What is tofacitinib studying for oral lichen planus?

Tofacitinib is being studied to see if it can improve treatment when added to standard steroid ointment for oral lichen planus, a condition causing painful mouth lesions. This trial aims to find out if the combination offers better control of symptoms and fewer side effects. The study is led by the All India Institute of Medical Sciences, Bhubaneswar.

Who may be eligible for this oral lichen planus clinical trial?

Adults aged 18 years or older with a diagnosis of moderate to severe oral lichen planus may be eligible. The study includes all genders but excludes those recently treated with systemic steroids or immunosuppressants, pregnant or breastfeeding women without contraception, and people with certain infections or organ problems. Please review eligibility criteria for more details.

Is there any cost to participate in this oral lichen planus clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan for their own travel costs.

Actively Recruiting

Phase 4

Age: 18Years +

All Genders

ID07131813

Study of Oral Tofacitinib Added to Topical Triamcinolone for Treating Oral Lichen Planus

Led by All India Institute of Medical Sciences, Bhubaneswar · Updated on 2025-11-28

Participants Needed

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating oral lichen planus OLP, a chronic inflammatory condition affecting the mouth that can cause discomfort and impair basic functions like eating and speaking. This study aims to evaluate the effectiveness and safety of adding oral tofacitinib, a drug that targets inflammatory pathways, to standard topical corticosteroid treatment. The goal is to improve treatment outcomes, reduce steroid side effects, and provide better symptom relief for patients who often experience relapses or incomplete remission with steroids alone. Participants will be randomly assigned to receive either tofacitinib capsules twice daily alongside topical triamcinolone ointment or placebo capsules with the same ointment. The study involves a double-blind design where neither participants nor researchers know which treatment is given. This approach compares the combined therapy against standard steroid treatment over a 12-week period to assess benefits and risks. Throughout the trial, participants will have their oral disease severity, pain levels, physician-assessed disease status, and quality of life regularly evaluated at baseline, 4 weeks, and 12 weeks. Blood tests will measure inflammatory markers and monitor safety. Researchers will track any side effects and treatment responses to understand how adding tofacitinib affects disease management. The entire study runs from October 2025 through June 2027, with careful follow-up to ensure participants well-being.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patients aged 6518 of either sex with the clinical diagnosis of oral lichen planus.
Patients with a PGA score of 653 (moderate and severe oral LP).
Patients who are willing to give informed written consent.

You will not qualify if you...

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.

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants receive either tofacitinib capsules twice daily or placebo capsules, both in addition to topical triamcinolone ointment to manage oral lichen planus symptoms.

Visits at baseline, Week 4, and Week 12