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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• AIIMS, Bhubaneswar
  Bhubaneswar, Odisha, India Recruiting

Study contacts

• Study coordinator: Monalisa Jena, MD
• Email: pharm_monalisa@aiimsbhubaneswar.edu.in
• Phone: 9438884193

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.