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IRCT20210612051545N5 IRCT 2022-12-30 Tehran University of Medical Sciences Placenta extract in the treatment of androgenetic hair loss Clinical trial of safety and effectiveness of subcutaneous injection of placenta extract in the treatment of androgenetic hair loss 2022-11-22 anticipated 30 Complete https://irct.ir/trial/66697 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples will be randomized according to block randomization design with block size of 4 using Random Allocation Software. In this regard, using the software, the allocation sequence is generated based on the selected block type. Blocking and allocation sequence will be done for concealment by a person which is not involved in the research. The allocation ratio of the samples will be 1:1 and will be placed in two groups receiving drug and placebo. Then based on the obtained blocks and sequence of allocation, drug or placebo will be given to the patients by the sealed enveloped method, Blinding description: In this study, patients, researcher, physician, nurse and the evaluator are blinded until the end of the study. For this purpose, a code is assigned to the drug or placebo and it is sent to the physician in a covered form with a code. The physician performs the injection for the patient based on the table of random numbers. The patient's medical record is defined as a code, and the patient and the evaluator will not know the type of medicine. 1-2 Androgenic alopecia. Intervention 1: Intervention group: Subcutaneous injection of the solution containing growth factors including fibroblast growth factors, insulin growth factors, and essential amino acids obtained from the human placenta is performed in 15 patients with androgenic alopecia. Placental extract at the rate of 1.5 mg per ml and a total volume of 3 ml per session and 5 times at an interval of 2 weeks is injected into the patients. The placental extract is obtained mechanically in clean room of ViraCellule company, and the necessary quality control tests are performed on the mother and the final sample. Treatment follow-up is done in the first and second weeks and in the second, fourth, and sixth months after the injection. Intervention 2: Control group: Physiological serum is injected in the amount of 3 ml per session and 5 times with an interval of 2 weeks in 15 patients with hair loss. Follow-up is done in the first and second week and in the second, fourth and sixth months after the injection. Yes - There is a plan to make this available What will be shared: Information on the main outcome When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Scientific research Where to obtain: Amir Bajouri bajouri.md@gmail.com How to obtain: The request is sent through the official email of the university, mentioning the recipient's information and the purpose of the request, and after checking the correctness of the information sent, the files are provided to the requester. Comments:
public Amir Bajouri
No 4, Maryam Dead End, South Andarzgo Blvd، Kamraniyeh
Tehran Iran (Islamic Republic of) 1937957511 +98 21 2665 7541 bajouri.md@gmail.com Tehran University of Medical Sciences scientific Maryam Nasimi
Razi Skin Hospital, Razi Alley, Vahdat Eslami St, Hafez St.
Tehran Iran (Islamic Republic of) 1417613151 +98 21 5561 8989 nsm.maryam@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with androgenetic alopecia Age 18 to 50 years Male Norwood-Hamilton grade II to V 18 years 50 years Male Patients with two or more diagnoses of hair loss Treatment of hair loss in the last 3 months Patients undergoing radiotherapy and chemotherapy Immunosuppressive drugs or corticosteroids during the previous 4 weeks Uncontrolled chronic diseases Malignancy Coagulopathy or the use of anticoagulants History of autoimmune diseases HBV, HCV and HIV infections L64 Androgenic alopecia Treatment - Drugs Placebo Intervention group: Subcutaneous injection of the solution containing growth factors including fibroblast growth factors, insulin growth factors, and essential amino acids obtained from the human placenta is performed in 15 patients with androgenic alopecia. Placental extract at the rate of 1.5 mg per ml and a total volume of 3 ml per session and 5 times at an interval of 2 weeks is injected into the patients. The placental extract is obtained mechanically in clean room of ViraCellule company, and the necessary quality control tests are performed on the mother and the final sample. Treatment follow-up is done in the first and second weeks and in the second, fourth, and sixth months after the injection. Control group: Physiological serum is injected in the amount of 3 ml per session and 5 times with an interval of 2 weeks in 15 patients with hair loss. Follow-up is done in the first and second week and in the second, fourth and sixth months after the injection. Side effects. Timepoint: zero and 2 weeks, 1, 2, 4 and 6 months after first injection. Method of measurement: History and clinical examination based on Common Terminology Criteria for Adverse Events criteria. Frontal and vertex hair density. Timepoint: 1, 2, 4, and 6 months after the first injection. Method of measurement: Digital videotrichoscopy. Tehran University of Medical Sciences Approved 2022-10-01 Ethics committee of Medical School, Tehran University of Medical Sciences 1st floor, Faculty of Medicine, Building No. 1, Poursina St., Qods St, Elkhebal St. Tehran Tehran Iran (Islamic Republic of)