NCT06260904

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

Completed Phase 4 Last updated 3 December 2025

What this trial tests

Phase 4 trial testing Prednisolone in Oral Lichen Planus in 64 participants. Completed in 30 October 2025.

Timeline

26 January 2024

Primary endpoint
30 October 2025

30 October 2025

Quick facts

Lead sponsor	All India Institute of Medical Sciences, Bhubaneswar
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	64
Start date	26 January 2024
Primary completion	30 October 2025
Estimated completion	30 October 2025
Sites	1 location across India

Drugs / interventions tested

• Prednisolone — full drug profile →
• Apremilast (APREMILAST) — full drug profile →
• Methotrexate — full drug profile →

Conditions studied

• Oral Lichen Planus — all drugs for Oral Lichen Planus →

Sponsor

All India Institute of Medical Sciences, Bhubaneswar

Who can join

18 and older, any sex, with Oral Lichen Planus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Exploring the Therapeutic Landscape: A Narrative Review on Topical and Oral Phosphodiesterase-4 Inhibitors in Dermatology.
   Carmona-Rocha E, Rusiñol L, Puig L. · · 2025 · cited 11× · PMID 39861739 · DOI 10.3390/pharmaceutics17010091
2. Role of PDE4 Family in Cardiomyocyte Physiology and Heart Failure.
   Sherstnev I, Judina A, Luciani GB, Ghigo A, et al · · 2025 · cited 2× · PMID 40136709 · DOI 10.3390/cells14060460