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NCT Number: NCT06260904

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

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.

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.

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Key information

Conditions

Oral Lichen Planus Lichen Planus Lichen Planus, Oral Lichenoid Eruptions Mouth Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AIIMS Bhubaneswar

Bhubaneswar, Odisha, 751019, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prednisolone

Drug

prednisolone 0.75mg/kg/day (a maximum dose of 30mg at baseline) orally

Apremilast

Drug

Apremilast 30 mg twice daily orally

methotrexate

Drug

Methotrexate 15 mg weekly orally

Primary outcomes

  1. Pain by Visual Analogue Scale (VAS) score

    Time frame: 8 weeks and 12 weeks

    Change in Visual Analogue Scale (VAS) score after treatment with prednisolone and methotraxate Vs Prednisolone and Apremilast at baseline, 8 weeks and 12 weeks. The VAS consists of a 10 cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be') interpretation of the scores: 0 =No Pain 2 = Mild 4 = Nagging 6 =Miserable 8 =Intense 10 = Worst

Secondary outcomes

  1. Severity by Physician global assessment of disease (PGA) score

    Time frame: 8 weeks and 12 weeks

    compare the proportion of patients achieving a reduction of Physician global assessment of disease (PGA) score of 0 or a 2-grade reduction (minimum initial PGA 3) after treatment with prednisolone and methotraxate Vs Prednisolone and Apremilast at baseline, 8 weeks and 12 weeks by using a 6-point disease severity scoring system.

    (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe).

  2. Severity and pain by oral mucosal disease severity score

    Time frame: 8 weeks and 12 weeks

    the change in oral mucosal disease severity score (maximum 106) after treatment with prednisolone and methotraxate Vs Prednisolone and Apremilast at baseline, 8 weeks and 12 weeks.

    Total score = Site score + Activity score + pain Score (Maximum 106) higher scores indicating greater disease activity

  3. serum IL 6 level

    Time frame: 12 weeks

    Change in serum IL 6 after treatment with prednisolone and methotraxate Vs Prednisolone and Apremilast he levels of salivary and serum IL-6 were significantly higher among patients with OLP than among healthy control participants

  4. Quality of life by using oral health-related quality of life score (ORAL HEALTH IMPACT PROFILE - 14 )

    Time frame: 8 weeks and 12 weeks

    Change in the oral health-related quality of life from baseline after 8 and 12 weeks.

    designed to assess patients' perception of the impact of oral disorders on their quality of life (QoL).

    The OHIP-14 scores can range from 0 to 56 and are calculated by summing the ordinal values for the 14 items. The domain scores can range from 0 to 8. Higher OHIP-14 scores indicate worse and lower scores indicate better OHRQol

  5. Incidence of treatment-emergent adverse events of both test and control group

    Time frame: 12 weeks

    treatment-emergent adverse events in both the groups The adverse events in the patients are to be assessed by non-directive questioning at the time of the follow-up visit. Patients can access the investigators directly in case of any adverse events and report them. All adverse events irrespective of their previous reported status are to be recorded with details about nature, intensity, duration, measures taken, outcome, and causal relationship to prednisolone, methotrexate and apremilast.

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences, Bhubaneswar

Other

Registry information

Official study title

Efficacy and Safety of add-on Apremilast Versus add-on Methotrexate in Patients With Oral Lichen Planus: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 15, 2024
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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