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IRCT20190813044524N1 IRCT 2020-04-20 Tehran University of Medical Sciences Prednisolone maintenance therapy in pemphigus vulgaris. Comparison of the efficacy and side effects of low dose (≤10 mg/day) prednisolone maintenance therapy in pemphigus Vulgaris patients on remission with minimal prednisolone therapy and positive anti-desmoglein 1 and/or 3 antibodies referring to Razi Hospital, Tehran, Iran in 2020. 2020-04-27 anticipated 80 Complete https://irct.ir/trial/41948 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization was developed for randomization using the online tool https://www.sealedenvelope.com/simple-randomiser/v1/list s). In this tool, each patient is assigned a number and the patients are randomly divided into two groups. Participant number and group information is only available to the researcher, Blinding description: This study is a single-blind, controlled trial, and the trial is planned in a way that patients do not know belong to which of the two control or experimental groups. 3 Pemphigus vulgaris. Intervention 1: Intervention group: Group 1: Pemphigus Vulgaris patients with mild disease at diagnosis, who are on remission with prednisolone minimal therapy (≤10 mg/day which is used as 1or 2 tablet/s of 5 mg orally every daily/12 hours respectively) and their anti-desmoglein 1 and or 3 antibodies are positive and this drug will continue for 1 year. Prednisolone of Iran Hormone Company is being studied. Intervention 2: Control group: Pemphigus Vulgaris patients with mild disease at diagnosis, who are on remission with prednisolone minimal therapy (≤10 mg/day which is used as 1or 2 tablet/s of 5 mg orally every daily/12 hours respectively) their anti-desmoglein 1,3 antibodies are positive, and taper prednisolone. This drug will be discontinued for 1 year and will not receive any treatment. Prednisolone of Iran Hormone Company is being studied. Prednisolone of Iran Hormone Company is being studied. Intervention 3: Intervention group 2: Pemphigus Vulgaris patients with moderate-severe disease at diagnosis, who are on remission with prednisolone minimal therapy (≤10 mg/day which is used as 1or 2 tablet/s of 5 mg orally every daily/12 hours respectively) and their anti-desmoglein 1 and or 3 antibodies are positive, and this drug will continue for 1 year. Prednisolone of Iran Hormone Company is being studied. Prednisolone of Iran Hormone Company is being studied. Intervention 4: Control group 2: Pemphigus Vulgaris patients with moderate-severe disease at diagnosis, who are on remission with prednisolone minimal therapy (≤10 mg/day which is used as 1or 2 tablet/s of 5 mg orally every daily/12 hours respectively) their anti-desmoglein 1 and or 3 antibodies are positive and stop prednisolone. This drug will be discontinued for 1 year and will not receive any treatment. Prednisolone of Iran Hormone Company is being studied. Prednisolone of Iran Hormone Company is being studied. Yes - There is a plan to make this available What will be shared: All data are shareable, except for patients' pictures, after anonymizing the patients. When: All data are shareable 6 months after publishing the results. To whom: Researchers working in universities or science institutions or people working in industrial areas can receive the data or other documents on the study. Conditions: The data or the other documents on the research can be used for systematic review or any other purpose provided by having legal permission from the owners of the study. Where to obtain: Dr. Hamidreza Mahmoudi E-mail address: hr_mahmoody@yahoo.com Mobile-phone number: 00989122612946 How to obtain: Using the data or documents is possible after one month, provided having the legal permission of the owners of the study, by one of the authorized people. Comments:
public Hamidreza Mahmoudi
Razi Hospital, Razi Dead end, Vahdat Eslami Square, Vahdat Eslami Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0553 hr_mahmoody@yahoo.com Tehran University of Medical Sciences scientific Hamidreza Mahmoudi
