Efficacy and safety of non-cross-linked hyaluronic acid containing exosomes derived from fibroblast cells foreskin in rejuvenating the skin around the eyes in humans (clinical trial phase 1 & 2)

The main purpose of the study is specifically to investigate the effect of non-cross-linked hyaluronic acid containing exosomes derived from fibroblast cells foreskin in rejuvenating the skin around the eyes in humans. Evaluating the effectiveness of exosomes derived from foreskin fibroblasts to improve the thickness of the skin around the eyes Determining the optimal dose of exosomes derived from foreskin fibroblasts on increasing the proliferation of human fibroblast cells and the production and secretion of collagen and increasing angiogenesis for collagen synthesis. Safety evaluation of exosomes derived from foreskin fibroblasts for use in humans

This phase 1 and 2 clinical trial study is conducted in the form of simple randomization and double-blind, on 21 patients in 3 groups.

Intradermal injection (5 to 15 mm), 5 entry points, Skin and Stem Cell Research Center, Tehran University of Medical Sciences

Inclusion criteria : The age of these people to enter the study is between 35 and 45 years old. The skin around the eyes (crow's feet area) of patients has lost its original properties and started to wrinkle. Non-entry criteria: Allergy to injections and syringes People who participate in this study should not have used rejuvenation methods such as Botox 4 to 6 months before the start of the study and injections. Hypersensitivity to non-crosslinked hyaluronic acid

Dividing patients into 3 groups: Group a: receiving a dose of 50 μg of exosomes Group b: receiving a dose of 100 μg of exosomes Group c: receiving a dose of 200 μg of exosomes

Treatment complications, recovery rate, recovery time , patient satisfaction, skin collagen level, epidermis and dermis thickness, skin brightness

Using a simple randomization method, patients who visit the skin clinic of Dr. Nilfroshzadeh are divided into 3 groups, so that one envelope is randomly selected for each patient from the number of 21 sealed envelopes. Each envelope contains the letters a, b, or c. Group a patients are treated with a concentration of 50 micrograms, group b with a concentration of 100 micrograms, and group C patients with a concentration of 200 micrograms.

In this study, the participant researcher, physician and evaluating physician will be unaware of the type of treatment until the end of the study.

All data can be shared after de-identifying individuals.

Six months after the publication and printing of the article

Academic researchers and experts

In order to analyze the results of the study outcomes

etaghiabadi@sina.tums.ac.ir

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.