Oral Lichen Planus
Conditions
Brief 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).
Interventions
DRUG6-Gingerol
6-gingerol gel will be applied locally to the participants suffering from oral lichen planus
Triamcinolone Acetonide 0.1% gel will be applied locally to the participants suffering from oral lichen planus
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
The study is designed to be a prospective randomized double blind 2 parallel arms controlled clinical trial.
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)
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactMarwa Shehata, Bachelor
Backup ContactOla Ezzat, Ass. Pro.
Outcome results
None listed