Status:

NOT_YET_RECRUITING

The Therapeutic Effect of Curcumin in Nanogels Compared to 0.1% FAO in the Management of Oral Lichen Planus

Lead Sponsor:

Chulalongkorn University

Conditions:

Oral Lichen Planus

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This randomized, double-blind clinical trial evaluates the therapeutic effects of curcumin in nanogels compared to 0.1% fluocinolone acetonide oral paste in the management of atrophic-erosive oral lic...

Detailed Description

Oral lichen planus (OLP) is a chronic, immune-mediated inflammatory condition that causes painful mucosal lesions and significantly impairs patients' quality of life. Although topical corticosteroids ...

Eligibility Criteria

Inclusion

  • Age 18 years or older
  • Ability to provide written informed consent
  • Clinically and histopathologically confirmed diagnosis of erosive or atrophic oral lichen planus (OLP)
  • Presence of symptoms (NRS pain score \> 0 at baseline)
  • Ability to communicate and follow instructions
  • Willingness to apply oral paste treatment and comply with study protocol

Exclusion

  • Pregnancy or lactation
  • Current orthodontic treatment
  • Uncontrolled diabetes mellitus (HbA1c \> 7% or FPG \> 130 mg/dL)
  • Use of anticoagulants or antiplatelet agents
  • Severe dry mouth (Challacombe score \> 7)
  • History of gastric ulcers, duodenal ulcers, or gallstones
  • Presence of any active malignancy or infection
  • Use of topical/systemic treatment for OLP in the past 2 weeks
  • Current use of immunosuppressants
  • Known allergy to corticosteroids or herbal agents such as turmeric
  • Diagnosis of oral lichenoid contact lesion or graft-versus-host disease (GVHD)
  • History of allogeneic bone marrow transplantation
  • Current smokers

Key Trial Info

Start Date :

June 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2026

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06932848

Start Date

June 1 2025

End Date

June 30 2026

Last Update

April 22 2025

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