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IRCT20240604062002N1 IRCT 2024-07-11 Tabriz University of Medical Sciences effects of rituximab in patients with pemphigus vulgaris with oral lesions systemic administration and intralesional injection of rituximab in patients with pemphigus vulgaris with oral lesions 2024-07-22 anticipated 20 Complete https://irct.ir/trial/77730 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization will be carried out on an individual basis by RandList software. The selection of patients will be based on sealed envelopes that be written A and B inside them. 20 envelopes will be prepared in two groups. After entering the clinic and before the visit, patients will receive the envelope from the secretary and hand it over to the physician. 2 Pemphigus vulgaris lesion. Intervention 1: Intervention group: First intervention: Systemic administration intervention where a 50 cc vial of rituximab containing 500 mg/50 ml is injected intravenously to patients four times with an interval of one week in a period of one month. Intervention 2: Intervention group: Second intervention: Systemic administration along with intralesional administration of 10 mg/ml on two occasions with an interval of 15 days. Yes - There is a plan to make this available What will be shared: The study data are classified and coded so that the names of the individuals cannot be identified. Access to all the study data will be possible except for the identifying information of the individuals. When: Access to study data after publication of the result is available in the journal To whom: Anyone interested in using the data can access the study data Conditions: Study data can be used for comparison with other results Where to obtain: Refer to the study's scientific or public accountability person for data. How to obtain: The request will be sent by email to person responsible for scientific or public inquiries. Comments:
public Dr. Faegheh Sheikhalizadeh Nobar
School of Medicine, Tabriz University of Medical Sciences, Golgasht street
Tabriz Iran (Islamic Republic of) 516369888 +98 41 1540 6612 faeghehsheikhalizadeh@gmail.com Tabriz University of Medical Sciences scientific Dr. Faegheh Sheikhalizadeh Nobar
School of Medicine, Tabriz University of Medical Sciences, Golgasht street
Tabriz Iran (Islamic Republic of) 516369888 +98 41 1540 6612 faeghehsheikhalizadeh@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) People over 18 years old with pemphigus vulgaris with oral lesions Patients who have not had a therapeutic response to corticosteroid administration Patients for whom rituximab has been started 18 years 80 years Both Pregnancy and breastfeeding People who have coagulation problems Patients with infection at the site of the lesion Rituximab contraindications include hypersensitivity to it or its components Having hepatitis B Having cardiovascular diseases Having malignant diseases L10.0 Pemphigus vulgaris Treatment - Drugs Treatment - Drugs Intervention group: First intervention: Systemic administration intervention where a 50 cc vial of rituximab containing 500 mg/50 ml is injected intravenously to patients four times with an interval of one week in a period of one month. Intervention group: Second intervention: Systemic administration along with intralesional administration of 10 mg/ml on two occasions with an interval of 15 days. Severity of pemphigus vulgaris lesion. Timepoint: Before the study, on the 15th day, 33 months after the injection. Method of measurement: PVLSS: Pemphigus Vulgaris Lesion Severity Score. Patient satisfaction. Timepoint: Before the study, on the 15th day, 33 months after the injection. Method of measurement: VAS: Visual analogue Scale. Tabriz University of Medical Sciences Approved 2024-06-24 Ethics Committee of Tabriz University of Medical Sciences Third floor, Central Building No.2, Tabriz University of Medical Sciences, Gholgasht street Tabriz East Azarbaijan Iran (Islamic Republic of)