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IRCT20230727058942N1 IRCT 2023-12-18 Tehran University of Medical Sciences comparison between masport and dysport in facial botox Comparison of the effects and side effects of Dysport and Masport in patients referred to the ultra-specialized oculoplasty clinic of Farabi Hospital in 1402 2023-08-27 anticipated 160 Complete https://irct.ir/trial/72114 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is performed using a stratified permuted block randomization method with random block lengths (2, 4, 6). After screening, patients will be randomly assigned to groups A and B in a 1:1 ratio to receive Dysport or Masport injections. Stratification variables, including age and gender, will be determined as follows: ARMS (RATIOS: 1:1): * A * B STRATIFY: Yes TOTAL STRATA: 4 STRATIFICATION VARIABLES: 1) Sex: * male * female 2) age: * <40 * >40 For this purpose, a randomization program was written in R software with the help of the center's biostatistician, and the randomization output was produced as an Excel file. Patients, researchers, and site personnel (except pharmacists) are blinded to the type of injectable drug and will remain so until the end of the follow-up period and analysis of the study data, Blinding description: In this study, which is a kind of double-blind study, all participating patients and doctors involved, including the relevant professor who is responsible for the injection and the relevant resident who is responsible for coordinating and writing articles and theses, as well as the nurse related to The design is all kept blind during the design and it is an injectable drug type (Mesport or Dysport brand) do not know. Injection vials are prepared in completely identical and similar syringes by the relevant person and brought to the hospital. 3 Investigating the therapeutic effects of two drugs, MASPORT and DYSPORT, on wrinkles around the eyes. forehead. Intervention 1: Intervention group: Intervention group 1: under MASPORT injection. Each person is injected with 110 units of medicine that contains the chemical composition of botulinum toxin and is manufactured by Masoun Daru pharmaceutical company with the permission of the Ministry of Health in Iran. 500 vials of this medicine are diluted with 2.6 cc of distilled water and placed in an anonymous and unmarked vial for the validity of randomization, and in each person, 50 units of the forehead area, 30 units of the frown line, and 30 units of the wrinkles around the eyes are injected with a syringe. In this study, 1 injection was performed. Intervention 2: Control group: intervention group 2: they are subjected to DYSPORT injection. Each person is injected with 110 units of medicine that contains the chemical composition of botulinum toxin and is available in the country under the brand name DYSPORT with the official license of the Ministry of Health as an import made in Italy or France. 500 vials of this medicine are diluted with 2.6 cc of distilled water and placed in an anonymous and unspecified vial for the validity of randomization, and 50 units of the forehead area, 30 units of the frown line, and 30 units of the wrinkles around the eyes are injected with an insulin syringe. In this study, 1 injection was performed. 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 There is no further information
public Ghazal ghochani
Farabi Ophthalmology Hospital, Qazvin Square, Tehran
tehran Iran (Islamic Republic of) 136616351 +98 21 5540 0003 Gghochani@gmail.com Tehran University of Medical Sciences scientific Ghazal Ghochani
Farabi Ophthalmology Hospital, Qazvin Square, Tehran
tehran Iran (Islamic Republic of) 136616351 +98 21 5540 0003 Gghochani@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Physical and mental health The ability to make decisions regarding voluntary participation in the study Permissible age range in study (27-54 years old) Botox injection candidate in the studied areas 27 years 57 years Both History of heavy surgeries and any type of fracture in any part of the face History of stroke and facial paralysis H00-H06 بررسی اختلالات کاسه چشم و پلک ها Treatment - Drugs Treatment - Drugs Intervention group: Intervention group 1: under MASPORT injection. Each person is injected with 110 units of medicine that contains the chemical composition of botulinum toxin and is manufactured by Masoun Daru pharmaceutical company with the permission of the Ministry of Health in Iran. 500 vials of this medicine are diluted with 2.6 cc of distilled water and placed in an anonymous and unmarked vial for the validity of randomization, and in each person, 50 units of the forehead area, 30 units of the frown line, and 30 units of the wrinkles around the eyes are injected with a syringe. In this study, 1 injection was performed. Control group: intervention group 2: they are subjected to DYSPORT injection. Each person is injected with 110 units of medicine that contains the chemical composition of botulinum toxin and is available in the country under the brand name DYSPORT with the official license of the Ministry of Health as an import made in Italy or France. 500 vials of this medicine are diluted with 2.6 cc of distilled water and placed in an anonymous and unspecified vial for the validity of randomization, and 50 units of the forehead area, 30 units of the frown line, and 30 units of the wrinkles around the eyes are injected with an insulin syringe. In this study, 1 injection was performed 1- To investigate the effect of two drugs in the same doses in removing and reducing the depth of wrinkles in patients. Timepoint: At the beginning of the study, the day of injection, 14 days later, 2 months later and 4 months after injection. Method of measurement: A questionnaire prepared and completed by the doctor and the patient and photos taken of the target areas before and after the injection, which examines the function of the frown muscles and forehead muscles. 2- Examining the short-acting and long-acting side effects of both drugs, including inflammation, redness, and drooping of the eyelids. Timepoint: At the beginning of the study, the day of injection, 14 days later, 2 months later and 4 months after injection. Method of measurement: A questionnaire prepared and completed by the doctor and the patient and photos taken of the target areas before and after the injection, which examines the function of the frown muscles and forehead muscles. 3- Checking the shelf life of two drugs. Timepoint: At the beginning of the study, the day of injection, 14 days later, 2 months later and 4 months after injection. Method of measurement: A questionnaire prepared and completed by the doctor and the patient and photos taken of the target areas before and after the injection, which examines the function of the frown muscles and forehead muscles. 4- Checking the need for re-injection and restoration of two drugs at intervals of 2 weeks, 2 months and 4 months. Timepoint: At the beginning of the study, the day of injection, 14 days later, 2 months later and 4 months after injection. Method of measurement: A questionnaire prepared and completed by the doctor and the patient and photos taken of the target areas before and after the injection, which examines the function of the frown muscles and forehead muscles. Masoun Daro Company Approved 2023-07-22 Ethics Committee of Tehran University of Medical Sciences Farabi Ophthalmology Hospital, Qazvin Square, Tehran tehran Tehran Iran (Islamic Republic of)