Estimation of Level of ERAP1 Expression in Lesional and Non Lesional Skin of Psoraitic Patients and Healthy Controls.

A 4mm Punch biopsy is obtained from lesional and non lesional skin of 25 psoraitic patients as well as of 30 controls.

Skin biopsy from patients (psoriasis lesional and non lesional) & control will be kept in lysis solution (which contains RNAase inhibitor) for the stability of the parameter to be assessed. ERAP-1 gene expression will Research Template 5 Final Version: 8/3/2 016 be detected by quantitative real time -PCR, which include RNA extraction, cDNA synthesis & PCR.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Diagnostic test: RT-PCR for ERAP1 detection

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with psoriasis vulgaris
• patients over 18 years of age
• both sexes

Exclusion Criteria:

• patients on treatment for psoriasis within the last two months
• assoiciated autoimmune diseases eg SLE
• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cases of psoriasis; group of 25 cases of psoriasis subjected to skin biopsy for detection of lesional and non lesional expression of ERAP1 by RT-PCR	Diagnostic test: RT-PCR for ERAP1 detection; Reverse transcriptase -Polymerase Chain Reaction for ERAP1 detection
Experimental: normal controls; group of 30 age and sex matched healthy controls o subjected to skin biopsy from normal skin for detection of expression of ERAP1 by RT-PCR	Diagnostic test: RT-PCR for ERAP1 detection; Reverse transcriptase -Polymerase Chain Reaction for ERAP1 detection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimation of lesional ERAP1 in psoriatic skin	DPCRetection of level of expression of ERAP 1 in lesional skin of psoriasis patients by RT-	Maximum 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimation of non lesional ERAP1 in psoriatic skin	Detection of level of expression of ERAP 1 in non lesional skin of psoriasis patients by RT-PCR.	Maximum 2 years

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): December 6, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: EgyERAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No