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IRCT20230529058336N1 IRCT 2023-06-12 Tehran University of Medical Sciences Efficacy Of Botulinum Toxin In The Treatment Of Acne Evaluation of Efficacy of Botulinum Toxin In The Treatment Of Acne Vulgaris: A Double-Blind Clinical Trial 2023-06-25 anticipated 30 Complete https://irct.ir/trial/70441 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned to the group of botox injection on one side of the face and normal saline injection on the opposite side of the face through a double-blind block randomization method. So that each person was considered as a block. Double blocks are made in such a way that AB combination is injected into the right side of the person's face with Botox and normal saline is injected into the left side of the face. To prepare a random list from the table of random numbers to this It is used that a random number is selected at each step. If the selected number is between 0 and 4, AB combination is considered and if the selected number is 5 to 9, BA combination is considered.Therefore, we repeat this process many times until qualified patients enter the study. According to the output related to Random Allocation Software which is reported as below, the meaning of code 0001:AB That is, botox is injected into the right side of the first person's face and normal saline is injected into the left side of the first person's face. In addition, code 0002:BA means normal saline will be injected on the right side of the second person's face and Botox will be injected on the left side of the second person's face. 0001: BA 0002: AB 0003: AB 0004: BA 0005: AB 0006: BA 0007: AB 0008: BA 0009: AB 0010: BA 0011: AB 0012: BA 0013: AB 0014: BA 0015: BA 0016: AB 0017: BA 0018: AB 0019: BA 0020: AB 0021: AB 0022: BA 0023: BA 0024: AB 0025: AB 0026: BA 0027: BA 0028: AB 0029: AB 0030: BA, Blinding description: The patient does not know on which side of the face we want to inject Botox or normal saline. Coding is done by one of the colleagues of the project, and the evaluator and the patient are blind. 3 Acne vulgaris. Intervention group: patients with moderate to severe acne based on the GAGS criteria, which are examined in 6 areas in this system: forehead, right cheek, left cheek, nose, chin and upper body. First, each lesion is given a grade based on its severity: no lesion = 0, comedone = 1, papule = 2, pustule = 3, and nodule = 4. The final score for each location (Local Score) is calculated as follows.Factor × grade, in the end, the global score will be the sum of the local scores. A score of 1 to 18 is mild acne, 19 to 30 is moderate acne, 31 to 38 is severe acne, and more than 39 is very severe acne.Patients' faces are divided into right and left face groups by double-blind randomization method. On the control side, 20 points are selected in one half of the face and a volume of one cc or precisely 0.2 cc of placebo is injected in each point, which is the same as normal saline (12 cheek points, 6 forehead areas and two chin areas are selected) ) and 20 points are selected on their intervention side (the number of areas and their locations are the same as the intervention side) and 20 units of botulinum toxin (Dystone company brand) and 0.2 cc are injected in each point. The injection is done only once. Both sides of the patient's face will be treated with topical clindamycin 2%, which is manufactured by Razi Hospital Pharmacy.Patients are evaluated by the evaluator at the beginning of the visit and at the second and fourth month. No - There is not a plan to make this available Justification or reason for not sharing IPD is The individual information of the disease was confidential and the report was general about the effect of the treatment on all suicide patients Community Verified icon
public Parsa Shiri
No.21,Qureshi Alley,Sardar Jangal st
Tehran Iran (Islamic Republic of) 1476664714 +98 21 4441 7432 Parsa.Shiri1995@gmail.com Tehran University of Medical Sciences scientific Safoura Shakoei Nejad
Vahdat Eslami Street, Razi Hospital
Tehran Iran (Islamic Republic of) 1199663910 009821052888282 Dr.Shakoei@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with moderate to severe Acne based on global acne grading system criteria Age between 18 and 55 years old 18 years 55 years Both Older than 55 years old Younger than 18 years old Having a contraindication to receiving Botox Having needle phobia Pregnancy and breastfeeding L70.0 Acne vulgaris Treatment - Drugs Intervention group: patients with moderate to severe acne based on the GAGS criteria, which are examined in 6 areas in this system: forehead, right cheek, left cheek, nose, chin and upper body. First, each lesion is given a grade based on its severity: no lesion = 0, comedone = 1, papule = 2, pustule = 3, and nodule = 4. The final score for each location (Local Score) is calculated as follows.Factor × grade, in the end, the global score will be the sum of the local scores. A score of 1 to 18 is mild acne, 19 to 30 is moderate acne, 31 to 38 is severe acne, and more than 39 is very severe acne.Patients' faces are divided into right and left face groups by double-blind randomization method. On the control side, 20 points are selected in one half of the face and a volume of one cc or precisely 0.2 cc of placebo is injected in each point, which is the same as normal saline (12 cheek points, 6 forehead areas and two chin areas are selected) ) and 20 points are selected on their intervention side (the number of areas and their locations are the same as the intervention side) and 20 units of botulinum toxin (Dystone company brand) and 0.2 cc are injected in each point. The injection is done only once. Both sides of the patient's face will be treated with topical clindamycin 2%, which is manufactured by Razi Hospital Pharmacy.Patients are evaluated by the evaluator at the beginning of the visit and at the second and fourth month The number of active papules and pustules and comedones. Timepoint: The effect of botulinum toxin in the treatment of acne vulgaris is investigated in the follow-up of patients at the beginning of the study and at month two and month four. Method of measurement: Mexameter and photography device. Tehran University of Medical Sciences Approved 2023-05-31 Ethics Committee of Tehran University of Medical Sciences Vahdat Eslami Street, Razi Hospital Tehran Tehran Iran (Islamic Republic of)