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IRCT20181226042136N1 IRCT 2019-01-15 Esfahan University of Medical Sciences Comparison of Betamethasone and Methotrexate efficacy in the Treatment of Alopecia Areata Comparative of Betamethasone pulse, Methotrexate pulse and Betamethasone Combination using Methotrexate pulse Therapy in Treatment of Severe Alopecia Areata 2017-06-22 anticipated 36 Complete https://irct.ir/trial/36367 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients whose entry criteria apply to them are numbered and the number of Habs based on the random numbers table is divided into three groups. Patients in the first group were treated with betamethasone pulse, the second group was treated with methotrexate pulse and the third group treated pulse combinations Methotrexate and Betamethasone, Blinding description: Patients, researchers and, evaluators will not be aware of the treatment groups, Medications are given to patients without a name and specification. Information will be provided to surveyors in the form of questionnaires delivered to the evaluators. The data is given for analysis as encoded and unnamed groups and profiles to the information analyzer. 3 Alopecia Areata. Intervention 1: Intervention group 1: The first group will be treated with 3 mg betamethasone per oral in the form of 0.5 mg tablets (made by Iran Hormones Co.) and with a dose of 1 mg for breakfast, lunch, and dinner on a specified day, weekly, for 6 months. Intervention 2: Intervention group 2: The second group will be treated with 15 mg methotrexate per oral in the form of 2.5 mg tablets (Ebetrex made by Pfizer Co ) and with a dose of 5 mg for breakfast, lunch and dinner, on a specified day, weekly, for 6 months. Intervention 3: Intervention group 3: The third group will be treated with 15 mg methotrexate per oral in the form of 2.5 mg tablets (Ebetrex made by Pfizer Co ) and with a dose of 5 mg for breakfast, lunch and dinner on a specified day(Friday) plus 3 mg betamethasone PO in the form of 0.5 mg tablets (made by Iran Hormones Co.) and with a dose of 1 mg for breakfast, lunch and dinner, on another specified day(Saturday), weekly, for 6 months. Yes - There is a plan to make this available What will be shared: The primary outcome data will be shared When: Start the access period is 6 months after publishing the results To whom: Academic researchers Conditions: The request can be made by e-mail to the corresponding author Where to obtain: It can be done by e-mail to z.ganjei@gmail.com How to obtain: Once the applicant has provided details of their ongoing project within one month from the time of application data will be available. Comments:
public Zakiye Ganjei
Soffe Blvd
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3668 5555 z.ganjei@gmail.com Esfahan University of Medical Sciences scientific Zakiye Ganjei
Soffe Blvd
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3668 5555 z.ganjei@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) The scalp involvement rate more than 50% The disease is resistant to systemic and topical combination therapy The patient is satisfied with the study 16 years 60 years Both Pregnancy or Breastfeeding Hb less than 9mg/dl Leukocyte less than 4000 Platelet less than 100000 Potassium is less than 3.5 Liver enzymes 2 times more than the reference limit ESR above reference limit Positive Stool Test for Strongyloides stercoralis Positive tests for viral hepatitis Use of any systemic drug a month before the start of the study There is a contraindication for betamethasone (diabetes, high blood pressure, drug allergy, active infection, recent surgery history, osteoporosis, stomach ulcer and psychosis, or depression) Sensitivity to methotrexate L63 Alopecia areata Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: The first group will be treated with 3 mg betamethasone per oral in the form of 0.5 mg tablets (made by Iran Hormones Co.) and with a dose of 1 mg for breakfast, lunch, and dinner on a specified day, weekly, for 6 months. Intervention group 2: The second group will be treated with 15 mg methotrexate per oral in the form of 2.5 mg tablets (Ebetrex made by Pfizer Co ) and with a dose of 5 mg for breakfast, lunch and dinner, on a specified day, weekly, for 6 months. Intervention group 3: The third group will be treated with 15 mg methotrexate per oral in the form of 2.5 mg tablets (Ebetrex made by Pfizer Co ) and with a dose of 5 mg for breakfast, lunch and dinner on a specified day(Friday) plus 3 mg betamethasone PO in the form of 0.5 mg tablets (made by Iran Hormones Co.) and with a dose of 1 mg for breakfast, lunch and dinner, on another specified day(Saturday), weekly, for 6 months. Photographic Scoring for patients with Alopecia Areata. Timepoint: Before the start of the study and 3 , 6, 9 months after the start of treatment. Method of measurement: Photographic Scoring. Visual Analogue Scale Score in patient with Alopecia Areata. Timepoint: Before the start of the study and 3 , 6, 9 months after the start of treatment. Method of measurement: Visual Analogue Scale. Esfahan University of Medical Sciences Approved 2017-06-22 Ethics committee of Isfahan University of Medical Sciences Soffeh Blvd Isfahan Isfehan Iran (Islamic Republic of)