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IRCT20200825048515N6 IRCT 2020-10-07 Esfahan University of Medical Sciences Comparison of the therapeutic effects of minoxidil solution alone with the combination of minoxidil and flutamide solution in patients with androgenic alopecia Comparison of therapeutic effects of 5% minoxidil solution alone with the combination of 5% minoxidil and flutamide solution in patients with androgenic alopecia 2020-10-22 anticipated 40 Complete https://irct.ir/trial/51449 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 40 eligible patients will be randomly selected. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of the two study groups, Blinding description: The two solutions of minoxidil and the combined solution of flutamide and minoxidil are already prepared by the pharmacist in the same volume and with the same color and shape, and are labeled A and B and will be given to the patients. Therefore, the patient and the researcher will not have any information about the two prescribed solutions. 3 Androgenic alopecia. Intervention 1: Intervention group: Patients in the first intervention group will take 1 cc (equivalent to 20 drops) of 5% minoxidil solution twice a day for 9 months. Intervention 2: Intervention group: Patients in the second intervention group will take 1 cc (equivalent to 20 drops) of the combined solution of 2% flutamide and 5% minoxidil twice a day for 9 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Gita Faghihi
Dermatology Department, Al-Zahra Hospital, Hezar Jarib Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 g_faghighi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Gita Faghihi
Dermatology Department, Al-Zahra Hospital, Hezar Jarib Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 g_faghighi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Confirmation of androgenic alopecia by two experienced dermatologists based on Hamilton diagnostic criteria Patient consent to participate in the study The intensity of hair loss in stage 2 to 5 according to Hamilton scale and in stages 1 and 2 according to Ludwig scale The duration of hair loss is less than 10 years 18 years 45 years Both History or observation of allergies to any of the drugs minoxidil and flutamide History of heart disease and use of antihypertensive drugs Receiving systemic treatment for androgenic alopecia during the 6 months prior to the study Other types of alopecia such as alopecia areata, telogen effluvium, anagen effluvium and scarring alopecia of any systemic cutaneous disease L64.9 Androgenic alopecia, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Patients in the first intervention group will take 1 cc (equivalent to 20 drops) of 5% minoxidil solution twice a day for 9 months. Intervention group: Patients in the second intervention group will take 1 cc (equivalent to 20 drops) of the combined solution of 2% flutamide and 5% minoxidil twice a day for 9 months. Hair density. Timepoint: Pre-and post-intervention. Method of measurement: Hair polarizer. Severity of hair loss. Timepoint: Pre-and post-intervention. Method of measurement: By a skilled physician based on Hamilton-Norwood scale for male pattern hair loss and Ludwig scale for female pattern hair loss. Isfahan University of Medical Sciences Approved 2019-07-03 Ethics committee of Isfahan University of Medical Sciences Hezar Jarib Ave, Azadi Square. Isfaha Isfehan Iran (Islamic Republic of)