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Tests treatment safety and results for Oral Lichen Planus
Official title Evaluation of Efficacy and Safety of add-on Tofacitinib in Patients With Oral Lichen Planus
ClinicalTrials.gov ID: NCT07131813
What this study is testing
What is Tofacitinib 5 mg BID and Triamcinolone ointment?
Tofacitinib 5 mg BID and Triamcinolone ointment is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for oral lichen planus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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)
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bhubaneswar, Odisha, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bhubaneswar, Odisha, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.