To determine the effect of using botulinum toxin A to prevent changes caused by emotional movements of the nostrils in patients who have undergone rhinoplasty.
Design
Clinical trial with control group with parallel groups, without blinding, randomized and phase 3 on 60 patients. The table of random numbers will be used for randomization.
Settings and conduct
This clinical trial study will be conducted in 1402 in Al-Zahra Hospital on patients who have had a history of rhinoplasty, and these patients will be injected with 100 units of botulinum toxin around the muscles of the nasal lobes. Blinding was not done in this study.
Participants/Inclusion and exclusion criteria
This study is carried out on the population of patients who had the inclusion conditions including a history of rhinoplasty and informed consent. Exclusion criteria: psychological disease or history of anticoagulant treatment.
Intervention groups
The intervention performed in the intervention group is the injection of 100 units or 2.5 ml of botulinum toxin A manufactured in MASON pharmacological company to the muscles around the nostrils in one session after rhinoplasty surgery, and no injection is performed in the control group.
Main outcome variables
emotional movements of nostrils
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230418057953N1
Registration date:2023-05-15, 1402/02/25
Registration timing:prospective
Last update:2023-05-15, 1402/02/25
Update count:0
Registration date
2023-05-15, 1402/02/25
Registrant information
Name
Fatemeh Mehrabipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3673 4042
Email address
fatemehmehrabipour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of using botulinum toxin A in emotional movements of the nostrils in patients undergone rhinoplasty.
Public title
botulinum toxin A in emotional movements of the nostrils
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
history of rhinoplasty
age between 18 and 65
informed conset
Exclusion criteria:
history of psychiatric disorders
using anticoagulants
history of same area botox in past 6 months
pregnancy and breastfeeding
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
To generate random numbers, a table of random numbers was used, and the researcher places his finger on a number and then moves up and to the left. Based on the sample size, a number of envelopes with aluminum wrappers, prepared and each of the randomly generated sequences are written on a card and the cards are placed inside the envelopes in order. To maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the envelopes is glued and placed in a box. Then, according to the order of entry of the participants in the study, an envelope is opened and a random sequence is determined. If the number inside the envelope is odd, the patient will be placed in the first group, and if it is even, the patient will be placed in the second group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of school of medicine of Isfahan University of Medical Sciences
Street address
Isfahan, Hazar Jarib Street, Isfahan University of Medical Sciences, Building No. 3, Faculty of Medicine, Ground Floor, Department of Medical Ethics Contact number: 03137928105
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-04-15, 1402/01/26
Ethics committee reference number
IR.MUI.MED.REC.1402.042
Health conditions studied
1
Description of health condition studied
rhinoplasty
ICD-10 code
Z42.8
ICD-10 code description
Encounter for other plastic and reconstructive surgery following medical procedure or healed injury
Primary outcomes
1
Description
emotional movements of nostrils
Timepoint
before the botox injection and 1 week and 1 month after injection
Method of measurement
FACE questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: injection of 100 units equivalent to 2.5 ml of botulinum toxin A manufactured in MASON pharmacological company into the muscles of the nostrils in one session after rhinoplasty. This work is done with the help of a 30 gauge needle in the Depressor septi nasi and Levator labii superior alaeque nasi muscles. the botox manufactured in MASON pharmacological company.
Category
Treatment - Drugs
2
Description
Control group: without injection
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Fateme Mehrabipoor
Street address
Hezar Jarib Ave, Isfahan town
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8134
Email
fatemehmehrabipour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hezar Jerib Avenue, Isfahan, Isfahan province, postal code 8174673461
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Mehrabipour
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Hezar Jarib, Isfahan town
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8134
Email
Fatemehmehrabipour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Mehrabipour
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Hezar jarib, Isfahan town
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8134
Email
fatemehmehrabipour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Mehrabipour
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Hezar Jarib, Isfahan town
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8134
Email
fatemehmehrabipour@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD