Comparison the effect of intradermal injections of botulinum toxin and normal saline in the treatment of enlarged facial pores
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 33 patients, a random number table is used for randomization.
Settings and conduct
This study will be performed from April 1400 to July 1400 in Ahvaz Imam Khomeini Hospital affiliated to Ahvaz University of Medical Sciences.The study includes patients who refer to the dermatology clinic of Imam Khomeini Hospital in Ahvaz for treatment of large facial skin pores and are willing to cooperate and meet the inclusion criteria.
Mark 10 points on each side of the species in a distance of 1 cm. Dilute each vial of 500 units of Masport (Masun Daroo-Alborz, Iran) with 10 ml of normal saline and inject 0.05 ml (2.5 units of Masport) intradermally with a 30G insulin syringe (AVA, Iran) in one cheek ( Randomly) and in the opposite site, mark 10 points in distance of 1 cm and 0.05 ml of normal saline will inject. The patient and the therapist are blinded and will not know how to assign the type of treatment to the left and right cheeks.
Participants/Inclusion and exclusion criteria
Inclusion condition: People with large facial skin pores
No entry conditions:
Pregnant women and breastfeeding mothers
Age under 15 years
Active disease or infection on face skin
Use of laser, retinoids , hydroquinone, microneedling and other methods of large pore treatment
History of Botox allergy
Neurological diseases
Intervention groups
Intradermal injection of Botox and normal saline in the left and right cheeks with random selection for people who complain about large facial skin pores.
Main outcome variables
Reduce the diameter of facial pores, Reduce facial skin oil, reduce facial skin redness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210321050754N1
Registration date:2021-04-19, 1400/01/30
Registration timing:registered_while_recruiting
Last update:2021-04-19, 1400/01/30
Update count:0
Registration date
2021-04-19, 1400/01/30
Registrant information
Name
Saeed Ashoori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3392 2879
Email address
saeed7840@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-07-06, 1400/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of intradermal injections of botulinum toxin and normal saline in the treatment of enlarged facial pores
Public title
Comparison of the effect of Botox injection in reducing the size of facial pores
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with large pores
Exclusion criteria:
Pregnant women and breastfeeding mothers
Active disease or infection on face skin
History of Botox allergy
Use of laser, retinoids , hydroquinone, microneedling and other methods of large pore treatment
Neuromuscular diseases
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
33
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize assignment of types of treatment to the left and right of patients' face, we consider two modes of treatment AB (treatment A left and treatment B right) and BA (treatment B left and treatment A right).
So that the nature of treatment A and B will be determined by the official who is not involved in the process of treatment and data analysis. By using random numbers from the table of random numbers, whenever an individual number is observed, AB treatment is assigned to the individual and whenever an even number is observed, BA treatment is considered for the patient. If necessary, this process can be continued until the number of AB and BA treatments is the same. In other words, according to the sample size (33 people) whenever the frequency of one of the two methods reaches 17, for the rest of the patients, another method will be considered.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is a double-blind study.The patient and the therapist will not know how to assign the type of treatment to the left and right cheeks.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
13th floor, Block A ,Treatment and Medical Education ,Headquarters of the Ministry of Health, Iran TV St ,between South Flamek and Zarafshan ,Ghods Town (West), Tehran
City
Tehran
Province
Tehran
Postal code
Approval date
2021-02-09, 1399/11/21
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1399.173
Health conditions studied
1
Description of health condition studied
Large pores of facial skin
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The size of the pores of the facial skin
Timepoint
Initiation of the study (before the intervention), 2 weeks and 3 months after the start of the study
Method of measurement
Using the Optic Coherence topography device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intradermal injection of botulinum toxin in one of the studied species (random selection)
Category
Treatment - Drugs
2
Description
Control group: Intradermal injection of normal saline in another species (random selection)