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

March 4, 2026 updated by: Chulalongkorn University

The Therapeutic Effect of Curcumin in Nanogels Compared to 0.1% Fluocinolone Acetonide Oral Paste in the Management of Atrophic-Erosive Oral Lichen Planus

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 lichen planus (OLP). The study aims to determine whether curcumin nanogels, a natural treatment with enhanced bioavailability, are as effective and better tolerated than standard corticosteroid therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 are the standard treatment, their long-term use is associated with adverse effects. Curcumin, a natural compound with anti-inflammatory and antioxidant properties, has shown promise as an alternative treatment. However, its clinical application is limited by poor bioavailability.

This randomized, double-blind, controlled clinical trial aims to compare the therapeutic effects of curcumin in nanogels and 0.1% fluocinolone acetonide oral paste in patients with atrophic-erosive OLP. Thirty eligible participants will be randomly assigned to either the curcumin nanogel or fluocinolone group, and treatment outcomes will be evaluated using the Oral Lichen Planus Disease Activity Scale (OLP-DAS) and a patient satisfaction questionnaire over a 4-week period.

The study is conducted at the Faculty of Dentistry, Chulalongkorn University, and seeks to evaluate whether curcumin nanogels offer comparable therapeutic efficacy to corticosteroids, with potentially fewer side effects.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Pirawish Limlawan, D.D.S., Ph.D.
  • Phone Number: 084-090-3309
  • Email: pirawish@gmail.com

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Recruiting
        • Faculty of Dentistry, Chulalongkorn University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Curcumin Group
Curcumin nanogels applied 3 times daily for 4 weeks
Drug: Curcumin in Nanogels
Participants will apply curcumin nanogels to affected oral areas three times daily for 4 weeks.
Active Comparator: Fluocinolone Paste Group
0.1% Fluocinolone acetonide oral paste applied 3 times daily for 4 weeks
Drug: 0.1% Fluocinolone Acetonide Oral Paste
Participants will apply 0.1% fluocinolone acetonide oral paste to the affected oral mucosa three times daily for 4 weeks. This corticosteroid paste is the standard treatment for oral lichen planus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in OLP-DAS Score
Time Frame: Baseline, 2 weeks, and 4 weeks

Evaluation of change in Oral Lichen Planus-Disease Activity Scale (OLP-DAS) score, which includes lesion severity, lesion extent, and pain score, from baseline to follow-up

The Oral Lichen Planus-Disease Activity Scale (OLP-DAS) includes 3 components:

  • OLP Sign Score (0-65)
  • OLP Severity Index (0-20)
  • Numerical Rating Scale for pain (0-10)

The total OLP-DAS score ranges from 0 to 95. Higher scores indicate worse disease activity.
Baseline, 2 weeks, and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Product Satisfaction Questionnaire
Time Frame: At 4 weeks after treatment start

Product satisfaction will be evaluated using a modified 6-item Product Satisfaction Questionnaire. Items include:

  • Taste of the oral paste
  • Oral sensation
  • Irritation
  • Convenience of use
  • Willingness to continue using the product
  • Overall satisfaction

Each item is scored from 0 (not satisfied at all) to 10 (completely satisfied). The total score ranges from 0 to 60. Higher scores indicate better satisfaction.

Minimum Value: 0 Maximum Value: 60 Units of Measure: Points Meaning of Higher Scores: Better outcome (higher satisfaction)
At 4 weeks after treatment start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Pirawish Limlawan, D.D.S., Ph.D., Faculty of Dentistry, Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

April 10, 2025

First Submitted That Met QC Criteria

April 10, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREC-DCU 2025-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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