Efficacy of Coconut Gel Compared to Corticosteroid Gel in the Management of Oral Lichen Planus

August 1, 2025 updated by: Shahenda Mahmoud Farid Mahmoud, Ain Shams University

Efficacy of Coconut Gel Compared to Corticosteroid Gel in the Management of Oral Lichen Planus (A Randomized Controlled Clinical Trial With Biochemical Analysis)

In oral lichen planus ,Tumor necrosis factor-alpha (TNF-α) has a role in the progression of the disease, enhancing CD8+ cytotoxic T cells and plays a role in the malignant transformation of the lesion. IL-10 is an anti-inflammatory cytokine that controls the disease and maintain homeoastasis. Treatment for OLP includes corticosteroids which is the gold standard, although they have considerable side effects. The use of herbal medicine as an alternative therapy seems promising. Coconut oil has anti-inflammatory, antioxidant, and immunomodulatory properties, no adverse effects, easily available, cost-effective and simply extracted.The aim of this randomized controlled clinical trial is to compare the therapeutic effects of topical 50% coconut mucobioadhesive gel versus topical corticosteroid gel in the management of symptomatic OLP clinically and using biochemical analysis

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients with symptomatic OLP will be recruited in the study. Group 1, containing 15 patients will receive topical coconut oil while Group 2 containing 15 patients will receive topical corticosteroid four times per day for a period of 8 weeks. Clinical assessment including clinical score, area of marker lesion and visual analogue scale will be compared between the two groups. Salivary samples from patients in the two groups will be collected at baseline and after 8 weeks to assess the level of TNF-α and IL-10 biochemically using ELISA.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinically and histologically proven Bullous/erosive or atrophic forms of OLP.

Exclusion Criteria:

  • lichenoid lesions.
  • Presence of systemic conditions as; serious active or recurrent infections, malignancy, diabetes mellitus, hypertension, or significant heart, liver, or renal diseases.
  • Smoking.
  • Known hypersensitivity to the treatment drugs or any of the ingredients.
  • Pregnancy or breast-feeding.
  • History of previous treatments potentially effective on OLP such as antimalarial agents, retinoids, corticosteroids or immunosuppressive drugs in the last 2 weeks for topical medications, and 4 weeks for systemic medications prior to starting the study.
  • Loss of pliability or flexibility in the tissues involved by the oral lesions of lichen planus.
  • Histological signs of epithelial dysplasia or lichenoid lesions within the biopsied sites.
  • Vulnerable groups (handicapped, orphans and prisoners).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Topical coconut gel (50%)
topical coconut gel (50%) four times per day (after every meal and before going to bed) for eight weeks
Other: Coconut oil
The composition per 100 g of virgin coconut oil 50% in oral mucoadhesive gel will be coconut oil (50 ml), tween 20 (surfactant-2.5 g) or span 60 (surfactant-2.5 g), Carbopol 940 (gelling agent-1 g), triethanolamine (viscous organic compound-0.2 g) and vanillin (0.001 g)
Other Names:
  • coconut gel
Active Comparator: Topical corticosteroid
topical corticosteroid (triamcinolone acetonide 0.1%) four times per day for eight weeks
Drug: Triamcinolone Acetonide
topical corticosteroid
Other Names:
  • kenalog in orabase

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
clinical score
Time Frame: change from baseline two, four, eight and 12 weeks

0: represented no lesion/normal mucosa

  1. mild white striae/no erythematous area
  2. white striae with atrophic area less than 1 cm2
  3. white striae with atrophic area more than 1 cm2
  4. white striae with erosive area less than 1 cm2
  5. white striae with erosive area more than 1 cm2
change from baseline two, four, eight and 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
salivary levels of Tumor Necrosis Factor-alpha (TNF-α) and Interleukin-10 (IL-10)
Time Frame: The Salivary Sample for each patient will be taken at baseline and after 2 months treatment period
The mean concentration of TNF-α and IL-10 in whole saliva of patients with OLP lesions will be measured by ELISA kit.
The Salivary Sample for each patient will be taken at baseline and after 2 months treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nevine H Kheir El Din, Professor, Faculty of Dentistry Ain Shams university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FDASU-Rec IM012414

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data is available upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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