Inclusion:
A) Patients with mild to moderate psoriasis (with PASI more than 10-15 and less than 30-40) with more than 10-15% involvement and whose disease is not so mild and limited to respond to routine topical treatment (they have received routine topical treatment and have not reached the minimum acceptable therapeutic response*), And it was not so severe and extensive that needs severe stage treatments (with too many side effects).
* Minimum acceptable therapeutic response: BSA less than 3% or BSA reduction greater than 75% (compared to the time of starting treatment) at 3 months after starting treatment.
B) Patients living in remote areas who cannot travel a long distance receive phototherapy 3 times a week and for a long period of time.
C) 30-50 years old
Exclusion:
Refusal to continue participation in the study
Past anaphylaxis history
Intervention groups
1. Main Treatment Group: monthly subcutaneous injection of two vials of Omalizumab 150 mg/5ml for six months.
2. Placebo Group: monthly injection of two vials of distilled water 5 ml for six months.
(A dermatologist will visit patients monthly in the first two months, and every two months in the next four months of the study. The clinical course of the disease will be evaluated in these visits.)
Main outcome variables
Psoriasis Area and Severity Index,PASI
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150716023235N18
Registration date:2023-09-26, 1402/07/04
Registration timing:registered_while_recruiting
Last update:2023-09-26, 1402/07/04
Update count:0
Registration date
2023-09-26, 1402/07/04
Registrant information
Name
Farahzad Jabbari Azad
Name of organization / entity
Allergy Research Center, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2770
Email address
jabbarif@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Omalizumab Therapeutic Effects in Mild to Moderate Psoriatic Patients Resistant to Routine Topical Treatments
Public title
Treatment with Omalizumab in Psoriatic Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild to moderate psoriasis (with PASI more than 10-15 and less than 30-40) with more than 10-15% involvement and whose disease is not so mild and limited to respond to routine topical treatment (they have received routine topical treatment and have not reached the minimum acceptable therapeutic response*), And it was not so severe and extensive that needs severe stage treatments (with too many side effects). *Minimum acceptable therapeutic response: BSA less than 3% or BSA reduction greater than 75% (compared to the time of starting treatment) at 3 months after starting treatment.
Patients living in remote area who cannot travel a long distance to receive phototherapy 3 times a week and for a long period of time.
30-50 years old
Exclusion criteria:
Prior history of Omalizumab injection
Prior history of receiving systemic treatments for psoriasis such as Methotrexate, Ciclosporin, Acitretin, Etanercept, Adalimumab, Infliximab, and Ustekinumab.
Prior history of phototherapy
Past anaphylaxis history
Age
From 30 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
The participants are divided into two groups by a simple randomization method using a table of random numbers tool. The randomization unit is individual. The random sequence is such that people who received an odd number enter the intervention group, and people with an even number are placed in the control group. Patients and outcome assessors will be unaware of the assigned numbers, and concealment will be performed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and outcome assessors (dermatologist and clinical allergist and immunologist) will be unaware of the assigned groups and double blinding will be performed. But the ward nurses who are responsible for injecting the intervention or placebo, as well as the data analyst, will not be blinded.
Even numbers (for the control group) and odd numbers (for the intervention group) are written in separate envelopes or written in the sheets and the sheet is folded so that it cannot be seen inside. Upon entry of each eligible patient, an envelope/sheet is removed and the patient is treated according to the number (group) inside.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research of Imam Reza Hospital, Vice Presidency of Mashhad University
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2023-08-14, 1402/05/23
Ethics committee reference number
IR.MUMS.IRH.REC.1402.114
Health conditions studied
1
Description of health condition studied
Psoriasis
ICD-10 code
L40.9
ICD-10 code description
Psoriasis, unspecified
Primary outcomes
1
Description
Psoriasis Severity
Timepoint
At 5 timepoints, before, during and after intervention (month O, 1, 2, 4, and 6)
Method of measurement
Psoriasis Area and Severity Index (PASI)
Secondary outcomes
1
Description
Dermatology Life Quality
Timepoint
Before intervention and after 6 months of intervention
Method of measurement
Dermatology Life Quality Index; DLQI
2
Description
Serum Total IgE Level
Timepoint
Before intervention and after 6 months of intervention
Method of measurement
Elisa
Intervention groups
1
Description
The main intervention group: for this group, 2 vials of omalizumab 150 mg per month (total of 300 mg per month) will be injected subcutaneously for 6 times with monthly intervals. The injection of this medicine will be done in the allergy department by the ward nurse under the supervision of the allergy and clinical immunology specialist. The volume of omalizumab vials will be 5 cc, for each injection, two vials will be drawn to a total volume of 10 cc inside a 10 cc syringe and will be injected subcutaneously. Patients will be monitored for signs of allergic reaction for 2 hours after injection, and then they will be discharged from the allergy department.
Category
Treatment - Drugs
2
Description
Control group: For this group, 2 vials of 5 cc distilled water will be injected intravenously 6 times at monthly intervals. Distilled water injection will be done in the allergy department by the ward nurse under the supervision of the allergy and clinical immunology specialist. The volume of the vials of distilled water will be 5 cc; for each injection, two vials totaling 10 cc will be drawn into a 10 cc syringe and injected intravenously. Patients will be monitored for signs of allergic reaction for 2 hours after injection, and then they will be discharged from the allergy department.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Allergy Clinic Ghaem Hospital
Full name of responsible person
Dr Farahzad Jabbari Azad
Street address
Ahmadabad street, at the Parastar corner
City
Mashhad
Province
Razavi Khorasan
Postal code
9919-91766
Phone
+98 915 316 7868
Email
jabbarif@mums.ac.ir
2
Recruitment center
Name of recruitment center
Dermatology clinic of Imam Reza hospital
Full name of responsible person
Shatila Torabi
Street address
Dermatology clinic of Imam Reza hospital, Daneshgah Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 915 513 1784
Email
TorabiSh@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi Piyadegheybi
Street address
Central Building of Mashhad University of Medical Sciences (Ghoreishi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mehraneh Movahedi Aliabadi
Position
Research assistant of the Allergy Research Center of Mashhad
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
Department of Immunology and Allergy, Hospital Ghaem, Ahmadabad streets, Mashhad Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9919-91766
Phone
+98 51 3801 2298
Fax
Email
movahhedam3@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farahzad Jabbari Azad, MD
Position
Professor, Director of the Allergy Research Center of Mashhad
Latest degree
Subspecialist
Other areas of specialty/work
Allergy and Clinical Immunology
Street address
Department of Immunology and Allergy, Hospital Ghaem, Ahmadabad streets, Mashhad Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9119-91766
Phone
+98 51 3845 8769
Fax
Email
Jabbarif@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mehraneh Movahedi Aliabadi
Position
Research assistant of the Allergy Research Center of Mashhad
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
Department of Immunology and Allergy, Hospital Ghaem, Ahmadabad streets, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9919-91766
Phone
+98 51 3801 2298
Fax
Email
movahhedam3@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Not applicable
When the data will become available and for how long
Not applicable
To whom data/document is available
Not applicable
Under which criteria data/document could be used
Not applicable
From where data/document is obtainable
Not applicable
What processes are involved for a request to access data/document