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

Lichen Planus Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04892381
• Other study ID #: 13111993
• Status: Not yet recruiting
• Start date: June 18, 2021
• Est. completion date: April 22, 2022

Study information

• Verified date: May 2021
• Source: Cairo University
• Contact: Rana A Mosaad, Msc
• Phone: 201096344429
• Email: ranaahmedmosaad[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 22, 2022
• Est. primary completion date: April 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lichen Planus

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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