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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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03166241
Enrollment
30
Registered
2017-05-25
Start date
2017-07-31
Completion date
2018-12-31
Last updated
2017-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Cutaneous Reaction to Alternative Medical Therapy

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.

Interventions

DIAGNOSTIC_TESTserum interleukin 21

it is cytokine used as a marker to detect it's level in patients with adverse drug reactions

DIAGNOSTIC_TESTComplete 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_TESTLiver function test

It is a blood sample will taken from patients to detect any associated liver disease at the start of the study

DIAGNOSTIC_TESTRandom Blood Sugar

measure blood sugar in patients included in the study at the start of the study

DIAGNOSTIC_TESTErythrocyte Sedimentation Rate

blood sample will be taken from patients to detect any abnormalities in erythrocyte sedimentation rate at the start of the study

DIAGNOSTIC_TESTKidney function tests

blood sample will be taken from patients to detect any kidney disease before the start of the study

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
the patients with severe adverse cutaneous drug reaction who show change in serum interleukin 21 before and after therapyone monthblood sample will be taken from patients

Contacts

Primary ContactFathya Ali, MD
Askar21@yahoo.com01000197217
Backup ContactHanan Ahmed, MD
hanan-morsy2003@yahoo.com01064447881

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026