Oral Lichen PlanusPhase 4NCT07100145
Efficacy of Coconut Gel Compared to Corticosteroid Gel in the Management of Oral Lichen Planus
A Phase 4 study testing Coconut oil and Triamcinolone Acetonide in people with Oral Lichen Planus, run by Ain Shams University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Coconut oil and Triamcinolone Acetonide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Nov 2025to 26 Sep 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinically and histologically proven Bullous/erosive or atrophic forms of OLP.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of dentistry Ain Shams University
Cairo, Cairo Governorate, 11757
About this study
Official title: 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
Read the 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.
- Conditions
- Oral Lichen Planus
- Being tested
- Coconut oil, Triamcinolone Acetonide
- Keywords
- Oral lichen planus, coconut oil, TNF-alpha, IL-10
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coconut oilOther
Also called coconut gel
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)
Triamcinolone AcetonideDrug
Also called kenalog in orabase
topical corticosteroid
| Study group | Role | What they receive |
|---|---|---|
| Topical coconut gel (50%) | Experimental | topical coconut gel (50%) four times per day (after every meal and before going to bed) for eight weeks Receives: Other: Coconut oil |
| Topical corticosteroid | Active comparator | topical corticosteroid (triamcinolone acetonide 0.1%) four times per day for eight weeks Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical score
0: represented no lesion/normal mucosa
- mild white striae/no erythematous area
- white striae with atrophic area less than 1 cm2
- white striae with atrophic area more than 1 cm2
- white striae with erosive area less than 1 cm2
- white striae with erosive area more than 1 cm2
Measured: change from baseline two, four, eight and 12 weeks
Secondary outcomes (1)
salivary levels of Tumor Necrosis Factor-alpha (TNF-α) and Interleukin-10 (IL-10)
The mean concentration of TNF-α and IL-10 in whole saliva of patients with OLP lesions will be measured by ELISA kit.
Measured: The Salivary Sample for each patient will be taken at baseline and after 2 months treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start11 Nov 2025
- Primary completion16 Aug 2026
- Study completion26 Sep 2026
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.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahenda Mahmoud Farid Mahmoud, Ain Shams University
- Investigators
- Nevine H Kheir El Din, Professor, Study director, faculty of dentistry Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100145
- Sponsor's protocol ID
- FDASU-Rec IM012414
- Status last verified
- Sep 2026
- First submitted
- 27 Jul 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Coconut Gel Compared to Corticosteroid Gel in the Management of Oral Lichen Planus (A Randomized Controlled Clinical Trial With Biochemical Analysis)
- ClinicalTrials.gov ID
- NCT07100145
- Acronym / sponsor ID
- FDASU-Rec IM012414
- Conditions
- Oral Lichen Planus
- Keywords
- Oral lichen planus, coconut oil, TNF-alpha, IL-10
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 16 Aug 2026 (actual)
- Study completion
- 26 Sep 2026 (actual)
- First posted
- 3 Aug 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.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical coconut gel (50%) | Experimental | Other: Coconut oiltopical coconut gel (50%) four times per day (after every meal and before going to bed) for eight weeks |
| Topical corticosteroid | Active comparator | Drug: Triamcinolone Acetonidetopical corticosteroid (triamcinolone acetonide 0.1%) four times per day for eight weeks |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Clinically and histologically proven Bullous/erosive or atrophic forms of OLP.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Coconut oilAlso: coconut gelThe 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 | Topical coconut gel (50%) |
| Triamcinolone AcetonideAlso: kenalog in orabasetopical corticosteroid | Drug | Topical corticosteroid |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No. Data is available upon reasonable request
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Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
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Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
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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. This study is not recruiting at the moment.
Nevine H Kheir El Din, Professor study director
faculty of dentistry Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coconut oil and Triamcinolone Acetonide in people with Oral Lichen Planus, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 9 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: finished, as of the sponsor's last update on 2 Oct 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical score (time frame: change from baseline two, four, eight and 12 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 2 Oct 2026.