Efficacy and Safety of add-on Apremilast Versus add-on Methotrexate in Patients With Oral Lichen Planus

Launched by ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR · Feb 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of two medications, apremilast and methotrexate, as additional treatments for patients with oral lichen planus (OLP). OLP is a condition that causes painful sores in the mouth and is often treated with corticosteroids. However, long-term use of steroids can lead to unwanted side effects, so researchers are exploring whether apremilast, which has a different way of reducing inflammation, might be a better option compared to methotrexate, a more traditional treatment that requires careful monitoring.

To participate in the trial, individuals must be at least 18 years old and diagnosed with moderate to severe oral lichen planus that hasn’t improved with other steroid treatments. Certain conditions, such as recent use of other immunosuppressive drugs or serious health issues, may prevent someone from joining. Participants will receive either apremilast or methotrexate alongside low-dose steroids, and the researchers will closely monitor their health and any side effects. This study aims to provide valuable information on which treatment is more effective and safer for managing oral lichen planus.

Gender

ALL

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.