Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus

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

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.

Study Overview

• Status: Completed
• Conditions: Erosive Lichen Planus
• Intervention / Treatment: Drug: Lycopene Softgel, 10 Mg; Drug: Prednisolone

Detailed Description

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
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21512
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lycopene	Drug: Lycopene Softgel, 10 Mg; 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.
Active Comparator: Corticosteroids	Drug: Prednisolone; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nourhan M.Aly
• Collaborators: Alexandria University
• Investigators: Principal Investigator: Aliaa A Bedeir, BDS, Faculty of Dentistry, Alexandria University, Egypt; Study Director: Azza M Zaki, PhD, Faculty of Dentistry, Alexandria University, Egypt; Study Director: Sabah A Mahmoud, PhD, Faculty of Medicine, Alexandria University, Egypt

Publications and helpful links

General Publications

• Thongprasom K, Luangjarmekorn L, Sererat T, Taweesap W. Relative efficacy of fluocinolone acetonide compared with triamcinolone acetonide in treatment of oral lichen planus. J Oral Pathol Med. 1992 Nov;21(10):456-8. doi: 10.1111/j.1600-0714.1992.tb00974.x.
• Gobbo M, Rupel K, Zoi V, Perinetti G, Ottaviani G, Di Lenarda R, Bevilacqua L, Woo SB, Biasotto M. Scoring systems for Oral Lichen Planus used by differently experienced raters. Med Oral Patol Oral Cir Bucal. 2017 Sep 1;22(5):e562-e571. doi: 10.4317/medoral.21833.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): March 3, 2019
• Study Completion (Actual): March 10, 2019

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: November 26, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: November 26, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Stomatognathic Diseases; Mouth Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Planus, Oral; Lichen Planus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protective Agents; Antioxidants; Anticarcinogenic Agents; Radiation-Protective Agents; Prednisolone; Lycopene
• Other Study ID Numbers: Lycopene and lichen planus

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No