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IRCT20221130056672N1 IRCT 2023-06-21 Tehran University of Medical Sciences Safety and Efficacy of Umbilical Cord Blood Serum Derived Extracellular Vesicles versus for Treatment of Androgenic Alopecia Investigating the Safety and Efficacy of Umbilical Cord Blood Serum Derived Extracellular Vesicles versus Autologus Platelet Rich Plasma and Minoxidil for Treatment of Androgenic Alopecia 2023-12-23 anticipated 30 Complete https://irct.ir/trial/70789 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: simple randomization. There is no stratified randomization. Randomization tool: using simple randomization method, patients who refer to Dr. Nilfroosh Zadeh's skin clinic are divided into 3 groups. In this way, out of the 30 sealed envelopes, one envelope is randomly selected for each patient. Inside each envelope is the letter A, B or C. Group A patients will be treated with extra vesicles, group B will be treated with PRP, and group C patients will be treated with minoxidil, Blinding description: In this study, the participant, the researcher, the relevant doctor and nurse, and the evaluating doctor will be unaware of the type of treatment until the end of the study. 1-2 Androgenic Alopecia. The first group was treated with extra vesicles derived from umbilical cord blood serum with a selected concentration, the second group was treated with autologous PRP by injection, and the third group was treated with minoxidil topically.. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identifying individuals. When: Six months after the publication and printing of the article To whom: Academic researchers and experts Conditions: In order to analyze data related to study outcomes Where to obtain: etaghiabadi@sina.tums.ac.ir How to obtain: It can be submitted after review by the Research Council of the Skin and Stem Cell Research Center of Tehran University of Medical Sciences, which usually takes 2 to 3 months. Comments:
public Ehsan Taghiabadi
No. 4, 4th floor, Maryam dead end, South Kamraniye
Tehran Iran (Islamic Republic of) 1937957511 +98 21 2665 7438 etaghiabadi@sina.tums.ac.ir Tehran University of Medical Sciences scientific Ehsan Taghiabadi
No. 4, 4th floor, Maryam dead end, South Kamraniye
Tehran Iran (Islamic Republic of) 1937957511 0098 2 226657438 etaghiabadi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Women and men with hereditary hormonal hair loss Age 18 years and above and less than 50 years The rate of hair loss in patients is Hamilton score 2 to 5 in men and Ludwig score 1 to 3 in women. Complete consent of the patient to participate in the study 18 years 50 years Both L64.9 Androgenic alopecia, unspecified Treatment - Other The first group was treated with extra vesicles derived from umbilical cord blood serum with a selected concentration, the second group was treated with autologous PRP by injection, and the third group was treated with minoxidil topically. The number of hair follicles using the Trichoscan device, the thickness of the hair follicle using the Trichoscan device. Timepoint: Before the start of the intervention, each treatment session is monthly for 4 months and also 6 months after the end of the treatment. Method of measurement: Findings from VISIOFACE and TES-TB (low hair type with X1 lens, hair density and scalp condition with X60Triple lens, hair diameter and PORE condition with KPL X150 lens and hair shaft surface condition with X700 lens. Safety and Efficacy. Timepoint: At the beginning of the intervention, monthly for 4 months, every one month, after 6 months. Method of measurement: Patient's history, examination, hair diameter, number of hair per surface unit, patient's satisfaction level. Tehran University of Medical Sciences Approved 2023-06-19 Ethics Committee of Tehran University of Medical Sciences Deputy Research and Technology Office, 6th Floor, Central Organization of Tehran University of Medical Sciences, Qods St, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)