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New drug may offer safer relief for painful mouth condition

NCT ID NCT06260904

First seen Jan 11, 2026 · Last updated Jun 22, 2026 · Updated 30 times

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.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Locations

  • AIIMS Bhubaneswar

    Bhubaneswar, Odisha, 751019, India

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.

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.