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

Evaluatation the safety and efficacy of fibrin-rich plasma (PRF) injections in treating aging and dark circles under the eyes compared to platelet-rich plasma (PRP)

This study is a randomized double-blind clinical trial with a control group, conducted on 25 patients, using the simple randomization method.

25 patients visiting skin research center will be randomly assigned to two groups. In the first group, they will receive PRP on the left side of the face and RPF on the right side in three sessions, one month apart. The second group will receive RPF on the left side of the face and PRP on the right side in three sessions, one month apart. Finally, the results will be compared between the two groups and between the two sides of the face. It will be conducted in a double-blind manner, where the evaluating physician and the statistical expert will be unaware of the treatment groups.

Inclusion criteria: age 18 years and above and under 60 years, having darkness and wrinkles in the lower eyelid area, written informed consent for participation in the study exclusion criteria: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 medication in the past 3 months for under-eye darkness

Patients will be randomly assigned to two groups. In the first group (A), patients will receive autologous PRP on the left side of the face and autologous RPF on the right side in three sessions, one month apart. In the second group (B), patients will receive RPF on the left side of the face and PRP on the right side in three sessions, one month apart.

Periorbital dark circles; patient's satisfaction

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

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.