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IRCT20221130056672N5 IRCT 2024-01-29 Research Vice President of Tehran University of Medical Sciences 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 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) 2024-03-25 anticipated 21 Complete https://irct.ir/trial/75122 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: 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, Blinding description: In this study, the participant researcher, physician and evaluating physician will be unaware of the type of treatment until the end of the study. 1-2 skin rejuvenation. Intervention 1: Group a: treated with non-cross-linked hyaluronic acid combination (0.5 cc) along with exosomes derived from fibroblast foreskin at a dose of 50 micrograms. Intervention 2: Group b: Treated with a combination of non-cross-linked hyaluronic acid (0.5 cc) along with exosomes derived from fibroblast foreskin with a dose of 100 micrograms. Intervention 3: Group c: treated with non-cross-linked hyaluronic acid combination (0.5 cc) along with exosomes derived from fibroblast foreskin with a dose of 200 micrograms. Intervention 4: Control group: Treated with 0.5cc of non-cross-linked hyaluronic acid. 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 the results of the 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 Kamraniyeh
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 Kamraniyeh
Tehran Iran (Islamic Republic of) 1937957511 +98 21 2665 7438 ethaghiabadi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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. 35 years 45 years Both 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 Treatment - Other Treatment - Other Treatment - Other Treatment - Other Group a: treated with non-cross-linked hyaluronic acid combination (0.5 cc) along with exosomes derived from fibroblast foreskin at a dose of 50 micrograms Group b: Treated with a combination of non-cross-linked hyaluronic acid (0.5 cc) along with exosomes derived from fibroblast foreskin with a dose of 100 micrograms. Group c: treated with non-cross-linked hyaluronic acid combination (0.5 cc) along with exosomes derived from fibroblast foreskin with a dose of 200 micrograms Control group: Treated with 0.5cc of non-cross-linked hyaluronic acid Rejuvenation of crow's feet skin around the eyes. Timepoint: Changes in the mentioned area are measured 4 weeks, 8 weeks, and 12 weeks after the injection, and 8 weeks after the last injection (20 weeks from the day of injection), final examinations are performed. Method of measurement: 1- Visio face: a full-face photography method for facial skin analysis, optimal product recommendation and treatment documentation. Using this method, before and after the skin and the surface and depth of wrinkles are measured. 2- Colorimeter: The colorimeter contains a photocell that is able to detect the amount of light passing through the investigated solution. As a result, the color is checked before and after the end of the test so that a diagnosis can be made in case of lightening of the skin. 4- Sonography: This test is also used to measure thickness and density. Safety. Timepoint: Checks for safety are done one week after each injection and before the time of re-injection. Method of measurement: Patient history and lack of swelling in the injection area. Research Vice President of Tehran University of Medical Sciences Approved 2023-12-13 research ethics committees of research institute for Oncology, Hematology and cell therapy - Tehran 13th Floor, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Simai Iran Street, Quds Town (West), Tehran Tehran Tehran Iran (Islamic Republic of)