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

Adverse Cutaneous Reaction to Alternative Medical Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03166241
• Other study ID #: ACDR
• Status: Not yet recruiting
• Phase: N/A
• First received: May 22, 2017
• Last updated: May 23, 2017
• Start date: July 2017
• Est. completion date: December 2018

Study information

• Verified date: May 2017
• Source: Assiut University
• Contact: Fathya Ali, MD
• Phone: 01000197217
• Email: Askar21[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Adverse Cutaneous Reaction to Alternative Medical Therapy
• Drug-Related Side Effects and Adverse Reactions

Intervention

Diagnostic Test:
• serum interleukin 21
it is cytokine used as a marker to detect it's level in patients with adverse drug reactions
• 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
• Liver function test
It is a blood sample will taken from patients to detect any associated liver disease at the start of the study
• Random Blood Sugar
measure blood sugar in patients included in the study at the start of the study
• Erythrocyte Sedimentation Rate
blood sample will be taken from patients to detect any abnormalities in erythrocyte sedimentation rate at the start of the study
• Kidney function tests
blood sample will be taken from patients to detect any kidney disease before the start of the study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Ellender RP, Peters CW, Albritton HL, Garcia AJ, Kaye AD. Clinical considerations for epidermal necrolysis. Ochsner J. 2014 Fall;14(3):413-7. Review. — View 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. — View 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. Epub 2013 Sep 12. — View Citation

Hidajat C, Loi D. Drug-mediated rash: erythema multiforme versus Stevens-Johnson syndrome. BMJ Case Rep. 2014 Sep 22;2014. pii: bcr2014205543. doi: 10.1136/bcr-2014-205543. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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