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IRCT20230724058912N1 IRCT 2023-09-02 Islamic Azad University Comparison of side effects caused by injection of Hyaluronic acid dermal fillers of two brands, Restylane and Perfectha, in the under eye area Comparison of side effects (sensitivity and redness, tissue necrosis, accumulation of mass under the skin) caused by injection of Hyaluronic Acid dermal fillers of two brands, Restylane and Perfectha, under the eye area of ​​patients referred for skin rejuvenation. 2023-09-06 anticipated 86 Complete https://irct.ir/trial/71625 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Participants in both groups remain unaware of the treatment method allocation during the study. The patient is informed that there are two types of hyaluronic acid gel brands in a study and they will receive one of them randomly. Patients remain unaware of the name of the treatment method assigned to them. 4 Complications caused by injecting hyaluronic acid dermal fillers in the under eye area. Intervention 1: The first intervention group: the group of 43 people receiving Restylane filler, Restylane filler, which is made of non-animal hyaluronic acid and is produced by a Swedish company in packages of one milliliter volume, in the amount of half to one milliliter depending on the needs of the patients. We inject in the orbital rim using a 32-gauge needle or cannula within twenty minutes. Intervention 2: The second intervention group: the group of 43 people receiving Perfecta filler, Perfecta filler is made of non-animal hyaluronic acid and is produced by a French company in packages of one milliliter volume, half to one milliliter depending on the needs of the patients. We inject the orbital rim using a 32-gauge needle or cannula within twenty minutes. No - There is not a plan to make this available Justification or reason for not sharing IPD is no more information
public Ensie Keshvari
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Tehran Iran (Islamic Republic of) 1968945713 +98 21 8670 5504 tehrani249@yahoo.com Islamic Azad University Iran (Islamic Republic of) Hyaluronic acid injection in the under eye area age between 18 to 70 informed consent 18 years 70 years Both History of bleeding diseases History of eye surgery in the last month T50.995 Adverse effect of other drugs, medicaments and biological substances Treatment - Drugs Treatment - Drugs The first intervention group: the group of 43 people receiving Restylane filler, Restylane filler, which is made of non-animal hyaluronic acid and is produced by a Swedish company in packages of one milliliter volume, in the amount of half to one milliliter depending on the needs of the patients. We inject in the orbital rim using a 32-gauge needle or cannula within twenty minutes. The second intervention group: the group of 43 people receiving Perfecta filler, Perfecta filler is made of non-animal hyaluronic acid and is produced by a French company in packages of one milliliter volume, half to one milliliter depending on the needs of the patients. We inject the orbital rim using a 32-gauge needle or cannula within twenty minutes. Inflammation and redness of the area based on the dermatologist examination. Timepoint: 7 days, one month and two months after hyaluronic acid injection. Method of measurement: The opinion of two dermatologist separately. Mass accumulation under the skin. Timepoint: 7 days, one month and two months after hyaluronic acid injection. Method of measurement: The opinion of two dermatologist separately. Skin necrosis. Timepoint: 7 days, one month and two months after hyaluronic acid injection. Method of measurement: The opinion of two dermatologist separately. Islamic Azad University Approved 2023-04-17 Ethics committee of Islamic Azad University of Medical Sciences Tehran branch of Islamic Azad University of Medical Sciences, Khaghani st, Shariati st Tehran Tehran Iran (Islamic Republic of)