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

Launched by AIN SHAMS UNIVERSITY · May 22, 2023

Keywords

ClinConnect Summary

This clinical trial is designed to compare the effectiveness of a topical ginger gel with a common steroid treatment called triamcinolone acetonide for managing a condition known as oral lichen planus (OLP). OLP can cause painful sores and changes in the mouth lining, and this study aims to see which treatment helps relieve pain and improve symptoms better. Additionally, researchers will analyze tissue samples to understand how these treatments affect certain markers in the lesions.

To participate in this study, individuals between the ages of 40 and 60 with confirmed painful forms of oral lichen planus may be eligible. However, those with certain health conditions, such as serious infections, diabetes, or a history of specific drug reactions, will not be able to join. Participants can expect to receive one of the two treatments and will undergo assessments to monitor their symptoms. This trial is currently not recruiting participants, but it represents a step towards finding new and potentially effective treatments for oral lichen planus.

Gender

ALL

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).