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Evaluation of the effectiveness of stromal vascular fraction cells in the impact of Nanofat on acne scar

Protocol summary

Study aim
Evaluation of the impact of SVF cells in the effectiveness of Nanofat on acne scar healing
Design
This study will be a randomized single-blind clinical trial on 10 patients. Target population is patients with facial acne scars who referred to a dermatology clinic in 1399.
Settings and conduct
In these patients, after preparing SVF and Nanofat by taking 100 ccs of fat from the thigh area, the scars on one side of the face are treated with Nanofat, which is, in fact, the control group, and the scars on the other side are treated with Nanofat and SVF together, which is the intervention group. Post-treatment evaluation of patients three months after the intervention is performed as follows: 1)Evaluation of the change in scar size based on the digital re-imaging 2)Evaluating the extent of Neoclagenesis by ultrasound.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being infected with two to three-grade acne scars Fits Patrick type IV to V Exclusion criteria: Age under 18 years old, being under treatment with anticoagulants or steroids, active skin or systemic infection, malignancy or history of chemotherapy, breastfeeding or pregnancy, history of receiving any analgesic drugs in the last week before the intervention.
Intervention groups
In patients with acne scars, after preparing SVF and Nanofat by taking 100 ccs of fat from the thigh area, the scars on one side of the face are treated with Nanofat, which is, in fact, the control group, and the scars on the other side are treated with Nanofat and SVF together, which is the intervention group.
Main outcome variables
Neoclagenesis, size of the acne scar and scar grade changes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200901048586N1
Registration date: 2021-12-09, 1400/09/18
Registration timing: registered_while_recruiting

Last update: 2021-12-09, 1400/09/18
Update count: 0
Registration date
2021-12-09, 1400/09/18
Registrant information
Name
Sepideh Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2285 2343
Email address
sepideh.moradi1989@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of stromal vascular fraction cells in the impact of Nanofat on acne scar
Public title
Evaluation of the impact of adipose tissue stem cells on the effectiveness of fat particles injection, prepared from patient's adipose tissue, in the treatment of َAcne scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has the informed consent to participate in the study. The patient should be able to participate regularly at all appointments and follow-up sessions. The patient should not have any serious internal disease. The patient should not have accompanying disease on the treatment site.
Exclusion criteria:
Taking anticoagulants and steroids Existence of active skin or systemic infection Having a malignancy or a history of receiving chemotherapy medications Breastfeeding or pregnancy History of receiving any analgesic medications during the week before of the intervention
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 10
More than 1 sample in each individual
Number of samples in each individual: 2
Injection of Nanofat on one side of the face and injection of Nanoft and SVF on the other side of the face
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly blinded clinical trial Nanofat cells are injected into scars on both sides of the face and SVF cells are injected randomly into scars on only one side of the face.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, acne scars on both sides of the face are treated with Nanofat injection. However, SVF injections are performed randomly on only one side, and the patient does not know which side the SVF injection is in.
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran university of Medical Sciences
Street address
Iran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-07-28, 1399/05/07
Ethics committee reference number
IR.IUMS.FMD.REC.1399.291

2

Ethics committee
Name of ethics committee
Ethics committee of Iran university of Medical Sciences
Street address
Iran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-09-26, 1399/07/05
Ethics committee reference number
IR.IUMS.FMD.REC.1399.291

Health conditions studied

1

Description of health condition studied
Acne scar
ICD-10 code
L70
ICD-10 code description
Acne

2

Description of health condition studied
Acne scar
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
In all patients, the initial grade of acne scar is qualitatively determined based on the Goodman and Baron grading system (grade 1 grade 2 grade 3 grade 4).
Timepoint
Acne scar Examination before the intervention is one month and then three months later.
Method of measurement
1) Scar size change evaluation based on digital re-imaging, 2)Evaluating the extent of Neoclagenesis by ultrasound.

Secondary outcomes

empty

Intervention groups

1

Description
Control group: In these patients, after preparing SVF and Nanoft by taking 100 ccs fat from the thigh area, the scars on one side of the face are treated with only Nanofat. However, the scars on the other side are treated with Nanoft and SVF both together. The part of the face that was treated with Nanoft alone is the control group
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasul akram hospital
Full name of responsible person
Sepideh Moradi
Street address
Sattar Khan St., Maziar Mansouri St., Rasoul Akram Hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 9595
Email
sepideh.moradi1989@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dermatology and Stem Cell Research Center of Tehran University of Medical Sciences
Street address
Tehran, Dermatology and Stem Cell Research Center, No .4,Maryam Dead End,South Kamaranieh (Pashazhari) Ave
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 2665 7541
Email
info@skinstemcell.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
Sepideh Moradi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 2, Unit 3, Shahid Jafari Alley, 3rd Dashtestan St., Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1947948584
Phone
+98 21 2284 1683
Email
sepideh.moradi1989@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sepideh moradi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 2, Unit 3, Shahid Jafari Alley, 3rd Dashtestan St., Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1947948584
Phone
+98 21 2284 1683
Email
sepideh.moradi1989@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sepideh Moradi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No. 2, Unit 3, Shahid Jafari Alley, 3rd Dashtestan St., Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1947948584
Phone
+98 21 2284 1683
Email
sepideh.moradi1989@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
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