The effectiveness of botulinum toxin in the treatment of acne vulgaris
Design
Clinical trial with a control group, double-blind, randomized, phase 3 on 30 patients. Random Allocation software was used for randomization
Settings and conduct
moderate to severe acne are included in this study, botulinum toxin is injected on one side of their face and normal saline is injected on the other side of their face, and the results of the response to the treatment are checked in month two and month four by photography and mexameter scan.
Injections are performed in the operating room of Razi Hospital
The exact location of the study is Razi Hospital in Tehran
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with moderate to severe acne based on GAGS criteria
They are between 18 and 55 years old
have the possibility to visit regularly
Do not have any contraindications for receiving botulinum toxin
Exclusion criteria: having needle phobia
Having contraindications to Botox injection
Pregnancy and breastfeeding
Intervention groups
Using botulinum toxin on one side of the face and normal saline on the other side of the face
Main outcome variables
The severity of acne on the face
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230529058336N1
Registration date:2023-06-12, 1402/03/22
Registration timing:prospective
Last update:2023-06-12, 1402/03/22
Update count:0
Registration date
2023-06-12, 1402/03/22
Registrant information
Name
Parsa Shiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4441 7432
Email address
parsa.shiri1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-25, 1402/04/04
Expected recruitment end date
2025-06-25, 1404/04/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Efficacy of Botulinum Toxin In The Treatment Of Acne Vulgaris: A Double-Blind Clinical Trial
Public title
Efficacy Of Botulinum Toxin In The Treatment Of Acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with moderate to severe Acne based on global acne grading system criteria
Age between 18 and 55 years old
Exclusion criteria:
Older than 55 years old
Younger than 18 years old
Having a contraindication to receiving Botox
Having needle phobia
Pregnancy and breastfeeding
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Vahdat Eslami Street, Razi Hospital
City
Tehran
Province
Tehran
Postal code
1199663910
Approval date
2023-05-31, 1402/03/10
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.127
Health conditions studied
1
Description of health condition studied
Acne vulgaris
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasi Hospital
Full name of responsible person
Parsa Shiri
Street address
Vahdat Eslami Street, Razi Hospital
City
Tehran
Province
Tehran
Postal code
1199663910
Phone
+98 21 5288 8282
Email
Parsa.Shiri1995@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Safoura Shakoei Nejad
Street address
Vahdat Eslami Street, Razi Hospital
City
Tehran
Province
Tehran
Postal code
1199663910
Phone
+98 21 5288 8282
Email
Rasihospital@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Parsa Shiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No.21,Qureshi Alley,Sardar Jangal st
City
Tehran
Province
Tehran
Postal code
1476664714
Phone
+98 21 4441 7432
Email
Parsa.Shiri1995@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Safoura Shakoei Nejad
Position
Associate Professo
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Vahdat Eslami Street, Razi Hospital
City
Tehran
Province
Tehran
Postal code
1199663910
Phone
009821052888282
Email
Dr.Shakoei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parsa Shiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 21, Qureshi Alley, Sardar Jangal St
City
Tehran
Province
Tehran
Postal code
1476664714
Phone
+98 21 4441 7432
Email
Parsa.Shiri1995@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
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
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available