Oral lichen planus: comparative efficacy and treatment costs-a systematic review.
Shaiba Sandhu, Brittany A Klein, Malak Al-Hadlaq...
https://pubmed.ncbi.nlm.nih.gov/35524296Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID07131813
Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus: A Randomized Clinical Trial
Led by All India Institute of Medical Sciences, Bhubaneswar · Updated on 2025-11-28
60
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
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.
AI-Screening
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1
2
3
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
Trial Site Locations
Total: 1 location
1
AIIMS, Bhubaneswar
Bhubaneswar, Odisha, India, 751019
Actively Recruiting
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Research Team
M
Monalisa Jena, MD
B
Biswanath Behera, MD
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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Published Research Related To This Trial
Metabolic adverse events associated with systemic corticosteroid therapy-a systematic review and meta-analysis.
Spoorthy Kulkarni, Hannah Durham, Luke Glover...
https://pubmed.ncbi.nlm.nih.gov/36549729Treatment trends in oral lichen planus and oral lichenoid lesions (Review).
Doina Rotaru, Radu Chisnoiu, Alina Monica Picos...
https://pubmed.ncbi.nlm.nih.gov/33123228CD8+ tissue-resident memory T cells induce oral lichen planus erosion via cytokine network.
Maofeng Qing, Dan Yang, Qianhui Shang...
https://pubmed.ncbi.nlm.nih.gov/37555396Oral lichen planus: a literature review and update.
Mohammad S Alrashdan, Nicola Cirillo, Michael McCullough
https://pubmed.ncbi.nlm.nih.gov/27349424Lichen planus.
R Katta
https://pubmed.ncbi.nlm.nih.gov/10865927