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

Oral Lichen Planus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05882864
• Other study ID #: Herbs in oral medicine
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 1, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: May 2023
• Source: Ain Shams University
• Contact: Marwa Shehata, Bachelor
• Phone: +201007493498
• Email: marwa_dnt[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: August 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Intervention

Drug:
• 6-Gingerol
6-gingerol gel will be applied locally to the participants suffering from oral lichen planus
• Triamcinolone Acetonide 0.1% Oromucosal Paste
Triamcinolone Acetonide 0.1% gel will be applied locally to the participants suffering from oral lichen planus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

References & Publications (51)

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* Note: There are 51 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline

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