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

Chulalongkorn University

Status: Not yet enrolling

Conditions: Oral Lichen Planus

Treatments: Drug: 0.1% Fluocinolone Acetonide Oral Paste; Drug: Curcumin in Nanogels

Study type: Interventional

Funder types: Other

Identifiers

NCT06932848

HREC-DCU 2025-007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Curcumin Group

Experimental group

Description:

Curcumin nanogels applied 3 times daily for 4 weeks

Treatment:

Drug: Curcumin in Nanogels

Fluocinolone Paste Group

Active Comparator group

Description:

0.1% Fluocinolone acetonide oral paste applied 3 times daily for 4 weeks

Treatment:

Drug: 0.1% Fluocinolone Acetonide Oral Paste