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Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus

Primary Purpose

Erosive Lichen Planus

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Lycopene Softgel, 10 Mg
Prednisolone
Sponsored by
Nourhan M.Aly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erosive Lichen Planus

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lycopene

Corticosteroids

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 26, 2020
Last Updated
November 26, 2020
Sponsor
Nourhan M.Aly
Collaborators
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04652739
Brief Title
Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus
Official Title
Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus (A Randomized Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
March 3, 2019 (Actual)
Study Completion Date
March 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nourhan M.Aly
Collaborators
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosive Lichen Planus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lycopene
Arm Type
Experimental
Arm Title
Corticosteroids
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lycopene Softgel, 10 Mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Other Intervention Name(s)
Corticosteroids
Intervention Description
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).
Primary Outcome Measure Information:
Title
Pain assessment was conducted using Visual Analogue Scale (VAS)
Description
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
Title
Lesion size assessment
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aliaa A Bedeir, BDS
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Azza M Zaki, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sabah A Mahmoud, PhD
Organizational Affiliation
Faculty of Medicine, Alexandria University, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
ZIP/Postal Code
21512
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
1460584
Citation
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.
Results Reference
background
PubMed Identifier
28809373
Citation
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.
Results Reference
background

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Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus

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