Assessment of PD-1 and PD-L1Tissue Expression Levels in Lichen Planus Patients: A Case-Control Study

Study Overview
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Brief Summary
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Assessment of Programmed Cell Death Protein 1 (PD-1) and Programmed Cell Death Ligand 1 (PD-L1) Tissue Expression Levels in Lichen Planus Patients: A Case-Control Study

Detailed Description
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This prospective Case Control study will be conducted at Kasr Al-Aini Dermatology Outpatient Clinics and will include 30 LP patients and 30 normal healthy controls which will be recruited and assessed for eligibility for inclusion according to the above criteria. All participants (patients & controls) will be subjected to the following: Written informed consent. Detailed history including onset, course, duration of the disease and history of drug intake within 1 month before the eruption. Clinical assessment of the Severity by using LP Severity Index (LPSI) (Kaur et al., 2020). Skin biopsy will be taken under local anesthesia : From each normal control; a 3 mm punch skin biopsy from a sun protected area will be taken and preserved in PBS and kept frozen at -80 degrees Celsius for ELISA study. From each LP patient; two punch skin biopsies will be taken and preserved in PBS and kept frozen at -80 degrees Celsius for ELISA study: i. The first biopsy will be a 3 mm punch biopsy from the center of LP lesional skin of sun protected area ii. The second biopsy will be a 3 mm punch biopsy from non lesional skin at least 15 cm away from the edge of any existing LP lesion of sun protected area The level of PD1 and PD-L1 will be detected using ELISA technique. The lesional biopsy will be assessed by routine hematoxylin and eosin (H&E) to confirm the diagnosis of LP Patients' serial numbers only will be used on data collection sheets and ELISA specimens' labels. Data will be entered on a computer with access limited to the researchers in order to ensure confidentiality of patients' information and lab results.

Official Title
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Assessment of Programmed Cell Death Protein 1 (PD-1) and Programmed Cell Death Ligand 1 (PD-L1) Tissue Expression Levels in Lichen Planus Patients: A Case-Control Study

Conditions
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Lichen Planus

Intervention / Treatment
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* Diagnostic Test: Skin Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age group above 18 years old Patients of both genders Classic type of cutaneous LP. Exclusion criteria: Topical treatment for LP 2 weeks before enrollment in the study or systemic treatment for LP 4 weeks before enrollment in the study and 3 years for systemic retenoids. Actinic LP , LP pigmentosus and Mucosal only LP Drug induced lichenoid eruption Conditions precluding taking skin biopsy : bleeding tendency , lidocaine allergy PD-1 associated-diseases e.g.: SLE, Cancers including melanoma and non-melanoma skin cancers, and Bullous Pemphigoid

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lichen Planus group<br>Assessment of Programmed Cell Death Protein 1 (PD-1) and Programmed Cell Death Ligand 1 (PD-L1) Tissue Expression Levels using ELISA in lesional and non lesional skin | Diagnostic Test: Skin Biopsy<br>* Skin biopsy will be taken under local anesthesia : From each normal control; a 3 mm punch skin biopsy from a sun protected area will be taken and preserved in PBS and kept frozen at -80 degrees Celsius for ELISA study. From each LP patient; two punch skin biopsies will be taken and preserved in PBS and kept frozen at -80 degrees Celsius for ELISA study: i. The first biopsy will be a 3 mm punch biopsy from the center of LP lesional skin of sun protected area ii. The second biopsy will be a 3 mm punch biopsy from non lesional skin at least 15 cm away from the edge of any existing LP lesion of sun protected area The level of PD1 and PD-L1 will be detected using ELISA technique. The lesional biopsy will be assessed by routine hematoxylin and eosin (H&E) to confirm the diagnosis of LP<br>|
| Control group<br>Assessment of Programmed Cell Death Protein 1 (PD-1) and Programmed Cell Death Ligand 1 (PD-L1) Tissue Expression Levels using ELISA | Diagnostic Test: Skin Biopsy<br>* Skin biopsy will be taken under local anesthesia : From each normal control; a 3 mm punch skin biopsy from a sun protected area will be taken and preserved in PBS and kept frozen at -80 degrees Celsius for ELISA study. From each LP patient; two punch skin biopsies will be taken and preserved in PBS and kept frozen at -80 degrees Celsius for ELISA study: i. The first biopsy will be a 3 mm punch biopsy from the center of LP lesional skin of sun protected area ii. The second biopsy will be a 3 mm punch biopsy from non lesional skin at least 15 cm away from the edge of any existing LP lesion of sun protected area The level of PD1 and PD-L1 will be detected using ELISA technique. The lesional biopsy will be assessed by routine hematoxylin and eosin (H&E) to confirm the diagnosis of LP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the level of PD-1 and PD-L1 in the lesional and in non lesional skin in LP patients compared to normal controls | Programmed Cell Death Protein 1 (PD-1) and Programmed Cell Death Ligand 1 (PD-L1) Tissue Expression Levels in Lichen Planus Patients | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LP, PD-1, PD-L1