IRCT | Short-term evaluation of the efficacy of injection of stromal vascular fraction isolated from adipose cells using enzymatic and mechanical methods in rejuvenating the eye contour: a double-blind randomized clinical trial.

Protocol summary

Study aim: Using a new therapeutic method in the treatment of aging-related changes in the eye area and rejuvenation of the eye area, which is more effective for the patient and costs less than similar methods.
Design: In this study, which is a randomized and double-blind controlled interventional study, 16 male and female volunteer patients are selected for eye contour rejuvenation considering the study's entry and exit criteria.
Settings and conduct: Skin and Stem Cell Research Center
Participants/Inclusion and exclusion criteria: Inclusion criteria: Patients with complaints of age-related changes in the eye area (including dark circles around the eyes, wrinkles around the eyes, changes in consistency and loose post under the eyes) in the age range of 35 to 65 years, who have informed consent to enter the study and the possibility of attending the visit and have follow-up meetings. Exclusion criteria: inflammation or active herpes infection at the procedure site, hemodynamic instability, use of anticoagulants or NSAIDs in the past 48 hours, platelet dysfunction and thrombocytopenia
Intervention groups: 16 male and female volunteer patients are selected for eye area rejuvenation considering the inclusion and exclusion criteria of the study. In all patients and based on the random table of numbers on one side of the eye area of patients undergoing injection with stromal-vascular fraction (svf) which are separated from fat cells by enzymatic method, and the area around the eye on the opposite side is injected with svf, which is mechanically separated from fat cells.
Main outcome variables: Biometrics, doctor's assessment of recovery, patient's assessment of recovery, side effects

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20220808055641N5

Registration date: 2024-05-19, 1403/02/30

Registration timing: registered_while_recruiting

Last update: 2024-05-19, 1403/02/30

Update count: 0
Registration date: 2024-05-19, 1403/02/30

Registrant information: Name

Alireza Jafarzadeh

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 919 890 7445

Email address

alirezajafarzadeh8@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2024-02-19, 1402/11/30
Expected recruitment end date: 2024-09-20, 1403/06/30
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Short-term evaluation of the efficacy of injection of stromal vascular fraction isolated from adipose cells using enzymatic and mechanical methods in rejuvenating the eye contour: a double-blind randomized clinical trial.

Public title: Short-term evaluation of the efficacy of injection of stromal vascular fraction isolated from adipose cells using enzymatic and mechanical methods in rejuvenating the eye contour: a double-blind randomized clinical trial.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Patients with complaints of age-related changes in the eye area (including dark circles around the eyes, wrinkles around the eyes, changes in consistency and laxity of the post under the eyes)

Exclusion criteria:
Age: From 35 years old to 65 years old
Gender: Both

Phase

1-2

Groups that have been masked

Participant
Outcome assessor
Data analyser

Sample size

Target sample size: 16

Randomization (investigator's opinion)

Randomized

Randomization description

All patients and based on the random table of numbers, one side of the eye area of the patients is injected with stromal-vascular fraction (SVF), which is separated from fat cells by an enzymatic method, and the eye area of the opposite side is injected with SVF, which is They are separated from the fat cells by the mechanical method

Blinding (investigator's opinion)

Double blinded

Blinding description

For the purpose of blinding after SVF processing by two enzymatic and mechanical methods, the samples are presented to the doctor and the patient in the same syringe. The patient and the doctor evaluating the clinical response and analyzing the results are not aware of the type of injection performed on each side of the eye area. .

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences

Street address

16 azar

City

Tehran

Province

Tehran

Postal code

143233335
Approval date: 2023-12-04, 1402/09/13
Ethics committee reference number: IR.TUMS.MEDICINE.REC.1402.492

Health conditions studied

1

Description of health condition studied: Darkness of eye counter
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description: Biometery
Timepoint: Before the intervention, one month later and three months later
Method of measurement: Biometric probe

Secondary outcomes

empty

Intervention groups

1

Description: svf injection is performed by enzymatic method in the dark area under the eye on one side.
Category: Treatment - Drugs

2

Description: Intervention group: SVF injection is performed mechanically in the dark area under the eye on one side.
Category: Treatment - Drugs

Recruitment centers

1

Recruitment center: Name of recruitment center

Rasool Akram Hospital

Full name of responsible person

Alireza Jafarzadeh

Street address

Sattarkhan Street

City

Tehran

Province

Tehran

Postal code

55663468

Phone

+98 919 890 7445

Email

Alirezajafarzadeh8@gmail.com

1

Sponsor: Name of organization / entity

Research Assistant of Tehran University of Medical Sciences

Full name of responsible person

Ali Akbari Sari

Street address

16 Azar Street

City

Tehran

Province

Tehran

Postal code

665433568

Phone

+98 919 890 7445

Email

Alirezajafarzadeh8@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Research Assistant of Tehran University of Medical Sciences
Proportion provided by this source: 50
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

Alireza Jafarzadeh

Position

Dermatology Resident

Latest degree

Medical doctor

Other areas of specialty/work

Dermatology

Street address

Niyayesh Street

City

Tehran

Province

Tehran

Postal code

6643367754

Phone

+98 919 890 7445

Email

Alirezajafarzadeh8@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Iran University of Medical Sciences

Full name of responsible person

Alireza Jafarzadeh

Position

Dermatology Resident

Latest degree

Medical doctor

Other areas of specialty/work

Dermatology

Street address

Niyayesh Street

City

Tehran

Province

Tehran

Postal code

۴۴۶۷۸۴۳۵۷

Phone

+98 919 890 7445

Email

Alirezajafarzadeh8@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Iran University of Medical Sciences

Full name of responsible person

Alireza Jafarzadeh

Position

Dermatology Resident

Latest degree

Medical doctor

Other areas of specialty/work

Dermatology

Street address

Niyayesh Street

City

Tehran

Province

Tehran

Postal code

6647884784

Phone

+98 919 890 7445

Email

Alirezajafarzadeh8@gmail.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: After the completion of the study, all patient data will be shared through the article after de-identification.
When the data will become available and for how long: Access to data starts immediately after the publication of the article.
To whom data/document is available: There are no restrictions on people's access to data.
Under which criteria data/document could be used: There is no restriction on the type of data usage.
From where data/document is obtainable: rasool-E-akram hospital, niyayesh Ave, satar khan Blvd, Tehran
What processes are involved for a request to access data/document: After receiving the email from the applicant, the data will be sent within a maximum of 6 months.
Comments

Short-term evaluation of the efficacy of injection of stromal vascular fraction isolated from adipose cells using enzymatic and mechanical methods in rejuvenating the eye contour: a double-blind randomized clinical trial.