NCT07100145

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)

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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)
DRUG	Triamcinolone Acetonide	topical corticosteroid

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-09-01
• Completion: 2027-12-01
• First posted: 2025-08-03
• Last updated: 2025-08-06