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Investigation the effect of injection of nanofat for correction of fine facial wrinkles

Protocol summary

Study aim
Determining the effectiveness of injection of nanofat for correction of fine facial wrinkles
Design
This study is a randomized clinical trial, 15 patients who will be referred to dermatology clinic of faghihi hospital will be enrolled randomely. As far as the methodology is concerned, due to lack of similar studies, considering statistician, investigating at least 15 patients would be sufficient. The fat from abdomen will be harvested from these patient abdomen under local anesthesia, the fat will be processed to nanofat and injected intradermally in facial wrinkles. The photo of patients will be taken prior and 7 month after the injection. Volume, depth and area of wrinkles will be measured with visioface 1000D, and data will be analyzed with paired t-test. This study doesnt have control group.
Settings and conduct
This study will be done in dermatology clinic of shiraz faghihi hospital. The fat will be harvested from the patient’s abdomen and processed to nanofat and injected intradermally into the facial wrinkles. Photo will be taken before and 7 month after the procedure and volume, depth and area of the wrinkles will be evaluated by the visioface 1000D. All the patients will sign the informed consent.
Participants/Inclusion and exclusion criteria
Patients between 30-65 years old who will be referred to dermatology clinic of shiraz faghihi hospita, with fine facial wrinkles will be enrolled in this study randomely.Patients should not have history of facial trauma recent filler injection, recent botox injection, co-morbidities, operation for correction of facial wrinkle.
Intervention groups
Patients with fine facial wrinkles in forehead area, the fat will be aspirated from their abdomen in one sesion, processed to nanofat and injected in their wrinkles.
Main outcome variables
Area of facial wrinkles, volume of facial wrinkles, depth of facial wrinkles

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210303050559N1
Registration date: 2022-12-03, 1401/09/12
Registration timing: retrospective

Last update: 2022-12-03, 1401/09/12
Update count: 0
Registration date
2022-12-03, 1401/09/12
Registrant information
Name
farzane akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3639 2561
Email address
farzane.akbarii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-10, 1399/12/20
Expected recruitment end date
2021-03-18, 1399/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of injection of nanofat for correction of fine facial wrinkles
Public title
Nanofat in fine facial wrinkles
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Having fine facial wrinkles in forehead area
Exclusion criteria:
Having history of facial trauma Co-morbidities Botox injection 6 months before and 7 months after procedure Previous operation for facial wrinkles Filler injection for the facial wrinkles
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 15
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 Shiraz University of Medical Sciences
Street address
University of medical science, zand street, shiraz
City
shiraz
Province
Fars
Postal code
7134845794
Approval date
2019-04-22, 1398/02/02
Ethics committee reference number
IR.SUMS.MED.REC.1398.089

Health conditions studied

1

Description of health condition studied
Facial wrinkles
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Depth of facial wrinkles
Timepoint
Before fat injection and 7 month later
Method of measurement
Using a device, visioface 1000D (ck electronic, manufactured in germany)

2

Description
Volume of facial wrinkle
Timepoint
Before fat injection and 7 month later
Method of measurement
Using a device, visioface 1000D (ck electronic, manufactured in germany)

3

Description
Area of facial wrinkle
Timepoint
Before fat injection and 7 month later
Method of measurement
Using a device, visioface 1000D (ck electronic, manufactured in germany)

Secondary outcomes

1

Description
Decreasing the depth of facial wrinkle
Timepoint
Before the fat injection and 7 month later
Method of measurement
Using a device, visioface 1000D ( ck electronic, manufactured in germany)

2

Description
Decreasing the volume of facial wrinkle
Timepoint
Before the fat injection and 7 month later
Method of measurement
Using a device, visioface 1000D ( ck electronic, manufactured in germany)

3

Description
Decreasing the area of facial wrinkle
Timepoint
Before the fat injection and 7 month later
Method of measurement
Using a device, visioface 1000D ( ck electronic, manufactured in germany)

Intervention groups

1

Description
Intervention group: The effect of nano-fat injection in correcting fine facial wrinkles in patients over 40 years old with facial wrinkles referred to the skin department of Faghihi Hospital in Shiraz, any area with excess fat deposits is selected as a donor site. Surface injection of 2% lidocaine is performed with a 27G fine needle at the cannula entry points.Any area with excess fat deposits is selected as a donor site. Surface injection of 2% lidocaine is performed with a 27G fine needle at the cannula entry points. The infiltration cannula is a 3 mm diameter blunt-tipped device with many side openings attached to a 10 or 20 cc syringe. Fat (about 10 cc) after infiltration, mostly from the lower abdomen (or thigh) was removed with about 250 cc of swelling solution containing 1 mg of epinephrine 1:1000, 1000 cc of 0.9% normal saline and 25 ml of 2% lidocaine. will be The harvested fat is filtered through a sterile 0.5 mm pore size filter and then transferred between two 10 cc syringes connected to each other by a female-to-female luer-lok connector. After about 30 passes, the fat turns into an emulsion.At the end of the fragmentation process, the fat is liquefied and easily passes through the sharp needle (27G). The patient's face is anesthetized with topical lidocaine, and the processed fat is injected into the fine wrinkles. Patients are evaluated before, immediately after and 3 months after treatment. In each visit, we take pictures from the front, left and right with Visioface 1000D (Electronic CK, made in Germany). This device has the ability to measure volume, area and depth as three specified parameters of wrinkles that are quantitatively compared before and after treatment. Also, the side effects of fat grafting, such as erythema, edema, ecchymosis, and infection, will be explained to patients.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Faghihi hospital, dermatology clinic
Full name of responsible person
Farzaneh akbari
Street address
Faghihi hospital, zand street, shiraz
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3231 9049
Fax
+98 71 3231 9049
Email
Farzane.akbarii@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Abbas rezaeian zade
Street address
Central office of medical university, zand street, shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
+98 71 3230 5410
Email
Vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh akbari
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Dermatology clinic, Faghihi hospital, zand street, shiraz
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3231 9049
Email
Farzane.akbarii@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzane Akbari
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Dermatology clinic, faghihi hospital, zand street, shiraz
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3231 9049
Email
Farzane.akbarii@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh akbari
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Dermatology clinic, faghihi hospital, zand street, shiraz
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3231 9049
Email
Farzane.akbarii@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
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