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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-18

Study Completion Date

2022-04-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Expression of miRNa-138 and Cyclin D1 in Oral Mucosa of Patients With Oral Lichen Planus

NCT02834520

Oral Lichen Planus

COMPLETED

Gene Polymorphism in Tinea Versicolor

NCT04769804

Recurrent Pityriasis Versicolor

UNKNOWN

Cellular and Molecular Biomarkers in Patients With Lichen Planus

NCT06451744

Lichen Planus

RECRUITING NA

Methods Validation Assessment for Study of Inflammatory Skin Disease

NCT03796806

Lichen Planus

COMPLETED

Tissue and Serum Level of NLRP1, NLRP3 and Il-18 in Early Stages of mf Patients

NCT06066554

Early Disease Onset

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lichen Planus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Skin Biopsy

Intervention Type DIAGNOSTIC_TEST

* 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

Control group

Assessment of Programmed Cell Death Protein 1 (PD-1) and Programmed Cell Death Ligand 1 (PD-L1) Tissue Expression Levels using ELISA

Skin Biopsy

Intervention Type DIAGNOSTIC_TEST

* 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes