Adding oral tofacitinib to topical steroid ointment for moderate-to-severe oral lichen planus

Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus: A Randomized Clinical Trial

This study will test whether taking oral tofacitinib along with standard topical triamcinolone helps adults with moderate-to-severe oral lichen planus get better than steroid ointment alone.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: All India Institute of Medical Sciences, Bhubaneswar (Academic / other)
• Drugs / interventions: Tofacitinib
• Locations: 1 site (Bhubaneswar, Odisha)
• Trial ID: NCT07131813 on ClinicalTrials.gov

What this trial studies

This is a randomized, placebo-controlled, phase 4 trial comparing oral tofacitinib 5 mg twice daily plus topical triamcinolone ointment versus placebo plus topical triamcinolone in adults with moderate-to-severe oral lichen planus (PGA ≥3). Participants are recruited at a single center (AIIMS Bhubaneswar) and must meet lab and infection-screening criteria before enrollment. The trial measures clinical response and safety outcomes to see if the add-on oral JAK inhibitor reduces symptoms, relapses, or steroid requirements. Treatment duration, follow-up schedule, and specific outcome measures are determined by the protocol to capture both efficacy and adverse events.

Who should consider this trial

Good fit: Adults aged 18 or older with clinically diagnosed moderate-to-severe oral lichen planus (PGA ≥3) who can provide informed consent and meet the study's lab and infection-exclusion criteria are eligible.

Not a fit: Patients with mild OLP, active severe infections, recent systemic immunosuppression, significant liver or renal dysfunction, cytopenias, alcohol abuse, or a history of malignancy are unlikely to benefit or are excluded from participation.

Why it matters

Potential benefit: If successful, adding tofacitinib could improve symptom control and reduce relapses while lowering the need for long-term topical steroids and their side effects.

How similar studies have performed: Small case series and pilot trials have reported promising responses to tofacitinib in OLP, but randomized controlled evidence for add-on oral tofacitinib is not available until now.

Eligibility criteria

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.

Where this trial is running

Bhubaneswar, Odisha

• AIIMS, Bhubaneswar — Bhubaneswar, Odisha, India (Recruiting)

Study contacts

• Study coordinator: Monalisa Jena, MD

Conditions Oral Lichen Planus; Tofacitinib; Randomized Controlled Trial; Placebo; IL 6