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

Primary Purpose

Oral Lichen Planus

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
6-Gingerol
Triamcinolone Acetonide 0.1% Oromucosal Paste
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Lichen Planus

Eligibility Criteria

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

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Topical 6-Gingerol Group

    Topical Steroid Group

    Arm Description

    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).

    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.

    Outcomes

    Primary Outcome Measures

    Efficacy of Ginger Muco-bioadhesive Gel in Management of Oral Lichen Planus
    Analysis of 6-Gingerol gel in Management of Oral Lichen Plauns using Immunohistochemistry

    Secondary Outcome Measures

    Full Information

    First Posted
    May 22, 2023
    Last Updated
    May 22, 2023
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05882864
    Brief Title
    Efficacy of Ginger Muco-bioadhesive Gel in Management of Oral Lichen Planus With Immunohistochemical Analysis
    Official Title
    Efficacy of Ginger Muco-bioadhesive Gel in Management of Oral Lichen Planus: A Randomized Controlled Clinical Trial With Immunohistochemical Analysis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2025 (Anticipated)
    Study Completion Date
    August 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ain Shams 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
    Compare the clinical efficacy of topical ginger extract versus triamcinolone acetonide 0.1% for symptomatic oral lichen planus (Primary Objective). Investigate using immunohistochemical analysis the effect of the two different treatment modalities on FasL expression in oral lichen planus lesions (Secondary Objective).

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    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). Group II Will include 14 patients receiving topical steroid (triamcinolone acetonide 0.1%) four times per day for eight weeks (Laeijendecker et al., 2006)
    Masking
    ParticipantCare Provider
    Masking Description
    The study is designed to be a prospective randomized double blind 2 parallel arms controlled clinical trial.
    Allocation
    Randomized
    Enrollment
    28 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Topical 6-Gingerol Group
    Arm Type
    Active Comparator
    Arm Description
    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).
    Arm Title
    Topical Steroid Group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    6-Gingerol
    Intervention Description
    6-gingerol gel will be applied locally to the participants suffering from oral lichen planus
    Intervention Type
    Drug
    Intervention Name(s)
    Triamcinolone Acetonide 0.1% Oromucosal Paste
    Intervention Description
    Triamcinolone Acetonide 0.1% gel will be applied locally to the participants suffering from oral lichen planus
    Primary Outcome Measure Information:
    Title
    Efficacy of Ginger Muco-bioadhesive Gel in Management of Oral Lichen Planus
    Description
    Analysis of 6-Gingerol gel in Management of Oral Lichen Plauns using Immunohistochemistry
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marwa Shehata, Bachelor
    Phone
    +201007493498
    Email
    marwa_dnt@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ola Ezzat, Ass. Pro.

    12. IPD Sharing Statement

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

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