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

NCT ID: NCT07100145

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-12-01

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Topical coconut gel (50%)

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

Group Type: EXPERIMENTAL

Coconut oil

Intervention Type: 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)

Topical corticosteroid

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

Group Type: ACTIVE_COMPARATOR

Triamcinolone Acetonide

Intervention Type: DRUG

topical corticosteroid

Interventions

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)

Intervention Type: OTHER

Triamcinolone Acetonide

topical corticosteroid

Intervention Type: DRUG

Other Intervention Names

coconut gel; kenalog in orabase

Eligibility Criteria

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).

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Shahenda Mahmoud Farid Mahmoud

Assistant lecturer of oral medicine and periodontology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nevine H Kheir El Din, Professor

Role: STUDY_DIRECTOR

faculty of dentistry Ain Shams University

Central Contacts

Shahenda M Farid, Ass.lecturer

Role: CONTACT

shahendamahmoud@dent.asu.edu.eg

01110399350

Radwa M Ragheb, Professor

Role: CONTACT

radwa.ragheb@dent.asu.edu.eg

01005524754

Other Identifiers

FDASU-Rec IM012414

Identifier Type: -

Identifier Source: org_study_id