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IRCT20141209020250N6 IRCT 2023-05-29 Vice chancellor of Research and Technology,Tehran University of Medical Sciences and Health Services Intralesional methotrexate injection in alopecia areata Evaluation of the efficacy and side effects of intralesional methotrexate injection in comparison with intralesional triamcinolone acetonide in patients with alopecia areata in patients referred to Razi Hospital in 2021-2022 2023-01-30 anticipated 40 Complete https://irct.ir/trial/60246 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment to intervention and control groups Limited randomization (Random Allocation Law) Randomization unit: individual The law of random assignment is the simplest method of limited randomization. This method represents a large block for the entire sample volume, which means that the balance in the number of people assigned to each group will be achieved at the end of the study. For this purpose, the researchers first determined a total sample size, then randomly selected groups assign them to group A and the rest to group B. For example, in a study with a sample size of 200 people, 100 balls for intervention group A and 100 balls for intervention group B are placed in a lottery container and then The balls are randomly removed from the container without replacement and the created sequence is recorded, Blinding description: A double-blind study is a study in which neither the participant nor the experimenter knows who is receiving which treatment. This method is used to prevent bias in the results. Double-blind research helps to reduce the effects of people's orientation on the research. This orientation can include the unwanted influence of the researcher on the way of collecting information or dividing people into groups. Researchers sometimes unintentionally interfere in the research process due to their feelings about the research path or personal interest in obtaining a specific result. Double-blind studies are usually conducted on humans, the factors that can bias the results of the experiment remain hidden from both the participant and the experimenter (or experimenters). In most cases, double-blind tests are performed in order to achieve a higher scientific standard. 3 Alopecia Areata. Intervention 1: Intervention group: a vial of methotrexate containing 25 mg/ml is used. After septic procedures, methotrexate is injected intradermally in the lesion itself and one centimeter around it with an injection volume of 0.02 ml per site. A maximum of 0.1-0.2 ml (2.5-5 mg) is injected per session using a 0.5 inch length. A 30 mm needle connected to an insulin syringe will be used. Intervention 2: Control group: The amount of intralesional steroids used is 40 mg/ml. One-fifth diluted triamcinolone acetonide (8 mg/ml) is injected intradermally in the lesion itself and one centimeter around it with an injection volume of 0.05-0.1 ml per site. A maximum of 2 ml (20 mg) is injected per session using a length of 0.5 inches. A 30 mm needle connected to an insulin syringe will be used. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Narges Ghandi
Razi Hospital, Vahdate- Eslami Av, Vahdate- Eslami Square
Tehran Iran (Islamic Republic of) ۱۱۹۹۶۶۳۹۱۱ +98 21 5561 8989 nghandi@tums.ac.ir Tehran University of Medical Sciences scientific Narges Ghandi
Razi Hospital, Vahdate- Eslami Av, Vahdate- Eslami Square
Tehran Iran (Islamic Republic of) ۱۱۹۹۶۶۳۹۱۱ +98 21 5561 8989 nghandi@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Adult patients (aged 16-60 years) Patients with alopecia areata who have less than 20% involvement of the scalp have not received any treatment for AA in the past 1 month. 16 years 60 years Both Children and patients under 16 years, pregnant and lactating women, chronic patients including patients with liver or blood disorders, patients with immunodeficiency, infectious disease patients with diffuse types (alopecia totalis, alopecia universalis and more than 20%) and positive pull tests that are candidates for systemic treatment patients who were treated for alopecia areata during the previous month Treatment - Drugs Treatment - Drugs Intervention group: a vial of methotrexate containing 25 mg/ml is used. After septic procedures, methotrexate is injected intradermally in the lesion itself and one centimeter around it with an injection volume of 0.02 ml per site. A maximum of 0.1-0.2 ml (2.5-5 mg) is injected per session using a 0.5 inch length. A 30 mm needle connected to an insulin syringe will be used. Control group: The amount of intralesional steroids used is 40 mg/ml. One-fifth diluted triamcinolone acetonide (8 mg/ml) is injected intradermally in the lesion itself and one centimeter around it with an injection volume of 0.05-0.1 ml per site. A maximum of 2 ml (20 mg) is injected per session using a length of 0.5 inches. A 30 mm needle connected to an insulin syringe will be used. Alopecia Areata severity index. Timepoint: The beginning of the study, one month, two months, three months, six months after the start of the study. Method of measurement: Viewing Dermoscopy criteria. Vice chancellor of Research and Technology,Tehran University of Medical Sciences and Health Services Approved 2022-02-12 Ethics committee of Tehran University of medical sciences Tehran University of Medical Sciences, Office of Vice Chancellor for Research and Technology, 6th floor, Ghods Street, Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)