The Therapeutic Effect of Curcumin in Nanogels Compared to 0.1% FAO in the Management of Oral Lichen Planus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Curcumin in Nanogels, 0.1% Fluocinolone Acetonide Oral Paste.
- Who it may be relevant to
- Registry conditions: Oral Lichen Planus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Drug Curcumin in Nanogels
Participants will apply curcumin nanogels to affected oral areas three 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.
Primary outcome measures
- Change in OLP-DAS Score [Time frame: Baseline, 2 weeks, and 4 weeks]
Secondary outcome measures (1)
- Product Satisfaction Questionnaire [Time frame: At 4 weeks after treatment start]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Thailand · 1 center
- Faculty of Dentistry, Chulalongkorn University — Bangkok
Identifiers
NCT: NCT06932848 · HREC-DCU 2025-007