Efficacy and Safety of add-on Apremilast Versus add-on Methotrexate in Patients With Oral Lichen Planus
Key facts
- Who runs it
- All India Institute of Medical Sciences, Bhubaneswar
- Where
- India1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 4
- People taking part
- 64 people enrolled
- Started
- 26 Jan 2024
- Ended
- 30 Oct 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Prednisolone
- Apremilast
- Methotrexate
- Record updated
- 3 December 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Treatment with a systemic corticosteroid within the last 4 weeks
- 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
- Patient with history of alcohol abuse
- 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
- Patients with cytopenia (Hb <9g/dl, leukocyte count <4000/mm3, platelet count <100,000/mm3)
- Decreased liver or renal function (creatinine > 2.0mg/dl, total bilirubin > 2.5 mg/dl)
- Pregnancy and lactation, women of childbearing age without effective contraception
- Patients on any immunosuppressive agents such as azathioprine, cyclosporine and others within one month of recruitment
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Lichen planus is an inflammatory disorder of unknown aetiology affecting the stratified squamous epithelia, with an estimated global prevalence of 0.22 to 0.5 %. Oral mucosa (Oral Lichen Planus; OLP) is the most commonly affected region. Corticosteroids are the primary treatment of choice. A prolonged treatment with steroids is required for clinical improvement, which increases the chances of long-term adverse effects. So, there is a need for newer, effective treatment modalities, such as retinoids, methotrexate, Janus kinase inhibitors, PDE4 inhibitors, etc.
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Of these, methotrexate is a dihydrofolate reductase inhibitor that inhibits the replication and function of T and B lymphocytes. It has shown a good response to OLP (around 83%) in a study by Lajevardi et al. and can be considered a treatment option in patients with moderate to severe OLP. Apremilast is a drug with a novel immunomodulatory mechanism of action. It inhibits phosphodiesterase type IV, which increases levels of cyclic adenosine monophosphate (cAMP), thus activating protein kinase A and inhibiting various inflammatory mediators. Based on a pilot study by Paul et al., apremilast is associated with clinical improvement in lichen planus.
Among the various treatment options, there is a lack of head-on trials. Methotrexate is an immunosuppressant with various systemic adverse effects and requires close monitoring. Whereas apremilast is a non-immunosuppressive drug with a better safety profile, it does not show such adverse effects. These drugs can be used as an add-on to low-dose steroids in view of reducing the adverse effects associated with steroid therapy. To the best of our knowledge, there is no randomized controlled trial comparing these two drugs to date. Hence, the present study has been planned to evaluate the safety and efficacy of methotrexate versus apremilast as an add-on to the standard steroid therapy in OLP patients.
The 2 groups in the trial
- Prednisolone and Methotrexate (Control Arm)Existing treatment, for comparison
prednisolone 0.75mg/kg/day (a maximum dose of 30mg at baseline) and Methotrexate 15 mg weekly for 12 weeks.
Treatment: Prednisolone and Methotrexate
- Prednisolone and Apremilast (Test Arm)Treatment being tested
prednisolone 0.75mg/kg/day (a maximum dose of 30mg at baseline) and Apremilast 30 mg twice daily for 12 weeks.
Treatment: Prednisolone and Apremilast
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Efficacy and Safety of add-on Apremilast Versus add-on Methotrexate in Patients With Oral Lichen Planus: A Randomized Controlled Trial
- Record updated
- 3 December 2025