Curcumin nanogel versus 0.1% fluocinolone acetonide oral paste for atrophic-erosive oral lichen planus
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 will test whether curcumin delivered in a nanogel works as well as 0.1% fluocinolone acetonide oral paste for adults with atrophic-erosive oral lichen planus.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chulalongkorn University Academic / other |
| Locations | 1 site (Bangkok) |
| Trial ID | NCT06932848 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, controlled comparison of curcumin formulated in nanogels versus standard 0.1% fluocinolone acetonide oral paste in patients with atrophic-erosive oral lichen planus. Thirty eligible participants will be randomly assigned to one of the two topical treatment arms and treated for four weeks. Outcomes include changes in the Oral Lichen Planus Disease Activity Scale (OLP-DAS) and patient satisfaction measures, with monitoring for side effects. The trial is conducted at the Faculty of Dentistry, Chulalongkorn University, and aims to determine whether improved curcumin delivery offers similar efficacy with better tolerability than corticosteroids.
Who should consider this trial
Good fit: Adults (18+) with clinically and histopathologically confirmed atrophic-erosive or erosive oral lichen planus who have baseline symptoms and can apply an oral paste and attend follow-up visits are eligible.
Not a fit: Patients who are pregnant or breastfeeding, immunosuppressed, have uncontrolled diabetes, severe dry mouth, active malignancy or infection, recent topical/systemic OLP treatment, allergy to turmeric or corticosteroids, or who cannot attend the Bangkok site are unlikely to benefit from or be eligible for this trial.
Why it matters
Potential benefit: If successful, curcumin nanogel could provide an effective non-steroidal topical option with fewer corticosteroid-related side effects for patients with OLP.
How similar studies have performed: Small trials and case series have suggested curcumin can reduce OLP symptoms, but nanogel delivery to improve bioavailability is relatively novel and not yet proven in larger randomized comparisons.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bangkok
- Faculty of Dentistry, Chulalongkorn University — Bangkok, Thailand (Recruiting)
Study contacts
- Principal investigator: Pirawish Limlawan, D.D.S., Ph.D. — Faculty of Dentistry, Chulalongkorn University
- Study coordinator: Tossapol Maneethorn, D.D.S.
- Email: comeblack_ubama@hotmail.com
- Phone: 086-9253975
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.