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

Sponsor

Ain Shams University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05882864

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Oral Lichen Planus	Drug: 6-Gingerol Drug: Triamcinolone Acetonide 0.1% Oromucosal Paste	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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)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:

Double (Participant, Care Provider)

Masking Description:

The study is designed to be a prospective randomized double blind 2 parallel arms controlled clinical trial.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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).