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New drug may offer safer relief for painful mouth condition

NCT ID NCT06260904

Disease control Sponsor: All India Institute of Medical Sciences, Bhubaneswar Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two drugs, apremilast and methotrexate, added to standard steroid treatment for oral lichen planus, a chronic inflammatory mouth condition causing pain and sores. 64 adults with moderate to severe disease who didn't respond to topical steroids took either apremilast or methotrexate alongside prednisolone for 12 weeks. The goal was to see which combination better reduces pain and disease severity while limiting steroid side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Apremilast and methotrexate
What this could lead to
If apremilast works as well as methotrexate but with fewer side effects, it could become a safer add-on treatment for oral lichen planus.
What could go wrong
This is a small, completed Phase 4 trial with only 64 participants. Results may not apply to everyone, and both drugs can cause side effects like nausea or liver issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

64 people

The number who actually took part.

Started

Jan 2024

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

lichen planus lichen planus, oral

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Oral lichen planus

Contacts and locations

Locations

  • AIIMS Bhubaneswar

    Bhubaneswar, Odisha, 751019, India

More trials for these conditions

Other studies related to the condition(s) this trial covers.