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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 18, 2022

Detailed Description

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.

Interventions

  • Diagnostic Test: Skin Biopsy
    • 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

Arms, Groups and Cohorts

  • Lichen Planus group
    • 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
  • Control group
    • Assessment of Programmed Cell Death Protein 1 (PD-1) and Programmed Cell Death Ligand 1 (PD-L1) Tissue Expression Levels using ELISA

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: 12 months
    • Programmed Cell Death Protein 1 (PD-1) and Programmed Cell Death Ligand 1 (PD-L1) Tissue Expression Levels in Lichen Planus Patients

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Aya Mohamed Fahim, Dermatology Lecturer – Cairo University
  • Overall Official(s)
    • Rana A Misaad, Principal Investigator, Cairo University
  • Overall Contact(s)
    • Rana A Mosaad, Msc, 201096344429, ranaahmedmosaad@gmail.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.