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

NCT07100145 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: FDASU-Rec IM012414
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Oral Lichen Planus

Keywords

Oral lichen planus; coconut oil; TNF-alpha; IL-10

Outcome Measures

Primary Outcomes (1)

• clinical score

  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 Outcomes (1)

• salivary levels of Tumor Necrosis Factor-alpha (TNF-α) and Interleukin-10 (IL-10)

  The Salivary Sample for each patient will be taken at baseline and after 2 months treatment period

Study Arms (2)

Topical coconut gel (50%)

EXPERIMENTAL

topical coconut gel (50%) four times per day (after every meal and before going to bed) for eight weeks

Other: Coconut oil

Topical corticosteroid

ACTIVE COMPARATOR

topical corticosteroid (triamcinolone acetonide 0.1%) four times per day for eight weeks

Drug: Triamcinolone Acetonide

Interventions

Coconut oil OTHER

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)

Also known as: coconut gel

Topical coconut gel (50%)

Triamcinolone Acetonide DRUG

topical corticosteroid

Also known as: kenalog in orabase

Topical corticosteroid

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Coconut Oil; Triamcinolone Acetonide; Triamcinolone

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats; Fats; Lipids; Plant Oils; Oils; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Nevine H Kheir El Din, Professor

  faculty of dentistry Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Shahenda M Farid, Ass.lecturer

CONTACT

01110399350; shahendamahmoud@dent.asu.edu.eg

Radwa M Ragheb, Professor

CONTACT

01005524754; radwa.ragheb@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of oral medicine and periodontology department

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 3, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share