Skip to main content
OpenTrials
Completed

NCT Number: NCT04652739

Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Erosive Lichen Planus

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Lycopene Softgel, 10 Mg

Drug

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.

Prednisolone

Drug

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).

Other names: Corticosteroids

Primary outcomes

  1. Pain assessment was conducted using Visual Analogue Scale (VAS)

    Time frame: up to 5 months

    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.

  2. Lesion size assessment

    Time frame: up to 5 months

    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.

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Collaborators

  • Alexandria University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 3, 2020
Registry last updated
Dec 3, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.