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IRCT20150716023235N18 IRCT 2023-09-26 Mashhad University of Medical Sciences Treatment with Omalizumab in Psoriatic Patients Evaluation of Omalizumab Therapeutic Effects in Mild to Moderate Psoriatic Patients Resistant to Routine Topical Treatments 2023-09-23 anticipated 20 Complete https://irct.ir/trial/68536 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 2 Psoriasis. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Not applicable When: Not applicable To whom: Not applicable Conditions: Not applicable Where to obtain: Not applicable How to obtain: Not applicable Comments:
public Mehraneh Movahedi Aliabadi
Department of Immunology and Allergy, Hospital Ghaem, Ahmadabad streets, Mashhad Mashhad
Mashhad Iran (Islamic Republic of) 9919-91766 +98 51 3801 2298 movahhedam3@mums.ac.ir Mashhad University of Medical Sciences scientific Farahzad Jabbari Azad, MD
Department of Immunology and Allergy, Hospital Ghaem, Ahmadabad streets, Mashhad Mashhad
Mashhad Iran (Islamic Republic of) 9119-91766 +98 51 3845 8769 Jabbarif@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 30 years 50 years Both 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 L40.9 Psoriasis, unspecified Treatment - Drugs Placebo 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. 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. 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). Dermatology Life Quality. Timepoint: Before intervention and after 6 months of intervention. Method of measurement: Dermatology Life Quality Index; DLQI. Serum Total IgE Level. Timepoint: Before intervention and after 6 months of intervention. Method of measurement: Elisa. Mashhad University of Medical Sciences Approved 2023-08-14 Ethics Committee in Biomedical Research of Imam Reza Hospital, Vice Presidency of Mashhad University Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)