Comparison of fat injection and fat with stromal vascular fraction injection in the treatment of nasolabial and cheek wrinkles
Design
Clinical trial with control group, with factorial design, one side blinded, randomized, phase 3 on 20 patients. Even and odd numbers used for randomization.
Settings and conduct
20 patients referred to the outpatient clinic of Sinai hospital with medium to deep nasolabial and cheek wrinkles will be randomly selected and randomly divided into two groups of 15 patients. One group will be with fat injections and the other group will be injected with svf and fat injections obtained from the patient. After the injection, the patient will be monitored for 3, 6 and 12 months for the severity of wrinkles, complications (any reaction at the injection site, erythema, bruising, papules, nodules, etc.) and the stability of the effects of the injection. .
Participants/Inclusion and exclusion criteria
Age older than 65 years old; patient satisfaction, and moderate to deep nasolabial wrinkles. Exclusion criteria: diabetes; allergy to svf; hematologic and coagulation problems; smoking; pregnancy; aspirin use; and immune system defects.
Intervention groups
Patients receive 5 ml of pure fat and 5 ml of svf using needle number 27 within 7 minutes. Control group: patients receive 5 ml of pure fat using needle number 27 within 7 minutes.
Main outcome variables
The severity of nasolabial and cheek wrinkles
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140705018373N4
Registration date:2020-08-19, 1399/05/29
Registration timing:prospective
Last update:2020-08-19, 1399/05/29
Update count:0
Registration date
2020-08-19, 1399/05/29
Registrant information
Name
Mohamad Reza Ranjkesh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 116 5061
Email address
ranjkeshm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-05, 1399/04/15
Expected recruitment end date
2020-09-05, 1399/06/15
Actual recruitment start date
2020-09-05, 1399/06/15
Actual recruitment end date
2020-11-05, 1399/08/15
Trial completion date
2020-12-05, 1399/09/15
Scientific title
Comparison of fat injection with and without stromal vascular fraction in the treatment of nasolabial and cheek wrinkles
Public title
Effect of fat injection with and without SVF in the treatment of facial wrinklesAcronymemptyStudy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age under 65 years old
Patients satisfaction
Middle to deep nasolabial wrinkles
Exclusion criteria:
Diabetes melitus
Patients with hematologic and coagulation problems
Smoking
Pregnancy
Use of Aspirin
Patients with defective immune system
Age
To 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using the patient file number and using even and odd numbers. The criterion will be the last digit of the patient's file number and the number zero will be considered even. Evens will be considered as a study group and odd numbers as a control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be blinded for the type of solution injected.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Sina hospital, between Hafez and Shahid-Montazeri square, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Approval date
2020-07-05, 1399/04/15
Ethics committee reference number
TBZMED.REC.1399.218
Health conditions studied
1
Description of health condition studied
Nasolabial and cheek wrinkles
ICD-10 code
Other and
ICD-10 code description
R23.8
Primary outcomes
1
Description
Nasolabial and cheek wrinkle severity
Timepoint
Before injection, 3, 6 and 12 months after injection
Method of measurement
Wrinkle Severity Rating Scale
Secondary outcomes
1
Description
The degree of tissue healing and homogeneity of facial skin
Timepoint
Before injection, 3, 6 and 12 months after injection
Method of measurement
Skin Homogeneity and Texture ScaleI
Intervention groups
1
Description
Intervention group: Patients receive 5 ml of pure fat and 5 ml of svf (stromal vascular fraction) using needle number 27 within 7 minutes.
Category
Treatment - Drugs
2
Description
Control group: Patients receive 10 ml of pure fat using needle number 27 within 7 minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr. Mohammadreza Ranjkesh
Street address
Sina hospital, Azadi Ave., Tabriz town, East Azarbyjan
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8236
Email
ranjkeshm@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ata Mahmoudpour
Street address
Vice chancellor for Research ,Faculty of Medicine, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3385 1117
Email
amahmoodpoor@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz 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
Sponsor: country of origin
Country of origin
IR
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Leila Asadi
Position
Dermatology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Sina hospital, between Hafez and Shahid-Montazeri square, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8236
Email
Leilaasadi463@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Ranjkesh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina hospital, Azadi Ave., Tabriz town, East Azarbyjan
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8236
Email
ranjkeshm@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Ranjkesh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina hospital, Azadi Ave., Tabriz town, East Azarbyjan
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8236
Email
ranjkeshm@tbzmed.ac.ir
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
There is a plan to make this avalable
When the data will become available and for how long
Study data is categorized and coded with no identifiable individuals.
When the data will become available and for how long
To whom data/document is available
Access to study data after publication of the result is available in the journal.
To whom data/document is available
Under which criteria data/document could be used
Anyone interested in using the data can access the study data.
Under which criteria data/document could be used
From where data/document is obtainable
Study data can be used for comparison with other results.
From where data/document is obtainable
What processes are involved for a request to access data/document
Refer to the study's scientific or public accountability person for data.
Comments
The use request will be emailed to the scientific or public accountability person.