Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus

Sponsor

Nourhan M.Aly (Other)

Overall Status

Completed

CT.gov ID

NCT04652739

Collaborator

Alexandria University (Other)

Enrollment

Location

Arms

5.3

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Erosive Lichen Planus	Drug: Lycopene Softgel, 10 Mg Drug: Prednisolone	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2018

Actual Primary Completion Date :

Mar 3, 2019

Actual Study Completion Date :

Mar 10, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pain assessment was conducted using Visual Analogue Scale (VAS) [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.
Lesion size assessment [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, Alexandria University	Alexandria		Egypt	21512

Sponsors and Collaborators

Nourhan M.Aly
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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Nourhan M.Aly, Assistant Lecturer of Dental Public Health, University of Alexandria

ClinicalTrials.gov Identifier:

NCT04652739

Other Study ID Numbers:

Lycopene and lichen planus

First Posted:

Dec 3, 2020

Last Update Posted:

Dec 3, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2020