Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus

Study Overview
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Brief Summary
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The aim of this study was to evaluate the effect of oral lycopene and systemic steroids in the treatment of erosive oral lichen planus and compare between the two therapeutic modalities.

Detailed Description
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Twenty erosive lichen planus patients were recruited and randomly assigned in one of two groups, the test (lycopene) and control (corticosteroids) group.

Official Title
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Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus (A Randomized Clinical Trial)

Conditions
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Erosive Lichen Planus

Intervention / Treatment
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* Drug: Lycopene Softgel, 10 Mg
* Drug: Prednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Erosive oral lichen planus patients with severe and extensive painful erythematous, erosive and/ or ulcerative lesions who are in need for systemic corticosteroid therapy Exclusion Criteria: Pregnant females and smokers. Patients suggestive of having lichenoid contact/drug reactions. Patients suffering from any systemic disease as diabetes, liver disease, renal disease, any other autoimmune or collagen disease. Lesions showing histological features of dysplasia. Patients with skin lichen planus lesions.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lycopene<br> | Drug: Lycopene Softgel, 10 Mg<br>* Patients were given 10 mg of lycopene softgel capsules once daily for two months. The active ingredient in each capsule consists of 10 mg lycopene from natural tomato extract.<br>|
| Active Comparator: Corticosteroids<br> | Drug: Prednisolone<br>* Patients were given 40 mg of prednisolone tablets once daily in the morning for one month, afterwards, the dose was tapered along the following month. Incremental reduction of 10 mg each week for the first three weeks, followed by 5 mg reduction in the last week, was the tapering protocol in this study. The active ingredient in each tablet consists of Prednisolone metasulfobenzoate sodium 31.44 mg (equivalent to 20 mg of Prednisolone).<br>* Other names: Corticosteroids;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment was conducted using Visual Analogue Scale (VAS) | Patients were instructed to mark a 10 cm line at a point equivalent to their present pain. The score was determined by measuring the distance in mm on the line from the no pain anchor to the patient's mark, providing a range of scores from 0-100. A Pain-free experience was scored zero, while the worst pain was scored 100. | up to 5 months | 
| Lesion size assessment | Assessment of OLP lesions was performed using the Thongprasom et al. scoring index where: Score 0: No lesion/Normal mucosa. Score 1: Mild white striae only. Score 2: White striae with erythematous area <1cm². Score 3: White striae with erythematous area >1cm². Score 4: White striae with erosive area <1cm². Score 5: White striae with erosive area >1cm². Scores from different oral sites were added to give a final score for every patient from 0-50. | up to 5 months |