New drug may offer safer relief for painful mouth condition

NCT ID NCT06260904

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

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.

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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

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