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IRCT20221026056309N1 IRCT 2022-11-08 Iran University of Medical Sciences Investigating the effect of conditioning medium in the treatment of alopecia 15- Investigating the safety and effectiveness of the injection of conditioned medium derived from keratinocyte and fibroblast cells forascin compared to platelet rich plasma in the treatment of androgenic alopecia: a blinded randomized controlled interventional study 2022-11-21 anticipated 24 Complete https://irct.ir/trial/66490 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will have 2 containers. In one of the containers, there will be 24 numbers from 1 to 24, and in vase number 2, there will be 24 sealed envelopes, in which the desired type of treatment is inserted. The process of randomization will be that first we will choose a number randomly from the first container and we will choose an envelope randomly from the second container and put them in a designed box. The number removed from container #1 will take the treatment that was removed from container #2. We will do this for all 24 numbers. That is, we will have 24 numbers in the desired box, and in front of each number there will be an envelope with treatment inside. In this method, the type of intervention that exists inside each envelope is unclear, which is the randomization concealment method. In fact, the treatment assigned to the numbers is not known until the person comes and the envelope is opened for him, and secondly, the names of the treatments will not be clear inside the envelopes, and the names of the treatments will be A and B, and only the study designer He will know about the type of treatment A and B, Blinding description: The present study will be conducted in a double-blind manner, so that the doctor who scores the results of the study and the statistician do not know which treatment group the patient is placed in. 3 Androgenic alopecia. Intervention 1: Intervention group: The intervention group is treated with conditioned medium for 4 sessions with 1 month intervals. 4 ml of concentrated culture medium is used for each injection. Injection is done intradermally in areas with hair loss at half to one centimeter intervals using a 27-gauge insulin syringe. conditioned medium is derived from keratinocyte and fibroblast forascin cells. Intervention 2: Control group: The control group is treated with PRP for 4 sessions with 1 month intervals. 4 ml is used for each injection. Injection is done intradermally in areas with hair loss at half to one centimeter intervals using a 27-gauge insulin syringe. 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 -
public Elham Behrangi
Tehran Hemat Highway next to Milad Tower
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 86701 elham.behrangi@gmail.com Iran University of Medical Sciences scientific Elham Behrangi
Tehran Hemat Highway next to Milad Tower
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 86701 elham.behrangi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Men and women with hereditary hormonal hair loss Hamilton score 2-5 in men and Ludwig score 1-3 in women Complete consent of the patient to participate in the plan 18 years 50 years Both Platelet disorders or thrombocytopenia Patients receiving anticoagulants Receiving any topical or systemic medication in the last 3 months for hair loss L64 Androgenic alopecia Treatment - Drugs Treatment - Drugs Intervention group: The intervention group is treated with conditioned medium for 4 sessions with 1 month intervals. 4 ml of concentrated culture medium is used for each injection. Injection is done intradermally in areas with hair loss at half to one centimeter intervals using a 27-gauge insulin syringe. conditioned medium is derived from keratinocyte and fibroblast forascin cells. Control group: The control group is treated with PRP for 4 sessions with 1 month intervals. 4 ml is used for each injection. Injection is done intradermally in areas with hair loss at half to one centimeter intervals using a 27-gauge insulin syringe. Number of hairs. Timepoint: At the beginning of the study and 3 and 6 months after the end of the study. Method of measurement: by the hair analyzer. Hair thickness. Timepoint: At the beginning of the study and 3 and 6 months after the end of the study. Method of measurement: by the hair analyzer. Patient satisfaction score of treatment. Timepoint: At the beginning of the study and 3 and 6 months after the end of the study. Method of measurement: Using a standard scoring scale. The doctor's score is based on changing the standard photos. Timepoint: 3 and 6 months after completion of treatment. Method of measurement: Using a standard scoring scale. Stem Cell Research Center Approved 2022-05-22 Ethics Committee of the Faculty of Medicine of University of Iran Tehran Hemat Highway next to Milad Tower Tehran Tehran Iran (Islamic Republic of)