Investigating the effect of stromal vascular fraction gel (svf+non cross-linked hyaluronic acid)on the periorbital rejuvenation and comparig it with svf injection alone
To compare the efficacy of SVF alone versus SVF combined with hyaluronic acid in periorbital rejuvenation
Design
Randomized, double-blind, phase 2 clinical trial, split-face design on 10 patients. Randomization was performed using the RAND function in Excel
Settings and conduct
The study is conducted at the Dermatology Clinic of Hazrat Fatemeh Specialized Hospital. After obtaining informed consent, adipose tissue is harvested from the abdominal area and SVF is prepared using a mechanical method. In a single session, intradermal injections are performed: 2 cc SVF is injected on one periorbital side, and a mixture of 1 cc SVF with 1 cc hyaluronic acid on the opposite side. Side allocation is randomized. The study is double-blind; both the patient and the outcome assessors are unaware of the treatment assigned to each side.
Participants/Inclusion and exclusion criteria
:
Inclusion criteria: Individuals aged 20 to 65 with signs of periorbital aging.
Exclusion criteria: Active infection, autoimmune diseases, use of immunosuppressants or anticoagulants, pregnancy, and lactation
Intervention groups
Group 1: Injection of 2 cc SVF around the eye.
Group 2: Injection of a combination of 1 cc SVF and 1 cc hyaluronic acid on the opposite side.
Both groups receive active intervention to compare their efficacy.
Main outcome variables
Periorbital skin changes measured by Visioface device; GAIS improvement score by patient and dermatologists; patient satisfaction (Patient Global Assessment Score); physician satisfaction (Physician Global Assessment Score); recording of adverse events including bruising, infection, hypersensitivity, diplopia.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220322054341N3
Registration date:2025-10-22, 1404/07/30
Registration timing:registered_while_recruiting
Last update:2025-10-22, 1404/07/30
Update count:0
Registration date
2025-10-22, 1404/07/30
Registrant information
Name
masoumeh roohaninasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2421
Email address
rohaninasab.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-22, 1404/06/31
Expected recruitment end date
2025-11-21, 1404/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of stromal vascular fraction gel (svf+non cross-linked hyaluronic acid)on the periorbital rejuvenation and comparig it with svf injection alone
Public title
The effect of svf in periorbital rejuvenation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
participants aged 20 to 65 years presenting with age-related periorbital changes (including dark circles, periorbital wrinkles, decreased skin firmness, and under-eye laxity), who provide informed consent and are able to attend follow-up visits, will be included in the study.
Exclusion criteria:
Active inflammation or herpetic infection at the procedure site, collagen vascular diseases, or warts
use of corticosteroids, immunosuppressive, anticoagulant, or antiplatelet medications
platelet function disorders or thrombocytopenia
pregnancy or lactation
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
10
More than 1 sample in each individual
Number of samples in each individual:
2
Complaints of dark circles, fine wrinkles, and laxity of the periorbital skin
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The injection of stromal vascular fraction (SVF), stromal vascular fraction (SVF)and normal saline was done with syringes of the same shape, the contents of which are not known, and the patient does not know which treatment group he is in. Also, the doctor evaluating the results and the statistician are blinded to the treatment group of the patient.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of School of Medicine, Iran University of medical sciences
Street address
School of medicine, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1449614535
Approval date
2025-03-20, 1403/12/30
Ethics committee reference number
IR.IUMS.FMD.REC.1404.003
Health conditions studied
1
Description of health condition studied
periorbital aging/wrinkles/hyperpigmentation
ICD-10 code
L81.4
ICD-10 code description
Other melanin hyperpigmentation
Primary outcomes
1
Description
Pigmentation (color of the lesion)
Timepoint
1 and 3 months after the treatment
Method of measurement
Skin analysis using the VisioFace system/Patient satisfaction (Patient Global Assessment Score/Physician satisfaction (Physician Global Assessment Score
2
Description
wrinkle
Timepoint
1 and 3 months after the treatment
Method of measurement
Skin analysis using the VisioFace system/Patient satisfaction (Patient Global Assessment Score/Physician satisfaction (Physician Global Assessment Score
Secondary outcomes
1
Description
Complications
Timepoint
1 and 3 months after the treatment
Method of measurement
Using a checklist containing treatment complications including pain, erythema and edema
Intervention groups
1
Description
Intervention group: Intervention Group 1: Injection of 2 cc stromal vascular fraction (SVF) cells extracted from abdominal fat into one side of the periocular area. Fat harvesting involves 40 cc abdominal fat aspiration, followed by centrifugation at 1200g for 3 minutes, nanofat separation with physical filters, and a second centrifugation at 2000g for 3 minutes to isolate the SVF layer. Injection is intradermal, at 1 cm intervals, in a single session.
Category
Treatment - Other
2
Description
.Intervention Group 2: Injection of a combination of 1 cc SVF (prepared as above) and 1 cc non-crosslinked hyaluronic acid gel (Luxiva) into the contralateral periocular area. The mixture is injected intradermally at 1 cm intervals, in a single session.Both interventions are randomly assigned to either the left or right side. Patients and evaluators (two dermatologists) are blinded to the type of injection on each side (double-blind
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Fatemeh Hospital
Full name of responsible person
Masoomeh Rohaninasab
Street address
Seyed Jamaleddin Asadabadi Street, 21st Street, Next to Shafagh Park, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
crtfatima@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoomeh Roohaninasab
Street address
Office of Vice President for International Affairs, Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran, IRAN
City
tehran
Province
Tehran
Postal code
Phone
+98 21 86709
Email
intl@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
Masoumeh Roohaninasab
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No., 21st Street, Next to Shafagh Park, Seyed Jamaleddin Asadabadi Street, Tehran, Iran
City
tehran
Province
Tehran
Postal code
143933111
Phone
+98 21 8871 7272
Email
rohaninasab.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoomeh Roohaninasab
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No., 21st Street, Next to Shafagh Park, Seyed Jamaleddin Asadabadi Street, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
rohaninasab.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elahe khoshnoo
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No., 21st Street, Next to Shafagh Park, Seyed Jamaleddin Asadabadi Street, Tehran, Iran
City
TEHRAN
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
elahekhoshnoo@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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