choosing an efficient procedure for rejuvenation of facial skin with minimal side effects
Design
clinical Trial without a control group
Evaluation of facial skin with Visioface , elastometery and cutometery at he first session and then fullface microfat injection
Evaluation of previous parameteres at 1 month and 6 months later
Settings and conduct
research center of skin and stem cell
10 individuals will be chosen and each one will be compared with the baseline situation after 1 month and 6 months
There is no control group.
Participants/Inclusion and exclusion criteria
individuals without a significant systemic disease
individuals without past facial aesthetic procedures in the last 2 years
Intervention groups
Fullface microfat injection
Main outcome variables
improvement in skin thickness ؛ skin elasticity ؛ skin wrinkles and individuals satisfaction of facial skin beauty
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240218061045N1
Registration date:2024-06-09, 1403/03/20
Registration timing:registered_while_recruiting
Last update:2024-06-09, 1403/03/20
Update count:0
Registration date
2024-06-09, 1403/03/20
Registrant information
Name
pourya hoseiny
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 4511
Email address
hoseiny.pourya@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of Microfat injection in facial rejuvenation
Public title
Evaluation of the efficacy of Microfat injection in facial rejuvenation
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals without a history of facial aesthetic procedures in the past 2 years
individuals without a significant systemic disease
Exclusion criteria:
patients without signs of facial photoaging in examination
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
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 Iran university of medical science
Street address
Iran university of medical science., Hemmat highway., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2024-01-29, 1402/11/09
Ethics committee reference number
1402.427.IR.IUMS.FMD.REC
Health conditions studied
1
Description of health condition studied
Skin aging
ICD-10 code
L57
ICD-10 code description
Skin changes due to chronic exposure to nonionizing radiation
Primary outcomes
1
Description
skin thickness
Timepoint
evaluation before procedure and after 1 month and 6 months
Method of measurement
Evaluation with cutometery device and sonography
2
Description
skin elasticity
Timepoint
Evaluation before procedure and 1 month and 6 months later
Method of measurement
cutometery device
3
Description
Individuals satisfaction with facial beauty
Timepoint
Before the procedure and after 1 month and 6 months
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: fullface microfat injection
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Research center of skin and stem cell
Full name of responsible person
Pourya Hoseiny
Street address
No. 13, Khodamorad Ave., Asef Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1988753356
Phone
+98 21 2243 4511
Email
hoseiny.pourya@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Iran university of medical science., Hemmat Highway., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Pourya Hoseiny
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No.13, Khodamorad Ave, Asef Blvd
City
Tehran
Province
Tehran
Postal code
1988753356
Phone
+98 21 2243 4511
Email
hoseiny.pourya@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Pourya Hoseiny
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No.13, Khodamorad Ave., Asef Blvd
City
Tehran
Province
Tehran
Postal code
1988753356
Phone
+98 21 2243 4511
Email
hoseiny.pourya@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Pourya Hoseiny
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No.13, Khodamorad Ave., Asef Blvd
City
Tehran
Province
Tehran
Postal code
1988753356
Phone
+98 21 2243 4511
Email
hoseiny.pourya@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
Complete dat will be published.
When the data will become available and for how long
Complete data will be published with the article.
To whom data/document is available
Researchers in universities
Under which criteria data/document could be used
For complementary researches
From where data/document is obtainable
Pourya Hoseiny
Hoseiny.pourya@yahoo.com
What processes are involved for a request to access data/document