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IRCT20181005041243N2 IRCT 2022-10-12 Tehran University of Medical Sciences Effect of spironolactone and minoxidil solution in treatment of androgenic alopecia Efficacy and safety of minoxidil 5% with or without spironolactone 2% in treating patients with androgenic alopecia 2022-11-22 anticipated 60 Complete https://irct.ir/trial/66250 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individual blocks will be created without stratified randomization by statistical software (Website of SealedEnvelope TM). And another person (rather than the doctor-researcher-patient) would do the randomization. For this, blocks of size 6 were selected for 2 treatment groups so that the total sample size would be 60. Based on this, a randomized sequence will be provided according to which the study subjects will receive the treatment, Blinding description: The container containing the medicines will be without a drug name label and all the containers will be similar and indistinguishable. Another person out of the study will distribute the desired medicine to the patients based on the randomization sequence. Therefore, the physician, the outcome assessor, and the analyzer will remain unaware of the drug's content. According to the mentioned points, this study will be double-blind. 2-3 Androgenic alopecia. Intervention 1: Intervention group 1: minoxidil 5% solution/ The solution would be applied on the head twice a day (morning and night) for 6 months. This solution will be manufactured by the pharmacy of Razi Hospital. Intervention 2: Intervention group 2: spironolactone 2% solution plus minoxidil 5%/ The solution would be applied on the head twice a day (morning and night) for 6 months. This solution will be manufactured by the pharmacy of Razi Hospital. Yes - There is a plan to make this available What will be shared: The data file information of the participants - study protocol - statistical analysis plan - informed consent form will be published after de-identification. When: The access period starts 6 months after the results are published To whom: Receiving data will be available for researchers working in academic and scientific institutions or people who are also engaged in industry Conditions: In order to conduct scientific studies Where to obtain: Dr. Nika Kianfar nika_kianfar@yahoo.com How to obtain: After sending the request by providing a logical reason, the data will be sent to the person within 2 weeks. Comments:
public Nika Kianfar
No.1, afshar alley, daavi alley, pasdaran ave.
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0553 nika_kianfar@yahoo.com Tehran University of Medical Sciences scientific Nika Kianfar
No.1, afshar alley, daavi alley, pasdaran ave.
Tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0553 nika_kianfar@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Aged 18-60 Clinical diagnosis of androgenic alopecia with a dermatologist Have not received any drug for alopecia in the past 12 months 18 years 60 years Both Pregnancy or breastfeeding during the intervention history of internal diseases, including endocrine diseases causing alopecia alteration in diet and lifestyle during the study polycystic ovary syndrome The disease caused by another reason than androgenic alopecia Consuming any systemic or topical drugs which caused hair loss or hair regrowth Have a history of hair transplantation History of skin diseases which cause hair loss like cutaneous cancers, infection, psoriasis photosensitivity L64 Androgenic alopecia Treatment - Drugs Treatment - Drugs Intervention group 1: minoxidil 5% solution/ The solution would be applied on the head twice a day (morning and night) for 6 months. This solution will be manufactured by the pharmacy of Razi Hospital. Intervention group 2: spironolactone 2% solution plus minoxidil 5%/ The solution would be applied on the head twice a day (morning and night) for 6 months. This solution will be manufactured by the pharmacy of Razi Hospital. Hair regrrowth score. Timepoint: At the beginning of the study (before the start of the intervention) and 6 months after the start of trial. Method of measurement: Hair regrowth score based on the observations of two dermatologists assessing the before and after photographs. Patients' satisfaction with androgenic alopecia recovery. Timepoint: At the beginning of the study (before the start of the intervention) and 6 months after the start of trial. Method of measurement: Visual Analogue Scale. Hair regrowth score based on Fotofinder device. Timepoint: At the beginning of the study (before the start of the intervention) and 6 months after the start of trial. Method of measurement: Hair density (hairs/cm2) and Hair diameter (hairs/cm2). Tehran University of Medical Sciences Approved 2022-10-01 Ethics committee of Tehran University of Medical Sciences Vahdate eslami St. - Razi alley. Razi Dermatology Hospital Tehran Tehran Iran (Islamic Republic of)