Health TrialsbyHealthPanel

The Therapeutic Effect of Curcumin in Nanogels Compared to 0.1% FAO in the Management of Oral Lichen Planus

ConditionOral Lichen Planus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChulalongkorn University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Pregnancy or lactation

Current orthodontic treatment

Uncontrolled diabetes mellitus (HbA1c > 7% or FPG > 130 mg/dL)

Use of anticoagulants or antiplatelet agents

Trial design

Design model

Parallel

Treatments tested in this trial

  • Curcumin in Nanogels

    Drug

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

  • 0.1% Fluocinolone Acetonide Oral Paste

    Drug

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Curcumin GroupExperimental treatment 1 intervention
Group B: Fluocinolone Paste GroupActive comparator 1 intervention

Trial outcomes

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.

Time frame
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)

Time frame
At 4 weeks after treatment start

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chulalongkorn University

Lead sponsor

Source ClinicalTrials.gov
Apply now