Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus

Nourhan M.Aly20 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Erosive Lichen Planus

Interventions

Lycopene Softgel, 10 MgDRUG

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.

PrednisoloneDRUG

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).

Eligibility

Sex: ALLMin age: 30 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: up to 5 months

Data from ClinicalTrials.gov

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