Comparison of the effect of Cyclosporine and Etanercept on patients with TEN in Loghman Hakim hospital from 1398 to 1399
Evaluation of response rate to the treatment based on level of re-epithelization
Evaluation of response rate to the treatment based on total days of admission
Evaluation of response rate to the treatment based on total days of admission in ICU
Design
This study is a clinical trial in phase 2-3, on two groups of patients with toxic epidermal necrolysis. The sample size calculated in each group is 20 persons. Once the diagnosis is confirmed by a dermatologist, treatment begins with one group receiving cyclosporine and the other with etanercept. Simple randomization is done using a random number table.
Settings and conduct
This study performed on patients with toxic epidermal necrolysis referred to Loghman Hakim Hospital in 2020-2021. After examination by a dermatologist Patients admitted at the ICU ward of Loghman Hakim Hospital for their treatment. Skin biopsies and tests are performed for the patients. Daily examinations are performed by the dermatologist and resident. The whole data are recorded in the patient's file.
Participants/Inclusion and exclusion criteria
Patients with toxic epidermal necrolysis confirmed by dermatologist.
Intervention groups
Patients admitted with the diagnosis of toxic epidermal necrolysis are randomly divided into two treatment groups. One group receives 3 mg/kg daily cyclosporine and a single dose of 50mg etanercept subcutaneously is administered to the other group at the time of admission to the hospital.
Main outcome variables
The rate of re-epithelialization in patients lesions in each group which is defined as not having new lesions and an 80% improvement in previous lesions.
Number of days of admission.
Number of days of admission in ICU.
Mortality rate of patients based on SCORTEN.
Drugs complications in the patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191020045169N1
Registration date:2020-02-14, 1398/11/25
Registration timing:prospective
Last update:2020-02-14, 1398/11/25
Update count:0
Registration date
2020-02-14, 1398/11/25
Registrant information
Name
farnaz araghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2290 0421
Email address
farnazaraghi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of cyclosporine and etanercept on Toxic epidermal necrolysis
Public title
Comparison of the effect of cyclosporine and etanercept on Toxic epidermal necrolysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with toxic epidermal necrolysis confirmed by a dermatologist.
Exclusion criteria:
patients with any acquired or congenital immune deficiency.
patients with stage 3 or 4 of heart failure.
patients with uncontrolled hypertension.
patients with renal failure.
patients with known hypersensitivity to these drugs.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization by the table of random numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Bldg No.2 SBUMS, Arabi Ave, Velenjak, Tehran, Tehran Province
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-01-03, 1398/10/13
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.478
Health conditions studied
1
Description of health condition studied
toxic epidermal necrolysis
ICD-10 code
L51.2
ICD-10 code description
Toxic epidermal necrolysis [Lyell]
Primary outcomes
1
Description
leisions re-epithelialization of the toxic epidermal necrolysis
Timepoint
daily, during patients admission
Method of measurement
by dermatologist examination and taking standard pictures from patients lesions
Secondary outcomes
1
Description
Mortality rate of the patients
Timepoint
During their admission in the hospital
Method of measurement
SCORTEN index
Intervention groups
1
Description
Intervention group: toxic epidermal necrolysis patients, treated with etanercept 50mg(Ariogen pharmed) single dose subcutaneously on their first day of admission
Makhsus St., Qazvin St., Tehran., Tehran Province., Iran
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5541 9005
Email
loghman.hospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin zarghi
Street address
No.2., Arabi Ave., Velenjak., Tehran., Tehran Province., Iran.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farnaz Araghi
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Loghman hakim hospital., Makhsus., Makhsus St.، Qazvin St., , Tehran., Tehran Province, Iran.
City
Tehran
Province
Tehran
Postal code
1333631151
Phone
+98 21 5541 9005
Email
farnazaraghi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehdi Gheisari
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Loghman hakim hospital., Makhsus St., Qazvin St., Tehran., Tehran Province., Iran.
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5541 9005
Email
mgheisari@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farnaz Araghi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Loghman hakim hospital., Makhsus., Makhsus St.، Qazvin St., , Tehran., Tehran Province, Iran.
City
Tehran
Province
Tehran
Postal code
1333631151
Phone
+98 21 5541 9005
Email
farnazaraghi@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data is shareable after de-identification of participants.
When the data will become available and for how long
starting after publication for 6 months.
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
This information will only be available to authors of review and meta-analysis articles with citation.
From where data/document is obtainable
Email address of corresponding author
What processes are involved for a request to access data/document
The application should be sent to the email address with the approval of the relevant academic institution and confirming of article citation should be submitted before sending data.