Serum Interleukin -21 Level in Patients With Severe Adverse Cutaneous Drug Reaction.
1 other identifier
interventional
30
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2017
CompletedFirst Posted
Study publicly available on registry
May 25, 2017
CompletedStudy Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMay 25, 2017
May 1, 2017
1 year
May 22, 2017
May 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
study group
EXPERIMENTALmeasure 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
control group
PLACEBO COMPARATORcompare serum interleukin 21 level in patients with severe adverse drug reaction and healthy control subjects
Interventions
it is cytokine used as a marker to detect it's level in patients with adverse drug reactions
It is a blood sample will taken from patients to detect any abnormalities in blood component at the start of the study
It is a blood sample will taken from patients to detect any associated liver disease at the start of the study
measure blood sugar in patients included in the study at the start of the study
blood sample will be taken from patients to detect any abnormalities in erythrocyte sedimentation rate at the start of the study
blood sample will be taken from patients to detect any kidney disease before the start of the study
Eligibility Criteria
You may qualify if:
- patients presenting with adverse cutaneous drug reaction (Erythema multiforme, SJS and TEN )
- Patients with definite drug history.
- Both sex will be included.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
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.
PMID: 25709487RESULTHidajat 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.
PMID: 25246464RESULTEllender RP, Peters CW, Albritton HL, Garcia AJ, Kaye AD. Clinical considerations for epidermal necrolysis. Ochsner J. 2014 Fall;14(3):413-7.
PMID: 25249808RESULTGong 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.
PMID: 24649038RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 22, 2017
First Posted
May 25, 2017
Study Start
July 1, 2017
Primary Completion
July 1, 2018
Study Completion
December 1, 2018
Last Updated
May 25, 2017
Record last verified: 2017-05