Evaluation of Desmoglein-3 Autoantibodies in the Tissues of Oral Lichen Planus and Correlation wi… (NCT06652477) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of Desmoglein-3 Autoantibodies in the Tissues of Oral Lichen Planus and Correlation with Disease Severity
20 participantsStarted 2024-11-05
Plain-language summary
1. evaluate the level of Dsg3 autoantibodies in tissue biopsy of Atrophic/Bullous Erosive (A/BE) OLP (Primary Objective).
2. correlate the severity of the disease with the level of tissue Dsg3 autoantibodies (Secondary Objective).
Who can participate
Age range40 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Males or females suffering from A/BE OLP. 2. Proven diagnosis of oral lichen planus based on criteria of WHO (World Health Organization) which is a clinical criteria, clinically proven painful A/BE form of OLP confirmed by the presence of red or erythematous 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).
Histopathologically, proven Bullous/erosive or reticular 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.
Exclusion Criteria:
* 1\. History of drug-induced lichenoid lesions. 2. Presence of systemic conditions such as serious active or recurrent infections, malignancy, diabetes mellitus, hypertension, or significant heart, liver, or renal diseases.
3\. Pregnancy or breastfeeding. 4. 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.
5\. Loss of pliability or flexibility in the tissues involved by the oral lesions of lichen planus.
6\. Histological signs of epithelial dysplasia or lichenoid lesions within the biopsied sites.
7\. Patient refuses…
What they're measuring
1
evaluate the level of Dsg3 autoantibodies in tissue biopsy of Atrophic/Bullous Erosive oral lichen planus
Timeframe: baseline
Trial details
NCT IDNCT06652477
SponsorAin Shams University
Sponsor typeOTHER
Study typeOBSERVATIONAL
Primary completion2024-12-05
Contact for this trial
Doaa Abd Elwadood Mohamed, master's degree student