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

Comparing the effects and side effects of two drugs, Dysport and Masport

A clinical trial with 2 random groups, Masport and Dysport, double-blind, randomized, phase 2 on 160 patients.

This study will be conducted in the oculoplastic clinic of Farabi Hospital in Tehran, Iran. The study will be conducted in a double-blind manner, and none of the doctors and patients will know the type of injected drug. Before and after the injection, the questionnaire is completed by the patients and the relevant doctor. Before and after the injection, the faces of the patients are photographed while laughing, frowning, and indifference. The patients are followed up at intervals of 2 weeks, 2 months, and 4 months after the injection.

1-Physical and mental health of the participants 2- Decision-making power and completely voluntary participation in the study 3- Allowed age range 27-57 4- Confirmation of the need for injection by the doctor and the candidate for Botox injection 5-Candidates for oculoplasties

Patients in two intervention groups are included in the study, 80 people will be injected with masport drug and 80 people will be injected with dysport drug. The study was double-blind and none of the patients and related doctors knew about the type of medicine.

1- Investigating the effect of two drugs in the same doses in removing and reducing the depth of wrinkles in patients 2- Examining the short-acting and long-acting side effects of both drugs, including inflammation, redness, and drooping of the eyelids. 3- Checking the shelf life of two drugs 4- Checking the need for re-injection and restoration of two drugs at intervals of 2 weeks, 2 months and 4 months

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.

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.