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IRCT20200127046282N51 IRCT 2024-07-20 Tehran University of Medical Sciences Comparing the safety and effectiveness of plasma rich fibrin (PRF) to plasma rich platelet (PRP) in the treatment of periorbital rejuvenation and hyperpigmentation Comparing the safety and effectiveness of plasma rich fibrin (PRF) to plasma rich platelet (PRP) in the treatment of periorbital rejuvenation and hyperpigmentation: a randomized double-blind clinical trial study 2024-07-20 anticipated 25 Complete https://irct.ir/trial/77343 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the present study, the method of simple randomization will be used. The randomization sequence will be determined by the researchers before the start of the study, and then sampling will begin. We will have two containers. One container will have 25 numbers from 1 to 25, and the second container will have 25 sealed envelopes indicating which side will receive PRP and which side will receive RPF. The randomization process will proceed as follows: first, a number will be randomly selected from the first container, and then an envelope will be randomly selected from the second container and placed in a designed box. The number drawn from the first container will be paired with the treatment protocol from the envelope drawn from the second container. This process will be repeated for all 25 numbers. Thus, the box will contain 25 numbers, each paired with an envelope containing the treatment. In this method, the type of intervention inside each envelope is unknown, which constitutes randomization concealment. This means that which side of the face receives which treatment will not be known until the participant arrives and the envelope is opened. The treatments will be labeled as A and B, and only the study designer will know the specifics of treatments 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 patient do not know which treatment group they are placed in. N/A Dark circles and wrinkles under the eyes. Intervention 1: Intervention group: Patients will receive one cc of PRP and one cc of RPF in the left half of their face in two sessions, one month apart. Intervention 2: Intervention group: Patients receive one cc of RPF in the left half of the face and one cc of PRP in the right half of the face in two sessions, one month apart. 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 Sona Zare
No 4, Maryam Alley, South Kamraniyeh Street
Tehran Iran (Islamic Republic of) 1937957511 +98 21 2665 7438 sonazarebio@gmail.com Skin and Stem cell Research Center of Tehran University of Medical Sciences scientific Mohammad Ali Nilforoushzadeh
No 4, Maryam Alley, South Kamraniyeh Street
Tehran Iran (Islamic Republic of) 1937957511 +98 21 2665 7438 nilforoosh@sina.tums.ac.ir Skin and Stem cell Research Center of Tehran University of Medical Sciences Iran (Islamic Republic of) Age 18-60 Darkness and wrinkles in the lower eyelid area Informed consent 18 years 60 years Both Patients with malignancy Receiving chemotherapy in the past 5 years Patients with sepsis Smoking Pregnancy or breastfeeding Active wound or infection at the treatment site Receiving any topical or systemic medication in the past 3 months for under-eye darkness H02.71 Chloasma of eyelid and periocular area Treatment - Other Treatment - Other Intervention group: Patients will receive one cc of PRP and one cc of RPF in the left half of their face in two sessions, one month apart. Intervention group: Patients receive one cc of RPF in the left half of the face and one cc of PRP in the right half of the face in two sessions, one month apart. Comparing the safety and effectiveness of plasma rich fibrin (PRF) to plasma rich platelet (PRP) in the treatment of periorbital rejuvenation and hyperpigmentation. Timepoint: In the study investigating the safety and efficacy of injecting fibrin-rich plasma (PRF) in treating aging and dark circles under the eyes compared to platelet-rich plasma (PRP), the time points for measuring dark circles and wrinkles are at 0, 3, 4, and 6 months after the start of the intervention. Method of measurement: In the study investigating the safety and efficacy of injecting fibrin-rich plasma (PRF) in treating aging and dark circles under the eyes compared to platelet-rich plasma (PRP), the measurement of outcome variables will be done through patient and physician satisfaction questionnaires, as well as through visioface biometric assessments. Satisfaction rate. Timepoint: Three months after the last meeting. Method of measurement: Comparing the severity of periorbital dark circles, before and after treatment (score from 0 - 10). Tehran University of Medical Sciences Approved 2024-05-01 Research ethics committee of medical school - Tehran University of Medical Sciences Tehran University of Medical Sciences, Keshavarz blvd. Tehran Tehran Iran (Islamic Republic of)