Razi Hospital, Razi Dead end, Vahdat Eslami Square, Vahdat Eslami Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0553 hr_mahmoody@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Pemphigus vulgaris patients on remission phase. Under treatment with low dose prednisolone (5-10 mg/day) maintenance therapy. Positive anti-desmogleion 1 and/or 3. no limit no limit Both Pemphigus vulgaris patients with negative anti-desmogleion. Active phase of the disease L10.0 Pemphigus vulgaris Treatment - Drugs Treatment - Other Treatment - Drugs Treatment - Other Intervention group: Group 1: Pemphigus Vulgaris patients with mild disease at diagnosis, who are on remission with prednisolone minimal therapy (≤10 mg/day which is used as 1or 2 tablet/s of 5 mg orally every daily/12 hours respectively) and their anti-desmoglein 1 and or 3 antibodies are positive and this drug will continue for 1 year. Prednisolone of Iran Hormone Company is being studied. Control group: Pemphigus Vulgaris patients with mild disease at diagnosis, who are on remission with prednisolone minimal therapy (≤10 mg/day which is used as 1or 2 tablet/s of 5 mg orally every daily/12 hours respectively) their anti-desmoglein 1,3 antibodies are positive, and taper prednisolone. This drug will be discontinued for 1 year and will not receive any treatment. Prednisolone of Iran Hormone Company is being studied. Prednisolone of Iran Hormone Company is being studied. Intervention group 2: Pemphigus Vulgaris patients with moderate-severe disease at diagnosis, who are on remission with prednisolone minimal therapy (≤10 mg/day which is used as 1or 2 tablet/s of 5 mg orally every daily/12 hours respectively) and their anti-desmoglein 1 and or 3 antibodies are positive, and this drug will continue for 1 year. Prednisolone of Iran Hormone Company is being studied. Prednisolone of Iran Hormone Company is being studied. Control group 2: Pemphigus Vulgaris patients with moderate-severe disease at diagnosis, who are on remission with prednisolone minimal therapy (≤10 mg/day which is used as 1or 2 tablet/s of 5 mg orally every daily/12 hours respectively) their anti-desmoglein 1 and or 3 antibodies are positive and stop prednisolone. This drug will be discontinued for 1 year and will not receive any treatment. Prednisolone of Iran Hormone Company is being studied. Prednisolone of Iran Hormone Company is being studied. Continuation of the remission phase of the disease. Timepoint: Before starting the study,Every three months, End of the first year. Method of measurement: Direct examination by the a dermatologist so that the patient has no skin and/or mucosal manifestations. Diabetes. Timepoint: Before starting the study,Every three months, End of the first year. Method of measurement: Measurement of blood sugar over the past 3 month (HbA1C) and fasting blood sugar (FBS) and record information in the patient's file by the doctor. Osteoporosis. Timepoint: Before starting the study, End of the first year. Method of measurement: Perform bone mineral densitometry and record information in the patient's file by the physician. Increase in infection rate. Timepoint: Before starting the study,Every three months, End of the first year. Method of measurement: Question about history of the fever, loss of consciousness, headache, shortness of breath, cough, sore throat, abdominal pain, diarrhea and vomiting, dysuria and frequency, abnormal vaginal discharge, redness and warmth of the skin and record information in the patient's file by the physician. Weight gain. Timepoint: Before starting the study,Every three months, End of the first year. Method of measurement: The patient's weight is measured with the center scale and recorded in the patient's file by the physician. Cataract. Timepoint: Before starting the study,Every three months, End of the first year. Method of measurement: The question of blurred vision and its severity, if the answer is yes, we will refer her to an ophthalmologist to determine the extent of the conflict (Farabi Hospital).record information in the patient's file based on the sheet provided by the ophthalmologist by the researcher physician. Tehran University of Medical Sciences Approved 2019-09-02 ٍEthics committee of Tehran University of Medical Science Central Organization of Tehran University of Medical Sciences, Qods Ave, Keshavarz Blvd.,Tehran. Tehran Tehran Iran (Islamic Republic of)