Actively Recruiting
Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus
Led by All India Institute of Medical Sciences, Bhubaneswar · Updated on 2025-11-28
60
Participants Needed
1
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older of any gender with a clinical diagnosis of oral lichen planus
- Patients with a Physician Global Assessment (PGA) score of 3 or higher indicating moderate to severe oral lichen planus
- Patients willing to provide informed written consent
You will not qualify if you...
- Use of systemic corticosteroids within the last 4 weeks
- Use of immunosuppressive agents such as azathioprine or cyclosporine within 1 month before recruitment
- Clinical history or lesions suggesting lichenoid drug eruption or other skin diseases
- Past or current malignancy, including moderate to severe oral mucosal dysplasia
- Severe active infections including tuberculosis, hepatitis B or C
- Cytopenia defined as hemoglobin less than 9 g/dl, leukocyte count less than 4000/mm3, or platelet count less than 100,000/mm3
- History of alcohol abuse
- Impaired liver function (creatinine over 2.0 mg/dl) or renal function (total bilirubin over 2.5 mg/dl)
- Severe acute infection, uncontrolled diabetes, immunodeficiency, severe heart disease (NYHA grade IV), recent myocardial infarction within 4 weeks, severe schizophrenia or depression
- Known allergy to topical triamcinolone or tofacitinib
- Pregnancy, breastfeeding, or women of childbearing age without effective contraception
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
AIIMS, Bhubaneswar
Bhubaneswar, Odisha, India, 751019
Actively Recruiting
Research Team
M
Monalisa Jena, MD
CONTACT
B
Biswanath Behera, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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