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

Serum Interleukin -21 Level in Patients With Severe Adverse Cutaneous Drug Reaction and Correlation With Disease Severity.

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

Study Overview

• Status: Unknown
• Conditions: Adverse Cutaneous Reaction to Alternative Medical Therapy
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one month

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• 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.
• Ellender RP, Peters CW, Albritton HL, Garcia AJ, Kaye AD. Clinical considerations for epidermal necrolysis. Ochsner J. 2014 Fall;14(3):413-7.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (Actual): May 25, 2017

Study Record Updates

• Last Update Posted (Actual): May 25, 2017
• Last Update Submitted That Met QC Criteria: May 23, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: ACDR

Drug and device information, study documents

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