Investigating the effect of SVF gel (Stromal Vascular Fraction (SVF) + non cross-linked hyaluronic acid) on the periorbital rejuvenation and comparing it with SVF injection alone
Investigating the effect of SVF gel (Stromal Vascular Fraction (SVF) + non cross-linked hyaluronic acid) on the periorbital rejuvenation and comparing it with SVF injection alone
Design
Clinical trial with a control group and an intervention group, with parallel groups, single-blind, non-random assignment to intervention and control groups, phase 1, 10 patients with wrinkles around the eyes
Settings and conduct
The intervention site is the Skin and Stem Cell Research Center of Tehran University of Medical Sciences. In the intervention group, patients are treated with SVF Gel, and in the control group, patients are treated with SVF only. Blinding was performed in this study and the patient was not informed of the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 and 65 years, patient must have aging around the eyes. Inclusion criteria: Active infection in the facial area, pregnancy, breastfeeding, history of cancer.
Intervention groups
In the intervention group, patients are injected with 1 cc of SVF and 1 cc of non-cross-linked hyaluronic acid on one side of the eye area in one session, and in the control group, patients are injected with 2 cc of SVF on one side of the eye area in one session.
Main outcome variables
amount of wrinkles
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N59
Registration date:2025-12-01, 1404/09/10
Registration timing:prospective
Last update:2025-12-01, 1404/09/10
Update count:0
Registration date
2025-12-01, 1404/09/10
Registrant information
Name
Sona Zare
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2665 7438
Email address
sonazarebio@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-21, 1404/09/30
Expected recruitment end date
2026-02-19, 1404/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of SVF gel (Stromal Vascular Fraction (SVF) + non cross-linked hyaluronic acid) on the periorbital rejuvenation and comparing it with SVF injection alone
Public title
Review of Stromal Vascular Fraction Gel injections for eye rejuvenation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age from 18 to 65 years
The patient has aging around the eyes.
Exclusion criteria:
Active infection in the facial area
Pregnancy
Breastfeeding
History of cancer
Age
From 18 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient will not know which intervention is in each group, so the study will be single-blind. The syringe packaging for both products will be the same.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Working Group/Ethics Committee in Research Faculty of Medicine - Tehran University of Medical Scienc
Street address
Elkhebal St., Quds St., Porsina St., Faculty of Medicine
City
Tehran
Province
Tehran
Postal code
1461884513
Approval date
2025-04-13, 1404/01/24
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1404.043
Health conditions studied
1
Description of health condition studied
Eye rejuvenation
ICD-10 code
L90.9
ICD-10 code description
Atrophic disorder of skin
Primary outcomes
1
Description
The amount of wrinkles
Timepoint
Before and 3 months after the intervention
Method of measurement
Visio face
Secondary outcomes
1
Description
Satisfaction rate
Timepoint
After completing the intervention
Method of measurement
Comparison of the reduction in wrinkles around the eyes of patients after treatment compared to before by the patient herself (score 0 - 10)(feminine)
2
Description
Inflammation
Timepoint
Half an hour after the end of the intervention
Method of measurement
Visit
3
Description
Intensity of pain
Timepoint
At the time of the intervention
Method of measurement
Questionnaire and visit (Score 0 to 10 for pain level)
Intervention groups
1
Description
Control group: Patients are injected with 2 cc of Stromal Vascular Fraction on one side of the eye area in one session.
Category
Treatment - Other
2
Description
Intervention group: Patients undergo injections of 1 cc of Stromal Vascular Fraction and 1 cc of non-cross-linked hyaluronic acid on one side of the eye area in one session.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
Dr_nilforoush@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Street address
Vice President for Research and Technology, 6th Floor, Central University Organization, corner of Qods Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
141765383761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Sona Zare
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cellular and Molecular biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
dr.sonazare@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
Dr_nilforoush@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Sona Zare
Position
researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cellular and Molecular Biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
dr.sonazare@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
Not applicable
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