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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03166241
Recruitment Status : Unknown
Verified May 2017 by MAHanna, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : May 25, 2017
Last Update Posted : May 25, 2017
Sponsor:
Information provided by (Responsible Party):
MAHanna, Assiut University

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

Condition or disease Intervention/treatment Phase
Adverse Cutaneous Reaction to Alternative Medical Therapy Diagnostic Test: serum interleukin 21 Diagnostic Test: Complete Blood Picture Diagnostic Test: Liver function test Diagnostic Test: Random Blood Sugar Diagnostic Test: Erythrocyte Sedimentation Rate Diagnostic Test: Kidney function tests Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Serum Interleukin -21 Level in Patients With Severe Adverse Cutaneous Drug Reaction and Correlation With Disease Severity.
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: study group
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
Diagnostic Test: serum interleukin 21
it is cytokine used as a marker to detect it's level in patients with adverse drug reactions

Diagnostic Test: Complete Blood Picture
It is a blood sample will taken from patients to detect any abnormalities in blood component at the start of the study

Diagnostic Test: Liver function test
It is a blood sample will taken from patients to detect any associated liver disease at the start of the study

Diagnostic Test: Random Blood Sugar
measure blood sugar in patients included in the study at the start of the study

Diagnostic Test: Erythrocyte Sedimentation Rate
blood sample will be taken from patients to detect any abnormalities in erythrocyte sedimentation rate at the start of the study

Diagnostic Test: Kidney function tests
blood sample will be taken from patients to detect any kidney disease before the start of the study

Placebo Comparator: control group
compare serum interleukin 21 level in patients with severe adverse drug reaction and healthy control subjects
Diagnostic Test: serum interleukin 21
it is cytokine used as a marker to detect it's level in patients with adverse drug reactions




Primary Outcome Measures :
  1. the patients with severe adverse cutaneous drug reaction who show change in serum interleukin 21 before and after therapy [ Time Frame: one month ]
    blood sample will be taken from patients



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03166241


Contacts
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Contact: Fathya Ali, MD 01000197217 Askar21@yahoo.com
Contact: Hanan Ahmed, MD 01064447881 hanan-morsy2003@yahoo.com

Sponsors and Collaborators
Assiut University

Publications of Results:
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Responsible Party: MAHanna, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03166241    
Other Study ID Numbers: ACDR
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders