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Comparison of therapeutic effect of nanofat injection alone and nanofat with Stromal Vascular Fraction (SVF), Platelet Rich Plasma (PRP) and ND-YAG laser in improving darkening and rejuvenation under the eye

Protocol summary

Study aim
Comparing the therapeutic effects of nanofat injection alone and nanofat with three interventions 1) vascular stromal cells (SVF), 2) platelet-rich plasma (PRP) and 3) ND-YAG laser on under eye dullness and rejuvenation
Design
Clinical trial with one control group and three intervention groups, with parallel groups, one-way blind (outcome assessor), randomized based on random number table, phase 1 on 30 patients with periorbital hyperpigmentation
Settings and conduct
The study site is the Clinic of Skin and Stem Cell Research Center of Tehran University of Medical Sciences. In this study will be subjected to blinding, and the outcome assessor will be unaware of the treatment type. There are three intervention groups and one control group. Two sessions of treatment will be performed with an interval of one month
Participants/Inclusion and exclusion criteria
Inclusion criteria: cases subjected to under eyes' dullness and wrinkles and in need for rejuvenation base on dermatologist's diagnosis, Exclusion criteria: Use of any treatment to eliminate dullness and rejuvenation under the eyes during recent three months, in case of collagen and vascular diseases , taking steroids or anti-immune drugs, pregnancy and lactation.
Intervention groups
Patients are randomly divided into 1 control group and 3 intervention groups. In the control group, 15 patients will be treated with nanoft injection. In the intervention groups, 15 patients are divided into three groups of 5: one group will receive nanofat and SVF injection, one group will receive nanofat and PRP injection, and the other group will receive nanofat and Nd; YAG laser.
Main outcome variables
dullness rate ; Rejuvenation rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200127046282N21
Registration date: 2023-01-22, 1401/11/02
Registration timing: retrospective

Last update: 2023-01-22, 1401/11/02
Update count: 0
Registration date
2023-01-22, 1401/11/02
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
2022-07-06, 1401/04/15
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effect of nanofat injection alone and nanofat with Stromal Vascular Fraction (SVF), Platelet Rich Plasma (PRP) and ND-YAG laser in improving darkening and rejuvenation under the eye
Public title
Effect of nanofat injection alone and combined with SVF, PRP and ND-YAG laser on treatment of periorbital dark circles and rejuvenation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Under eye wrinkles, dark circles and need for rejuvenation based on dermatologist's diagnosis No medical treatment for under eye's dark circles, wrinkles and rejuvenation in recent 2 months Patients' Informed consent Ages under 50 and over 18 years
Exclusion criteria:
Skin lesions and diseases such as skin cancer Wart Skin infection Collagen and vascular diseases Pregnancy and lactation Taking steroids or anti-immune drugs
Age
From 18 years old to 50 years old
Gender
Both
Phase
1
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients and physician will know the type of treatment, but the outcome assessor will not know the patient's type of treatment. Therefore, it will be performed as a single blind study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1937957511
Approval date
2022-03-09, 1400/12/18
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1487

Health conditions studied

1

Description of health condition studied
ِDarkening under the eye
ICD-10 code
L81.9
ICD-10 code description
disorder of pigmentation, unspecified

Primary outcomes

1

Description
Darkness under the eyes
Timepoint
prior to treatment, three and six months after the last treatment session
Method of measurement
VisioFace device

2

Description
under eye rejuvenation
Timepoint
prior to treatment, three and six months after the last treatment session
Method of measurement
Visioface

3

Description
safety of treatment method
Timepoint
in the Injection session and one week after each session
Method of measurement
Questionnaire and clinical observation

Secondary outcomes

1

Description
Pain Intensity
Timepoint
Injection session
Method of measurement
Questionnaire (scoring from 1 to 10) and visual pain questionnaire

2

Description
Patient satisfaction
Timepoint
prior to treatment, three months and six months after the last treatment session
Method of measurement
Standard questionnaires visual analogue scale (VAS)

3

Description
Inflammation
Timepoint
1-5 hours after injection
Method of measurement
In this study,،the inflammation rate around the eyes (with scores of 0 and 1), will be performed by a physician.

Intervention groups

1

Description
1 cc of nanofat with 1 cc of vascular stromal cells (SVF) extracted from adipose tissue will be injected in 2 sessions with an interval of 1 month.
Category
Treatment - Other

2

Description
Second intervention group: 1 cc of nanofat with 1 cc of platelet-rich plasma (PRP) extracted from blood will be injected in 2 sessions with an interval of 1 month.
Category
Treatment - Other

3

Description
Third intervention group: 1 cc of Nanofat after ND-YAG laser is injected in 2 sessions with an interval of 1 month.
Category
Treatment - Other

4

Description
Control group: 1 cc of Nanofat is injected in 2 sessions with an interval of 1 month.
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
‪Masoumeh Roohaninasab
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
rohaninasab.m@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotoohi
Street address
Central University Organization, sixth floor, Vice Chancellor for Research and Technology, corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 8163 3698
Email
vcr@tums.ac.i
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, 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, Tehran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
sonazarebio@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Full name of responsible person
‪Masoumeh Roohaninasab
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
masoomehrohani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Skin and Stem Cell Research Center, 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, Tehran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
sonazarebio@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
Analytic Code
Not applicable
Data Dictionary
Not applicable
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