Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus

NCT04652739 | Completed Phase 2

• 1 other identifier: Lycopene and lichen planus
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Erosive Lichen Planus

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Lycopene

EXPERIMENTAL

Drug: Lycopene Softgel, 10 Mg

Corticosteroids

ACTIVE COMPARATOR

Drug: Prednisolone

Interventions

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.

Lycopene

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).

Also known as: Corticosteroids

Corticosteroids

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Erosive oral lichen planus patients with severe and extensive painful erythematous, erosive and/ or ulcerative lesions who are in need for systemic corticosteroid therapy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related Publications (2)

• 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.

  PMID: 1460584 BACKGROUND

• 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.

  PMID: 28809373 BACKGROUND

MeSH Terms

Interventions

Prednisolone; Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Aliaa A Bedeir, BDS

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Azza M Zaki, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY DIRECTOR

• Sabah A Mahmoud, PhD

  Faculty of Medicine, Alexandria University, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 3, 2020
• Study Start: October 1, 2018
• Primary Completion: March 3, 2019
• Study Completion: March 10, 2019
• Last Updated: December 3, 2020

Record last verified: 2020-11

Locations

EG (1)