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

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: Not yet recruiting
• Conditions: Oral Lichen Planus
• Intervention / Treatment: Other: Coconut oil; Drug: Triamcinolone Acetonide

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: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Shahenda M Farid, Ass.lecturer; Phone Number: 01110399350; Email: shahendamahmoud@dent.asu.edu.eg
• Study Contact Backup: Name: Radwa M Ragheb, Professor; Phone Number: 01005524754; Email: radwa.ragheb@dent.asu.edu.eg

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	change from baseline two, four, eight and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The Salivary Sample for each patient will be taken at baseline and after 2 months treatment period

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Nevine H Kheir El Din, Professor, Faculty of Dentistry Ain Shams university

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 27, 2025
• First Submitted That Met QC Criteria: July 27, 2025
• First Posted (Actual): August 3, 2025

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: TNF-alpha; IL-10; Oral lichen planus; coconut oil
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Lichen Planus, Oral; Lichen Planus; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID 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