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Serum Interleukin -21 Level in Patients With Severe Adverse Cutaneous Drug Reaction.

Primary Purpose

Adverse Cutaneous Reaction to Alternative Medical Therapy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
serum interleukin 21
Complete Blood Picture
Liver function test
Random Blood Sugar
Erythrocyte Sedimentation Rate
Kidney function tests
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adverse Cutaneous Reaction to Alternative Medical Therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 20 patients presenting with adverse cutaneous drug reaction (Erythema multiforme, SJS and TEN )
  • Patients with definite drug history.
  • Both sex will be included.

Exclusion Criteria:

  • Patients with a history of topical or systemic treatment (corticosteroids, intralesional steroid injection, immunosuppressive therapy).
  • Patients within 4 weeks of the study.
  • Patients receiving phototherapy within 6 months of the study.
  • Diabetic patients
  • Anaemic patients
  • Thyroid disorders,
  • Chronic liver or Renal diseases
  • Atopy and Parathyroid disorders.
  • Patients with known autoimmune diseases or cancer.
  • Pregnant or lactating womens.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    study group

    control group

    Arm Description

    measure serum interleukin 21 level in patients with severe adverse drug reaction who show change in serum interleukin 21 before and after therapy the following investigation will be done at the begning of the study to patients: Complete Blood Picture Erythrocyte Sedimentation Rate Random blood sugar Liver function tests Kidney function tests

    compare serum interleukin 21 level in patients with severe adverse drug reaction and healthy control subjects

    Outcomes

    Primary Outcome Measures

    the patients with severe adverse cutaneous drug reaction who show change in serum interleukin 21 before and after therapy
    blood sample will be taken from patients

    Secondary Outcome Measures

    Full Information

    First Posted
    May 22, 2017
    Last Updated
    May 23, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03166241
    Brief Title
    Serum Interleukin -21 Level in Patients With Severe Adverse Cutaneous Drug Reaction.
    Official Title
    Serum Interleukin -21 Level in Patients With Severe Adverse Cutaneous Drug Reaction and Correlation With Disease Severity.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2017 (Anticipated)
    Primary Completion Date
    July 2018 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    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
    Adverse cutaneous drug reactions are undesirable and typically unanticipated reactions independent of the intended therapeutic purpose of a medication. It may be either immunologic (eg, drug allergy) or non-immunologic. Adverse cutaneous drug reaction produce a wide range of clinical manifestations such as pruritus, maculopapular eruptions, urticaria, angioedema, phototoxic and photo allergic reactions, fixed drug reactions, erythema multiforme,vesiculobullous reactions (eg, Stevens-Johnson syndrome and toxic epidermal necrolysis) and serum sickness .They must be considered in the differential diagnosis of sudden symmetric eruption
    Detailed Description
    Erythema multiforme is an acute immune mediated disorder It is a type IV hypersensitivity reaction leading to dermal vasculitis. Erythema multiforme major usually as a result of medications such as sulphonamides, non-steroidal anti-inflammatories and penicillin and there is skin and mucosal involvement. Steven-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are considered a spectrum of acute life-threatening mucocutaneous reactions that differ only in severity. Both diseases are characterized by mucous membrane and skin involvement, are often caused by medications and are collectively known as epidermal necrolysis or scalded skin syndrome.Stevens-Johnson syndrome (SJS) is classified as an epidermal loss <10% of the body surface area.Toxic Epidermal Necrolysis (TEN) is indicated by >30% body surface area erosion. The range of epidermal loss between 10% and 30% is called Stevens-Johnson syndrome-Toxic Epidermal Necrolysis (SJS-TEN) overlap. Severity of illness score [Score of Toxic Epidermal Necrolysis(TEN) ] has been devised to predict prognosis in patients with Epidermal Necrolysis.This scoring system addresses 7 prognostic factors: age, malignancy, heart rate,Body Surface Area involved, serum urea, serum glucose and serum bicarbonate levels. Interleukin-21 regulates both innate and adaptive immune responses and it is not only has key roles in antitumour and antiviral responses that promote the development of autoimmune diseases and inflammatory disorders. It is recently discovered member of the type 1 cytokine family which is produced by activated clusters of differentiation 4+ T cells ,Natural killer cells and follicular helper T cells.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adverse Cutaneous Reaction to Alternative Medical Therapy

