Background: Chronic urticaria is defined as urticaria persisting daily for more than six weeks, a significant number of them had autoimmune basis where autologous serum skin test is widely used for detection of chronic autoimmune urticaria.
Objectives: To estimate the frequency of autoimmune urticarial in Iraqi patients utilizing the autologous serum skin test and to evaluate its results with the variable clinical features of chronic idiopathic urticaria.
Methods: In this prospective study, 54 patients with chronic idiopathic urticaria will be investigated with autologous serum skin test where its results were examined with the different clinical parameters of chronic autoimmune urticaria.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013030912758N1
Registration date:2013-03-25, 1392/01/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-25, 1392/01/05
Registrant information
Name
Amar Hameed
Name of organization / entity
Baghdad medical college
Country
Iraq
Phone
7702475782- 00964
Email address
amar@uobaghdad.edu.iq
Recruitment status
Recruitment complete
Funding source
Iraqi Board for Medical specializations
Expected recruitment start date
2009-11-01, 1388/08/10
Expected recruitment end date
2013-11-01, 1392/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Autologous Serum Skin Test as a Diagnostic Aid in Chronic Idiopathic Urticaria
Public title
Investigation for chronic Idiopathic Urticaria
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: All patients with chronic idiopathic urticaria who have active urticaria at time of presentation and the current attack started at least six week before the test.
Exclusion criteria: children younger than 15 years of age and pregnant women were excluded from the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iraqi Board for Medical specializations
Street address
Medical Collection Office, P.O. Box 61080 Postal Code 12114, Baghdad, Iraq.
City
Baghdad
Postal code
12114
Approval date
2009-10-09, 1388/07/17
Ethics committee reference number
1976
Health conditions studied
1
Description of health condition studied
urticaria
ICD-10 code
L50.1
ICD-10 code description
Idiopathic urticaria
Primary outcomes
1
Description
wheal and flare
Timepoint
30 minutes after intradermal injection of 0.05 ml of the patient’s serum into patient’s forearm
Method of measurement
wheal and flare at the tested site of a diameter (measured by taking the mean of the largest two diameters) at least 1.5 millimeters more than the wheal and flare induced at the control site
Secondary outcomes
1
Description
wheal and flare
Timepoint
45 minutes after intradermal injection of the patient’s serum into patient’s forearm
Method of measurement
wheal and flare at the tested site of a diameter (measured by taking the mean of the largest two diameters) at least 1.5 millimeters more than the wheal and flare induced at the control site
Intervention groups
1
Description
The Autologous Serum Skin Test (ASST) was performed by drawing 2cubic centimeters of venous blood and stored in a plane tube(not heparinized) and allowed to clot at room temperature ,after that the serum is separated by centrifuging the blood in a centrifuge for 10 minutes at 2000 RPM (Revolution per Minute). 0.05 ml of the patient’s serum is injected intradermally on volar aspect of the patient’s forearm at site not affected by a wheal in the last 24 hours
Category
Diagnosis
2
Description
At the same time a control test is done by injecting the same volume of normal saline at least 5 centimeters away from the serum injection site
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghdad Teaching Hospital
Full name of responsible person
Dr.Ammar F.Hameed
Street address
Medical city 61106
City
Baghdad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iraqi Board for Medical specializations
Full name of responsible person
prof.Khalifa sharquie
Street address
Medical Collection Office, P.O. Box 61080
City
Baghdad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iraqi Board for Medical specializations
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Head of Department of Dermatology and Venereology, College of Medicine, University of Baghdad, Medic
Full name of responsible person
Professor Hayder R. Al-Hamamy
Position
Professor
Other areas of specialty/work
Street address
Medical city P.O. Box 61211.
City
baghdad
Province
baghdad
Postal code
12114
Phone
009647901309356
Fax
Email
Hayder317@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Dermatology-Baghdad University
Full name of responsible person
Dr.Ammar Faisal Hameed
Position
Lecturer
Other areas of specialty/work
Street address
Medical city61106
City
Baghdad
Province
Baghdad
Postal code
12114
Phone
009647702475782
Fax
Email
amar@uobaghdad.edu.iq
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Dermatology-Baghdad University
Full name of responsible person
Dr Ammar Faisal Hameed
Position
Lecturer
Other areas of specialty/work
Street address
Medical city 61106
City
baghdad
Province
baghdad
Postal code
12114
Phone
009647702475782
Fax
Email
amar@uobaghdad.edu.iq
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)