Efficacy of Ginger Muco-bioadhesive Gel in Management of Oral Lichen Planus With Immunohistochemical Analysis

May 22, 2023 updated by: Ain Shams University

Efficacy of Ginger Muco-bioadhesive Gel in Management of Oral Lichen Planus: A Randomized Controlled Clinical Trial With Immunohistochemical Analysis

  1. Compare the clinical efficacy of topical ginger extract versus triamcinolone acetonide 0.1% for symptomatic oral lichen planus (Primary Objective).
  2. Investigate using immunohistochemical analysis the effect of the two different treatment modalities on FasL expression in oral lichen planus lesions (Secondary Objective).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ola Ezzat, Ass. Pro.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Males or females, aged from 40 to 60 years.
  • Clinically proven painful Bullous/erosive (score 4) or atrophic (score 3) forms of OLP confirmed by the presence of red or erythromatous changes, or shallow ulcerations with fine lacy lines at the periphery of the lesion accentuated by stretching and not eliminated by rubbing (Wickham's striae) (Lozada-Nur and Miranda, 1997)
  • Histopathologically, proven Bullous/erosive (score 4) or atrophic (score 3) forms of OLP confirmed by the presence of accepted histopathological criteria for lichen planus; basal cell liquefaction, band like lymphocytic infiltrate at the epithelial-stromal junction with degeneration of basal cell region (Ellis, 1967; Van der Meij and Van der Waal, 2003).

Exclusion Criteria:

  • History of drug induced lichenoid lesions.
  • Presence of systemic conditions as; serious active or recurrent infections, malignancy, diabetes mellitus, hypertension, or significant heart, liver, or renal diseases. Assessed using medical questionnaire guided by Cornell Medical Index (Pendleton et al., 2004).
  • Smoking.
  • Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation as mentioned in medical history.
  • Pregnancy or breast-feeding.
  • History of previous treatments potentially effective on OLP such as antimalarial agents, retinoids, corticosteroids or immunosuppressive drugs from less than 2 weeks for topical medications, and 4 weeks for systemic medications prior to starting the study (Swift et al., 2005).
  • Patients suffering from lichen planus skin lesions.
  • Loss of pliability or flexibility in the tissues involved by the oral lesions of lichen planus.
  • Histological signs of epithelial dysplasia or lichenoid lesions within the biopsied.
  • Refusing to participate in the study.
  • Vulnerable groups (handicapped, orphans and prisoners).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Topical 6-Gingerol Group
Group I Will include 14 patients receiving topical ginger extract 1% four times per day (after every meal and before going to bed) for eight weeks (Zakaria et al., 2020).
Drug: 6-Gingerol
6-gingerol gel will be applied locally to the participants suffering from oral lichen planus
Active Comparator: Topical Steroid Group

Group II Will include 14 patients receiving topical steroid (triamcinolone acetonide 0.1%) four times per day for eight weeks (Laeijendecker et al., 2006)

In the fourth and eighth weeks, topical anti-fungal will be applied by a third-party medical personnel to avoid 2ry candidiasis for this group.
Drug: Triamcinolone Acetonide 0.1% Oromucosal Paste
Triamcinolone Acetonide 0.1% gel will be applied locally to the participants suffering from oral lichen planus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Ginger Muco-bioadhesive Gel in Management of Oral Lichen Planus
Time Frame: Baseline
Analysis of 6-Gingerol gel in Management of Oral Lichen Plauns using Immunohistochemistry
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Herbs in oral medicine

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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