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    study group
    Arm Type
    Experimental
    Arm Description
    measure serum interleukin 21 level in patients with severe adverse drug reaction who show change in serum interleukin 21 before and after therapy the following investigation will be done at the begning of the study to patients: Complete Blood Picture Erythrocyte Sedimentation Rate Random blood sugar Liver function tests Kidney function tests
    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Arm Description
    compare serum interleukin 21 level in patients with severe adverse drug reaction and healthy control subjects
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    serum interleukin 21
    Intervention Description
    it is cytokine used as a marker to detect it's level in patients with adverse drug reactions
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Complete Blood Picture
    Intervention Description
    It is a blood sample will taken from patients to detect any abnormalities in blood component at the start of the study
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Liver function test
    Intervention Description
    It is a blood sample will taken from patients to detect any associated liver disease at the start of the study
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Random Blood Sugar
    Intervention Description
    measure blood sugar in patients included in the study at the start of the study
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Erythrocyte Sedimentation Rate
    Intervention Description
    blood sample will be taken from patients to detect any abnormalities in erythrocyte sedimentation rate at the start of the study
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Kidney function tests
    Intervention Description
    blood sample will be taken from patients to detect any kidney disease before the start of the study
    Primary Outcome Measure Information:
    Title
    the patients with severe adverse cutaneous drug reaction who show change in serum interleukin 21 before and after therapy
    Description
    blood sample will be taken from patients
    Time Frame
    one month

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 20 patients presenting with adverse cutaneous drug reaction (Erythema multiforme, SJS and TEN ) Patients with definite drug history. Both sex will be included. Exclusion Criteria: Patients with a history of topical or systemic treatment (corticosteroids, intralesional steroid injection, immunosuppressive therapy). Patients within 4 weeks of the study. Patients receiving phototherapy within 6 months of the study. Diabetic patients Anaemic patients Thyroid disorders, Chronic liver or Renal diseases Atopy and Parathyroid disorders. Patients with known autoimmune diseases or cancer. Pregnant or lactating womens.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fathya Ali, MD
    Phone
    01000197217
    Email
    Askar21@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hanan Ahmed, MD
    Phone
    01064447881
    Email
    hanan-morsy2003@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25709487
    Citation
    Farshchian M, Ansar A, Zamanian A, Rahmatpour-Rokni G, Kimyai-Asadi A, Farshchian M. Drug-induced skin reactions: a 2-year study. Clin Cosmet Investig Dermatol. 2015 Feb 9;8:53-6. doi: 10.2147/CCID.S75849. eCollection 2015.
    Results Reference
    result
    PubMed Identifier
    25246464
    Citation
    Hidajat C, Loi D. Drug-mediated rash: erythema multiforme versus Stevens-Johnson syndrome. BMJ Case Rep. 2014 Sep 22;2014:bcr2014205543. doi: 10.1136/bcr-2014-205543.
    Results Reference
    result
    PubMed Identifier
    25249808
    Citation
    Ellender RP, Peters CW, Albritton HL, Garcia AJ, Kaye AD. Clinical considerations for epidermal necrolysis. Ochsner J. 2014 Fall;14(3):413-7.
    Results Reference
    result
    PubMed Identifier
    24649038
    Citation
    Gong F, Su Q, Pan YH, Huang X, Shen WH. The emerging role of interleukin-21 in allergic diseases (Review). Biomed Rep. 2013 Nov;1(6):837-839. doi: 10.3892/br.2013.166. Epub 2013 Sep 12.
    Results Reference
    result

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    Serum Interleukin -21 Level in Patients With Severe Adverse Cutaneous Drug Reaction.

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