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

Ain Shams University

Status and phase: Begins enrollment in 4 months; Phase 4

Conditions: Oral Lichen Planus

Treatments: Other: Coconut oil; Drug: Triamcinolone Acetonide

Study type: Interventional

Funder types: Other

Identifiers

NCT07100145

FDASU-Rec IM012414

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Topical coconut gel (50%)

Experimental group

Description:

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

Treatment:

Other: Coconut oil

Topical corticosteroid

Active Comparator group

Description:

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

Treatment:

Drug: Triamcinolone Acetonide