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IRCT20230308057655N1 IRCT 2023-03-20 Esfahan University of Medical Sciences Comparison of the effectiveness of topical minoxidl and cetirizine in androgenetic alopecia Comparison of the effectiveness of the combined treatment of topical minoxidil and topical cetirizine solution with topical minoxidil alone in male and female patient with moderate to severe androgenetic alopecia 2023-04-04 anticipated 62 Complete https://irct.ir/trial/69139 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization in the study is a simple random method, in this way, using a computer system, 31 numbers are randomly selected from 1 to 62 for one group (A), and 31 numbers for the other group (B). then based on the order of entry of the patients into the study and the number they get based on the order of entry, which is related to which list, they are entered into one of these two groups (A or B). The pharmacy is aware of whether the intervention group (cetirizine + minoxidil) or the comparison group (minoxidil alone) is A and B and is blinded to the doctor, Blinding description: In order to blind the study, both cetirizine and minoxidil were given to the patients in the form of a solution and in the same packaging as numbers one and two, and the doctor did not know the type of medicine for each patient. (one-way blind method) The doctor secretly sent the patients with numbers A and B to the pharmacy, and only the pharmacist was aware of the type of treatment for these two groups, and at the end of the study and the end of the examinations, the type of treatment for each group will be revealed to the doctor. and B are each cetirizine and minoxidil or minoxidil alone). 3 Androgenetic Alopecia. Intervention 1: Intervention group: The intervention group is treated with topical cetirizine and topical minoxidil solution. First, 38 grams of cetirizine powder is prepared from Amin Pharmaceutical Company, then it is prepared by pharmacist in the form of a 1% cetirizine solution in alcohol base and it is provided to patients in a 120 cc solution package. After the initial examination, the patients start taking local treatment in the form of a 1% cetirizine solution once a day along with 5% minoxidil solution of the brand Pak Darou 2 times a day (morning and night) and after 4 months of treatment, re-evaluation and examination will be performed. Intervention 2: The control group was first examined and then treated with minoxidil 5 percent of the brand Pak Darou twice a day in the morning and at night and at the end of 4 months the evaluation and examination will be done again. 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 No decision has been made yet
public Somayeh Maleki
No. 26, Rozatian Ave., Kashani Blvd.
Isfahan Iran (Islamic Republic of) 7564184481 +98 31 3240 3979 drs.malekii92@gmail.com Esfahan University of Medical Sciences scientific Somayeh Maleki
No.26, Rozatian Ave., Kashani Blvd.,
Isfahan Iran (Islamic Republic of) 7564184481 +98 31 3240 3979 drs.malekii92@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) All patient with androgenetic alopecia aged 18 to 50 Patient who are willing to participate in trial 18 years 50 years Both Patient with other types of alopecia Any serious systemic disease Patient who have had a history of hair transplantation in the past History of sensitivity to cetirizine and minoxidil Systemic steroid use for more than 14 days in the last 2 monthes L64 Androgenic alopecia Treatment - Drugs Treatment - Drugs Intervention group: The intervention group is treated with topical cetirizine and topical minoxidil solution. First, 38 grams of cetirizine powder is prepared from Amin Pharmaceutical Company, then it is prepared by pharmacist in the form of a 1% cetirizine solution in alcohol base and it is provided to patients in a 120 cc solution package. After the initial examination, the patients start taking local treatment in the form of a 1% cetirizine solution once a day along with 5% minoxidil solution of the brand Pak Darou 2 times a day (morning and night) and after 4 months of treatment, re-evaluation and examination will be performed. The control group was first examined and then treated with minoxidil 5 percent of the brand Pak Darou twice a day in the morning and at night and at the end of 4 months the evaluation and examination will be done again. The increase in density and thickness of hair. Timepoint: before the start of treatment and 4 months after the start of treatment. Method of measurement: Trichogram and standard photography in 4 views. Patient satisfaction score, doctor satisfaction score. Timepoint: The beginning of the study and 4 months after the start of the study. Method of measurement: A 7-point questionnaire to check the level of patient and doctor satisfaction. Esfahan University of Medical Sciences Approved 2023-01-17 Ethics Committee of Isfahan University of Medical Sciences Sofeh St., Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)