peoplePhase 4

Tofacitinib added to steroid ointment for oral lichen planus

Tests tofacitinib tablets alongside triamcinolone ointment in adults with oral lichen planus.

Key facts

Who runs it
All India Institute of Medical Sciences, Bhubaneswar
Where
India1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus
Status
Recruiting
Phase
Phase 4
People taking part
60 people, planned
Started
10 Oct 2025
Expected to end
1 Jun 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Tofacitinib 5 mg BID and Triamcinolone ointment
  • Placebo and Triamcinolone ointment
Record updated
28 November 2025

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Treatment with a systemic corticosteroid within the last 4 weeks
  • 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
  • The patient with a history of alcohol abuse
  • 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
  • Patients with cytopenia (Hb <9g/dl, leukocyte count <4000/mm3, platelet count <100,000/mm3)
  • Decreased liver or renal function (creatinine > 2.0mg/dl, total bilirubin > 2.5 mg/dl)
  • Pregnancy and lactation, women of childbearing age without effective contraception
  • Patients on immunosuppressive agents such as azathioprine, cyclosporine, and others within one month of recruitment

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Test: Capsule Tofacitinib + Triamcinolone ointmentTreatment being tested

    Patients in the test group will get Tofacitinib 5mg twice daily as an add on to topical triamcinolone ointment

    Treatment: Tofacitinib 5 mg BID and Triamcinolone ointment

  • Control: Placebo capsules + Triamcinolone ointmentExisting treatment, for comparison

    Patients in the control group will get similar looking capsules containing placebo in addition to triamcinolone ointment

    Treatment: Placebo and Triamcinolone ointment

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus: A Randomized Clinical Trial
Plain-language title
Tofacitinib added to steroid ointment for oral lichen planusGenerated from the registry record. The registry title is the official one.
Record updated
28 November 2025
Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus (NCT07131813) – Frontlight Research