Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06932848

The Therapeutic Effect of Curcumin in Nanogels Compared to 0.1% FAO in the Management of 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Chulalongkorn University

Bangkok, 10400, Thailand

Location status: Recruiting

Location contact

Tossapol Maneethorn, D.D.S.

CONTACT

[email protected]

+66 86 925 3975

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Curcumin in Nanogels

Drug

Participants will apply curcumin nanogels to affected oral areas three times daily for 4 weeks.

0.1% Fluocinolone Acetonide Oral Paste

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Pirawish Limlawan, D.D.S., Ph.D.

CONTACT

[email protected]

084-090-3309

Tossapol Maneethorn, D.D.S.

CONTACT

[email protected]

086-9253975

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2025
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.