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

Phase 4Not Yet RecruitingNCT07100145

Ain Shams University30 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Oral Lichen Planus

Eligibility

Sex: ALLMin age: 25 YearsMax age: 60 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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

Time frame: change from baseline two, four, eight and 12 weeks

Secondary Outcomes

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.

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