Oral Lichen PlanusNCT06932848
The Therapeutic Effect of Curcumin in Nanogels Compared to 0.1% FAO in the Management of Oral Lichen Planus
A study testing Curcumin in Nanogels and 0.1% Fluocinolone Acetonide Oral Paste in people with Oral Lichen Planus, run by Chulalongkorn University at 1 site in Thailand.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Curcumin in Nanogels and 0.1% Fluocinolone Acetonide Oral Paste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Chulalongkorn University
Bangkok, 10400
Tossapol Maneethorn, D.D.S., +66 86 925 3975, comeblack_ubama@hotmail.com
About this study
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
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.
Read the 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
- Being tested
- Curcumin in Nanogels, 0.1% Fluocinolone Acetonide Oral Paste
- Keywords
- Atrophic-Erosive Oral Lichen Planus, Curcumin, Nanogels, Fluocinolone Acetonide, Mucosal Disease, Autoimmune Disease
- Medical subject headings
- Lichen Planus, Oral, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin in NanogelsDrug
Participants will apply curcumin nanogels to affected oral areas three times daily for 4 weeks.
0.1% Fluocinolone Acetonide Oral PasteDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Curcumin Group | Experimental | Curcumin nanogels applied 3 times daily for 4 weeks Receives: Drug: Curcumin in Nanogels |
| Fluocinolone Paste Group | Active comparator | 0.1% Fluocinolone acetonide oral paste applied 3 times daily for 4 weeks Receives: Drug: 0.1% Fluocinolone Acetonide Oral Paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in OLP-DAS Score
Evaluation of change in Oral Lichen Planus-Disease Activity Scale (OLP-DAS) score, which includes lesion severity, lesion extent, and pain score, from baseline to follow-up
The Oral Lichen Planus-Disease Activity Scale (OLP-DAS) includes 3 components:
- OLP Sign Score (0-65)
- OLP Severity Index (0-20)
- Numerical Rating Scale for pain (0-10)
The total OLP-DAS score ranges from 0 to 95. Higher scores indicate worse disease activity.
Measured: Baseline, 2 weeks, and 4 weeks
Secondary outcomes (1)
Product Satisfaction Questionnaire
Product satisfaction will be evaluated using a modified 6-item Product Satisfaction Questionnaire. Items include:
- Taste of the oral paste
- Oral sensation
- Irritation
- Convenience of use
- Willingness to continue using the product
- Overall satisfaction
Each item is scored from 0 (not satisfied at all) to 10 (completely satisfied). The total score ranges from 0 to 60. Higher scores indicate better satisfaction.
Minimum Value: 0 Maximum Value: 60 Units of Measure: Points Meaning of Higher Scores: Better outcome (higher satisfaction)
Measured: At 4 weeks after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start1 Jun 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pirawish Limlawan, D.D.S., Ph.D., Principal investigator, Faculty of Dentistry, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932848
- Sponsor's protocol ID
- HREC-DCU 2025-007
- Status last verified
- Mar 2026
- First submitted
- 10 Apr 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06932848
- Acronym / sponsor ID
- HREC-DCU 2025-007
- Conditions
- Oral Lichen Planus
- Keywords
- Atrophic-Erosive Oral Lichen Planus, Curcumin, Nanogels, Fluocinolone Acetonide, Mucosal Disease, Autoimmune Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curcumin Group | Experimental | Drug: Curcumin in NanogelsCurcumin nanogels applied 3 times daily for 4 weeks |
| Fluocinolone Paste Group | Active comparator | Drug: 0.1% Fluocinolone Acetonide Oral Paste0.1% Fluocinolone acetonide oral paste applied 3 times daily for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcumin in NanogelsParticipants will apply curcumin nanogels to affected oral areas three times daily for 4 weeks. | Drug | Curcumin Group |
| 0.1% Fluocinolone Acetonide Oral PasteParticipants 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. | Drug | Fluocinolone Paste Group |
Primary outcome
Change in OLP-DAS Score
Time frame: Baseline, 2 weeks, and 4 weeks
Evaluation of change in Oral Lichen Planus-Disease Activity Scale (OLP-DAS) score, which includes lesion severity, lesion extent, and pain score, from baseline to follow-up The Oral Lichen Planus-Disease Activity Scale (OLP-DAS) includes 3 components: * OLP Sign Score (0-65) * OLP Severity Index (0-20) * Numerical Rating Scale for pain (0-10) The total OLP-DAS score ranges from 0 to 95. Higher scores indicate worse disease activity.
1 secondary outcome
Product Satisfaction Questionnaire
Time frame: At 4 weeks after treatment start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pirawish Limlawan, D.D.S., Ph.D. principal investigator
Faculty of Dentistry, Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin in Nanogels and 0.1% Fluocinolone Acetonide Oral Paste in people with Oral Lichen Planus, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tossapol Maneethorn, D.D.S. (086-9253975, comeblack_ubama@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in OLP-DAS Score (time frame: Baseline, 2 weeks, and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.