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New combo therapy could ease painful mouth condition

NCT ID NCT07131813

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether adding the drug tofacitinib to standard steroid ointment can better control oral lichen planus, a chronic inflammatory mouth condition. About 60 adults with moderate to severe disease will receive either tofacitinib pills or placebo alongside their usual steroid treatment for 12 weeks. The goal is to see if the combination reduces disease severity and pain more effectively while potentially lowering steroid-related side effects.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

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). * Patients who are willing to give informed written consent. Exclusion Criteria: * Treatment with a systemic corticosteroid within the last 4 weeks. * Patients on immunosuppressive agents such as azathioprine, cyclosporine, and others within one month of recruitment. * Patients with a 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) * The patient with a 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, congenital or acquired immunodeficiency, severe cardiac disease (NYHA grade IV), MI in the last four weeks, severe schizophrenia, or depression. * Patient with a history of hypersensitivity to topical Triamcinolone or Tofacitinib. * Pregnancy and lactation, women of childbearing age without effective contraception.

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Conditions

The condition(s) this trial relates to.

lichen planus, oral

As listed by the trial registrant

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

Oral lichen planus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AIIMS, Bhubaneswar

    RECRUITING

    Bhubaneswar, Odisha, 751019, India

More trials for these conditions

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