Clinical trial NCT04892381: Assessment of PD-1 and PD-L1Tissue Expression Levels in Lichen Planus Patients: A Case-Control Study
Official title: 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: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lichen Planus
Keywords: LP
PD-1
PD-L1
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * 30 male and female Lichen Planus patients.
* 30 male and female normal healthy Controls. Patients will be selected from Kasr Al-ainy, Dermatology Outpatient Clinic.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Rana A Misaad
role: PRINCIPAL_INVESTIGATOR
References: