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

ConditionOral Lichen Planus
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age25-60
SponsorAin Shams University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinically and histologically proven Bullous/erosive or atrophic forms of OLP.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Coconut oil

    Other intervention

    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)

  • Triamcinolone Acetonide

    Drug

    topical corticosteroid

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Topical coconut gel (50%)Experimental treatment 1 intervention
Group B: Topical corticosteroidActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: