Evaluation of the effect of micro-needling on perioral wrinkle
Design
single-armed clinical trial, nonblinded, phase 2 on 30 patients
Settings and conduct
This project is done in the dermatology clinic of saint Alzahra hospital of Isfahan. Micro-needling is done on perioral wrinkles. Patients are treated with 3 sessions of micro-needling 2 weeks apart, wrinkles around the mouth are photographed before the start of treatment, 6 weeks later and 3 months after the last session, photography is done with the same condition at a distance of 30 cm.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Females over the age of 40
Skin types 1, 2 and 3
Exclusion criteria:
Sensitivity to metal
The presence of coagulation disease or the use of anticoagulants
Dermatitis or infection of the study area
Use of Botox during the last 6 months
Using other methods of removing wrinkles in the last 3 months
Scarring and skin disease in the study area
Tobacco use
Intervention groups
Patients are treated with 3 sessions of micro-needling 2 weeks apart, wrinkles around the mouth are photographed before the start of treatment, 6 weeks later and 3 months after the last session, photography is done with the same condition at a distance of 30 cm.
Main outcome variables
The degree of improvement of wrinkles from the patient's point of view; The degree of improvement of wrinkles from the expert's point of view
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211028052900N1
Registration date:2022-01-01, 1400/10/11
Registration timing:registered_while_recruiting
Last update:2022-01-01, 1400/10/11
Update count:0
Registration date
2022-01-01, 1400/10/11
Registrant information
Name
Maryam Fatahinasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3626 3176
Email address
rezamdmr70@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of micro-needling on perioral wrinkles
Public title
Evaluation of effect of micro-needling on perioral wrinkles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Females older than 40years old
Skin types of 1,2 and 3
Exclusion criteria:
Existing scar or other dermatologic disease in perioral area
tobacco use
Using other methods of perioral wrinkle elimination in past 3 months
Botox injection in past 6 months
Sensitivity to metal
The presence of coagulation diorder or the use of anticoagulants
Age
From 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
No. 43, rsashtchi alley, mohtasham kashani ave.
City
Isfahan
Province
Isfehan
Postal code
8175915438
Approval date
2021-11-28, 1400/09/07
Ethics committee reference number
ir.mui.med.rec.1400.438
Health conditions studied
1
Description of health condition studied
perioral wrinkle
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The degree of improvement of wrinkles from the patient's point of view
Timepoint
prior to intervention, 6 weeks later and 3 month after last session
Method of measurement
Visual Analogue Scale
2
Description
The degree of improvement of wrinkles from the expert's point of view
Timepoint
prior to intervention, 6 weeks later and 3 month after last session
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 3 sessions of microneedling 2 weeks apart, digital camera photography (canon power shot S95), inopen microneedling device made in USA and needle depth between 1.5 to 2 mm
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Maryam Fattahinasab
Street address
Soffe blvd.
City
Isfahan
Province
Isfehan
Postal code
81746 75731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansoor Siavash
Street address
Hezar harib Ave
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 5149
Email
research@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
Maryam Fattahinasab
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 43. Rashtchi alley, mohtasham kashani Ave
City
Isfahan
Province
Isfehan
Postal code
8175915483
Phone
+98 31 3626 3176
Email
rezamdmr70@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Fattahinasab
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 43, rashtchi alley, mohtasham kashani ve
City
Isfahan
Province
Isfehan
Postal code
8175915483
Phone
+98 31 3626 3176
Email
rezamdmr70@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Fattahinasab
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 43, rashtchi alley, mohtasham kashani Ave
City
Isfahan
Province
Isfehan
Postal code
8175915438
Phone
0098031036263176
Email
rezamdmr70@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be published after being unidentifiable.
When the data will become available and for how long
Start access 1 month after publishing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of data in scientific studies and review studies can be used by mentioning the source.
Statistical analysis is permitted with the prior permission of researchers.
From where data/document is obtainable
To use the documents and get permission, call rezamdmr70@yahoo.com or phone number 0989396845002.
Dr. Maryam Fattahi Nasab
Isfahan Al-Zahra Hospital Dermatology Clinic
What processes are involved for a request to access data/document
After sending an email or making a call, the unidentifiable documents will be sent to the requesting person by email with in a month.