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

NCT04892381 | Unknown

• 1 other identifier: 13111993
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Lichen Planus

Keywords

LP; PD-1; PD-L1

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Diagnostic Test: Skin Biopsy

Control group

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

Interventions

Skin Biopsy 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; Lichen Planus group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age group above 18 years old
• Patients of both genders
• Classic type of cutaneous LP.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (1)

• Elmasry MF, Mosaad RA, Azzam OA, Rashed LA, Fahim A. Assessment of PD-1 and PD-L1 tissue expression levels in lichen planus patients: a case-control study. Arch Dermatol Res. 2024 Mar 2;316(3):97. doi: 10.1007/s00403-024-02838-z.

  PMID: 38430309 DERIVED

MeSH Terms

Conditions

Lichen Planus

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rana A Misaad

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rana A Mosaad, Msc

CONTACT

201096344429; ranaahmedmosaad@gmail.com

Aya M Fahim, MD

CONTACT

201141443447; ayafahim2011@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatology Lecturer

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 19, 2021
• Study Start: June 18, 2021
• Primary Completion: April 18, 2022
• Study Completion: April 22, 2022
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)