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

RecruitingPhase 4Ages 18 Years - anyAllAll India Institute of Medical Sciences, Bhubanesโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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 effic

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patients aged โ‰ฅ18 of either sex with the clinical diagnosis of oral lichen planus. * Patients with a PGA score of โ‰ฅ3 (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.
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What it tests

  • Tofacitinib 5 mg BID and Triamcinolone ointment
  • Placebo and Triamcinolone ointment
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Where

1 site
AIIMS, Bhubaneswar
Bhubaneswar, India
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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