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IRCT20210612051545N4 IRCT 2022-12-05 Tehran University of Medical Sciences Placenta growth factors in the treatment of androgenetic alopecia Clinical trial of safety and effectiveness of subcutaneous injection of placenta Growth factors in the treatment of androgenetic alopecia 2022-12-01 anticipated 30 Complete https://irct.ir/trial/66978 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is simple. For 30 patients, 30 interventions including 15 drugs and 15 placebos are considered and a code is defined for each intervention. Then for each patient based on the table of random numbers, a code that may be drug or placebo is selected. The drug or placebo is sent to the physician in a disguised form and the physician performs the injection based on the assigned code, Blinding description: In this study, patients, researchers, physician, nurse and outcome evaluator are blinded until the end of the study. For this purpose, a code is assigned to the drug or placebo, and based on the table of random numbers, a code is selected and the drug or placebo is sent to the physician in a covered form with a code. The physician administers the injection to the patient. 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 obtained from the human placenta is performed in 15 patients with androgenic alopecia. Placental growth factors at the rate of 1.5 mg per ml, 3 ml per session, and 5 times at an interval of 2 weeks are injected into the patients. The placental growth factors are obtained by mechanically and chemically digestion in clean room of ViraCellule company, and the necessary quality control tests are performed on the mother and the final sample. Treatment follow-ups are 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 Deadend, Southern Kamraniyeh, Sadr Ave.
Tehran Iran (Islamic Republic of) 1937957511 +98 21 2221 2537 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 obtained from the human placenta is performed in 15 patients with androgenic alopecia. Placental growth factors at the rate of 1.5 mg per ml, 3 ml per session, and 5 times at an interval of 2 weeks are injected into the patients. The placental growth factors are obtained by mechanically and chemically digestion in clean room of ViraCellule company, and the necessary quality control tests are performed on the mother and the final sample. Treatment follow-ups are 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: Injection day, 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 2022-10-30 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)