Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT06260904
Eligibility Criteria:
Inclusion 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).
* Patient not responding to topical or intralesional corticosteroid.
* Patients who are willing to give informed written consent.
Exclusion Criteria:
* Treatment with a systemic corticosteroid within the last 4 weeks.
* Patients on any immunosuppressive agents such as azathioprine, cyclosporine and others within one month of recruitment.
* Patients with 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)
* Patient with 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, untreated glaucoma, congenital or acquired immunodeficiency, active gastroduodenal ulcer, severe osteoporosis, severe cardiac disease (NYHA grade IV), MI in the last four weeks, severe schizophrenia or depression.
* Patient with a history of hypersensitivity to Methotrexate or Apremilast.
* Pregnancy and lactation, women of childbearing age without effective contraception.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06260904
Study Brief:
Protocol Section:
NCT06260904