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

NCT ID: NCT06932848

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-06-30

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 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.

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.

Conditions

Oral Lichen Planus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Curcumin Group

Curcumin nanogels applied 3 times daily for 4 weeks

Group Type: EXPERIMENTAL

Curcumin in Nanogels

Intervention Type: DRUG

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

Fluocinolone Paste Group

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

Group Type: ACTIVE_COMPARATOR

0.1% Fluocinolone Acetonide Oral Paste

Intervention Type: 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.

Interventions

Curcumin in Nanogels

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Chulalongkorn University

Central Contacts

Tossapol Maneethorn, D.D.S.

Role: CONTACT

comeblack_ubama@hotmail.com

086-9253975

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

Role: CONTACT

pirawish@gmail.com

084-090-3309

Other Identifiers

HREC-DCU 2025-007

Identifier Type: -

Identifier Source: org_study_id