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

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

A clinical trial with a control group, with a parallel group, double-blind, Randomized, phase 3 on 24 patients. To randomize from the table Random numbers were used.

This study is conducted in Rasul Akram hospital center in Tehran. The doctor who scores the results of the study and the statistician do not know which treatment group the patient is in. 1. Determining the severity of alopecia based on Ludwig criteria in female pattern or Hamilton criteria in male pattern 2. Imaging: every appointment, patients are photographed with the Vizioface device and trichoscopy of the hair loss areas. 3.Patient global assessment score: which is completed by the patient based on the level of satisfaction with the treatment with the same scale above

Entry criteria: 1- men and women with hereditary hormonal hair loss, 2-over 18 years old and less than 50 years, 3- Hamilton score 2 to 5 in men and Ludwig score 1 to 3 in women, 4- full patient consent to participate in the project. Exclusion criteria : 1- platelet disorders or thrombocytopenia 2- patients receiving anticoagulants, 3- patients with malignancy 4-receiving chemotherapy in the last 5 years 5- women with hormonal disorders or polycystic ovaries.

Treatments will be A and B. Group A will be treated with conditioned medium and the second group will be treated with PRP

Hair count and hair thickness. Standard photographic score by the doctor It is reported. Patient satisfaction score

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

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.