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