NCT06932848

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
0mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress96%
Jun 2025Jun 2026

First Submitted

Initial submission to the registry

April 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

April 10, 2025

Last Update Submit

March 4, 2026

Conditions

Oral Lichen Planus

Keywords

Atrophic-Erosive Oral Lichen PlanusCurcuminNanogelsFluocinolone AcetonideMucosal DiseaseAutoimmune Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 2 weeks, and 4 weeks

Secondary Outcomes (1)

  • Product Satisfaction Questionnaire

    At 4 weeks after treatment start

Study Arms (2)

Curcumin Group

EXPERIMENTAL

Curcumin nanogels applied 3 times daily for 4 weeks

Drug: Curcumin in Nanogels

Fluocinolone Paste Group

ACTIVE COMPARATOR

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

Drug: 0.1% Fluocinolone Acetonide Oral Paste

Interventions

Curcumin in NanogelsDRUG

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

Curcumin Group
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.

Fluocinolone Paste Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Chulalongkorn University

Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Conditions

Lichen Planus, OralAutoimmune Diseases

Interventions

CurcuminNanogels

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesLichen PlanusLichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicPolymersMacromolecular SubstancesGelsColloidsComplex MixturesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureNanocompositesNanostructuresNanoparticles

Study Officials

  • Pirawish Limlawan, D.D.S., Ph.D.

    Faculty of Dentistry, Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tossapol Maneethorn, D.D.S.

CONTACT

086-9253975comeblack_ubama@hotmail.com

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

CONTACT

084-090-3309pirawish@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2025

First Posted

April 17, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)