Adverse Cutaneous Reaction to Alternative Medical TherapyNCT03166241
Serum Interleukin -21 Level in Patients With Severe Adverse Cutaneous Drug Reaction.
A study testing serum interleukin 21, Complete Blood Picture and Liver function test in people with Adverse Cutaneous Reaction to Alternative Medical Therapy, run by Assiut University.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adverse Cutaneous Reaction to Alternative Medical Therapy
- What is being tested?
- serum interleukin 21, Complete Blood Picture and Liver function test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 20 patients presenting with adverse cutaneous drug reaction (Erythema multiforme, SJS and TEN )
- Patients with definite drug history.
- Both sex will be included.
Who cannot join
- 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,
Show all 10Show fewer
- Chronic liver or Renal diseases
- Atopy and Parathyroid disorders.
- Patients with known autoimmune diseases or cancer.
- Pregnant or lactating womens.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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.
- Being tested
- serum interleukin 21, Complete Blood Picture, Liver function test, Random Blood Sugar, Erythrocyte Sedimentation Rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum interleukin 21Diagnostic test
it is cytokine used as a marker to detect it's level in patients with adverse drug reactions
Complete Blood PictureDiagnostic test
It is a blood sample will taken from patients to detect any abnormalities in blood component at the start of the study
Liver function testDiagnostic test
It is a blood sample will taken from patients to detect any associated liver disease at the start of the study
Random Blood SugarDiagnostic test
measure blood sugar in patients included in the study at the start of the study
Erythrocyte Sedimentation RateDiagnostic test
blood sample will be taken from patients to detect any abnormalities in erythrocyte sedimentation rate at the start of the study
Kidney function testsDiagnostic test
blood sample will be taken from patients to detect any kidney disease before the start of the study
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | 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 Receives: 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 |
| control group | Placebo comparator | compare serum interleukin 21 level in patients with severe adverse drug reaction and healthy control subjects Receives: Diagnostic Test: serum interleukin 21 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study startJul 2017 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Adverse Cutaneous Reaction to Alternative Medical TherapyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MAHanna, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166241
- Sponsor's protocol ID
- ACDR
- Status last verified
- May 2017
- First submitted
- 22 May 2017
- Last updated
- 25 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 25709487Hidajat 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.
PubMed 25246464Ellender RP, Peters CW, Albritton HL, Garcia AJ, Kaye AD. Clinical considerations for epidermal necrolysis. Ochsner J. 2014 Fall;14(3):413-7.
PubMed 25249808Gong 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.
PubMed 24649038
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Interleukin -21 Level in Patients With Severe Adverse Cutaneous Drug Reaction and Correlation With Disease Severity.
- ClinicalTrials.gov ID
- NCT03166241
- Acronym / sponsor ID
- ACDR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 25 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | 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 testsmeasure 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 comparator | Diagnostic Test: serum interleukin 21compare serum interleukin 21 level in patients with severe adverse drug reaction and healthy control subjects |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 20 patients presenting with adverse cutaneous drug reaction (Erythema multiforme, SJS and TEN )
- Patients with definite drug history.
- Both sex will be included.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum interleukin 21it is cytokine used as a marker to detect it's level in patients with adverse drug reactions | Diagnostic test | control group, study group |
| Complete Blood PictureIt is a blood sample will taken from patients to detect any abnormalities in blood component at the start of the study | Diagnostic test | study group |
| Liver function testIt is a blood sample will taken from patients to detect any associated liver disease at the start of the study | Diagnostic test | study group |
| Random Blood Sugarmeasure blood sugar in patients included in the study at the start of the study | Diagnostic test | study group |
| Erythrocyte Sedimentation Rateblood sample will be taken from patients to detect any abnormalities in erythrocyte sedimentation rate at the start of the study | Diagnostic test | study group |
| Kidney function testsblood sample will be taken from patients to detect any kidney disease before the start of the study | Diagnostic test | study group |
Primary outcome
the patients with severe adverse cutaneous drug reaction who show change in serum interleukin 21 before and after therapy
Time frame: one month
blood sample will be taken from patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Results publication: PubMed 25709487Farshchian 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 publication: PubMed 25246464Hidajat 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 publication: PubMed 25249808Ellender RP, Peters CW, Albritton HL, Garcia AJ, Kaye AD. Clinical considerations for epidermal necrolysis. Ochsner J. 2014 Fall;14(3):413-7.
- Results publication: PubMed 24649038Gong 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing serum interleukin 21, Complete Blood Picture and Liver function test in people with Adverse Cutaneous Reaction to Alternative Medical Therapy, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fathya Ali, MD (01000197217, Askar21@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the patients with severe adverse cutaneous drug reaction who show change in serum interleukin 21 before and after therapy (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03166241, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2017.