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

Primary Purpose

Psoriasis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
RT-PCR for ERAP1 detection
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Psoriasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    cases of psoriasis

    normal controls

    Arm Description

    group of 25 cases of psoriasis subjected to skin biopsy for detection of lesional and non lesional expression of ERAP1 by RT-PCR

    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

    Outcomes

    Primary Outcome Measures

    Estimation of lesional ERAP1 in psoriatic skin
    DPCRetection of level of expression of ERAP 1 in lesional skin of psoriasis patients by RT-

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    December 5, 2018
    Last Updated
    December 5, 2018
    Sponsor
    Kasr El Aini Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03767114
    Brief Title
    Estimation of Level of ERAP1 Expression in Lesional and Non Lesional Skin of Psoraitic Patients and Healthy Controls.
    Official Title
    Estimation of Level of ERAP1 Expression in Lesional and Non Lesional Skin of Psoraitic Patients and Healthy Controls.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    June 2017 (Actual)
    Study Completion Date
    December 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kasr El Aini Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    55 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    cases of psoriasis
    Arm Type
    Experimental
    Arm Description
    group of 25 cases of psoriasis subjected to skin biopsy for detection of lesional and non lesional expression of ERAP1 by RT-PCR
    Arm Title
    normal controls
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    RT-PCR for ERAP1 detection
    Intervention Description
    Reverse transcriptase -Polymerase Chain Reaction for ERAP1 detection
    Primary Outcome Measure Information:
    Title
    Estimation of lesional ERAP1 in psoriatic skin
    Description
    DPCRetection of level of expression of ERAP 1 in lesional skin of psoriasis patients by RT-
    Time Frame
    Maximum 2 years
    Secondary Outcome Measure Information:
    Title
    Estimation of non lesional ERAP1 in psoriatic skin
    Description
    Detection of level of expression of ERAP 1 in non lesional skin of psoriasis patients by RT-PCR.
    Time Frame
    Maximum 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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