Curcumin nanogel versus 0.1% fluocinolone acetonide oral paste for atrophic-erosive oral lichen planus
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
Run by Chulalongkorn University · NCT06932848 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Chulalongkorn University Academic / other |
| Locations | 1 site (Bangkok) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | June 30, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | March 6, 2026 |
| Trial ID | NCT06932848 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.