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IRCT20240920063104N1 IRCT 2024-10-12 Tehran University of Medical Sciences A comparative clinical trial study of the therapeutic effects and side effects of the two drugs Baricitinib and Tofacitinib in pediatric patients with Alopecia Areata A comparative clinical trial study of the therapeutic effects and side effects of the two drugs Baricitinib and Tofacitinib in pediatric patients with Alopecia Areata 2024-12-21 anticipated 48 Complete https://irct.ir/trial/79194 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a clinical trial and will be conducted on 48 pediatric patients with alopecia areata referred to Razi Hospital under the age of 18. After obtaining written consent from the parents, the patients will be randomly divided into 2 groups of 24 people according to the randomization table. The first group will be treated with tofacitinib 5 to 15 mg per day, the second group will be treated with baricitinib 2 to 4 mg per day. N/A Alopecia Areata. Intervention 1: Intervention group:children aged 2 to 18 years with alopecia areata receiving tofacitinib. Intervention 2: Intervention group: children aged 2 to 18 years with alopecia areata receiving Baricitinib. Yes - There is a plan to make this available What will be shared: Total potential data after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Scientific and academic researchers related to the field of dermatology, provided the data source is mentioned Where to obtain: alirezabanani1374@gmail.com How to obtain: Emailing identification documents and purposes of receiving data to the email address: alirezabanani1374@gmail.com Estimated time to send data: 1 week Comments:
public Alireza Banani
No. 14, Alley 46, Jamaluddin Asadabadi St., Yusuf Abad
Tehran Iran (Islamic Republic of) 1436773484 +98 21 8803 3928 alirezabanani1374@gmail.com Tehran University of Medical Sciences scientific Alireza Banani
No. 14, Alley 46, Jamaluddin Asadabadi St., Yusuf Abad
Tehran Iran (Islamic Republic of) 1436773484 +98 21 8803 3928 alirezabanani1374@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) 1) SALT score above 20% 2) Consent of the child's parent and signing of the consent form to enter the clinical trial 3) Possibility of regular follow-up in the clinic 2 years 18 years Both Existence of underlying systemic diseases Parents' lack of satisfaction with systemic treatment SALT score lower than 20 L63 Alopecia areata Treatment - Drugs Treatment - Drugs Intervention group:children aged 2 to 18 years with alopecia areata receiving tofacitinib Intervention group: children aged 2 to 18 years with alopecia areata receiving Baricitinib Comparison of the effects of Baricitinib and Tofacitinib in pediatric patients with alopecia areata. Timepoint: The beginning of the study, 1 month later, 3 months later and 6 months later. Method of measurement: According to clinical examination and SALT score. Comparison of the effects of baricitinib and tofacitinib in pediatric patients with alopecia areata. Timepoint: The beginning of the study, one month later, three months later and six months later. Method of measurement: Clinical examination and SALT score. Tehran University of Medical Sciences Approved 2024-08-19 Ethics Committee of School of Medicine - Tehran University of Medical Sciences No. 14, 46 Alley, Jamaluddin Asadabadi St., Yusuf Abad Tehran Tehran Iran (Islamic Republic of)