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NCT Number: NCT07100145

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

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

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Key information

Conditions

Oral Lichen Planus Lichen Planus Lichen Planus, Oral Lichenoid Eruptions Mouth Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Coconut oil

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)

Other names: coconut gel

Triamcinolone Acetonide

Drug

topical corticosteroid

Other names: kenalog in orabase

Primary outcomes

  1. clinical score

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

    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

Secondary outcomes

  1. salivary levels of Tumor Necrosis Factor-alpha (TNF-α) and Interleukin-10 (IL-10)

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

    The mean concentration of TNF-α and IL-10 in whole saliva of patients with OLP lesions will be measured by ELISA kit.

Study contacts

Contact information is provided by the study sponsor or research team.

Radwa M Ragheb, Professor

CONTACT

[email protected]

01005524754

Shahenda M Farid, Ass.lecturer

CONTACT

[email protected]

01110399350

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Efficacy of Coconut Gel Compared to Corticosteroid Gel in the Management of Oral Lichen Planus (A Randomized Controlled Clinical Trial With Biochemical Analysis)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 3, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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