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Investigation of the safety and effectiveness of the combined treatment of fractional CO2 laser and exosome derived from adipose tissue mesenchymal stem cells in the treatment of acne scars and skin rejuvenation compared to fractional CO2 laser alone: ​​a randomized, single-blind clinical trial

Protocol summary

Study aim
Investigation of the safety and effectiveness of the combined treatment of fractional CO2 laser and exosome derived from adipose tissue mesenchymal stem cells in the treatment of acne scars and skin rejuvenation compared to fractional CO2 laser alone: ​​a randomized, single-blind clinical trial
Design
A clinical trial with a control group and an intervention group, with parallel groups, randomized, single-blind, phase 1-2 on 16 patients with moderate and mild wrinkles and scars
Settings and conduct
This project is carried out in the Skin and Stem Cell Research Center of Tehran University of Medical Sciences and without the patient's knowledge from the intervention groups, after the laser, exosome is injected on one side of the face and normal saline is injected on the other side in the scar areas.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patient with moderate and severe acne scars, complete patient satisfaction. Exclusion criteria: pregnant or lactating patients, history of cancer, patients with active acne, people with mental disorders, active infection in the face area.
Intervention groups
Intervention group: (one side of the face) after sufficient anesthesia, it is treated with CO2 laser and exosome injection (Zist Sakht Bonyan Pars Company, Sharif University of Technology). This work will be done in three sessions with an interval of one month. Control group: (One side of the face) After sufficient anesthesia, it is treated with CO2 laser and normal saline injection. This work will be done in three sessions with an interval of one month.
Main outcome variables
Scar's surface; side effects; patient's satisfaction, the amount of wrinkles

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200127046282N52
Registration date: 2024-08-15, 1403/05/25
Registration timing: prospective

Last update: 2024-08-15, 1403/05/25
Update count: 0
Registration date
2024-08-15, 1403/05/25
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
2024-08-21, 1403/05/31
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the safety and effectiveness of the combined treatment of fractional CO2 laser and exosome derived from adipose tissue mesenchymal stem cells in the treatment of acne scars and skin rejuvenation compared to fractional CO2 laser alone: ​​a randomized, single-blind clinical trial
Public title
Investigation of fractional CO2 laser and adipose tissue exosome in the treatment of acne scars and skin rejuvenation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A patient with moderate and severe acne scars Complete consent of the patient to participate in the plan.
Exclusion criteria:
malignancy Receiving chemotherapy in the last 5 years Sepsis Smoking Pregnancy or breastfeeding Active wound or infection at the treatment site Receiving any topical or systemic medication in the last 3 months for acne scars
Age
From 18 years old to 45 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
Sample size
Target sample size: 16
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient will not be given information about the grouping.
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
2024-08-12, 1403/05/22
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.205

Health conditions studied

1

Description of health condition studied
Skin aging
ICD-10 code
L90.9
ICD-10 code description
Atrophic disorder of skin

2

Description of health condition studied
Atrophic scar
ICD-10 code
L90.5
ICD-10 code description
Scar conditions and fibrosis of skin

Primary outcomes

1

Description
The amount of wrinkles
Timepoint
Before treatment and six months after the start of treatment
Method of measurement
Visio face

2

Description
Scar size
Timepoint
Before treatment and six months after the start of treatment
Method of measurement
Visio face

Secondary outcomes

1

Description
Inflammation
Timepoint
After each session
Method of measurement
Questionnaire and visit

2

Description
Intensity of pain
Timepoint
Treatment time
Method of measurement
Questionnaire and visit

3

Description
Side effects
Timepoint
One week after treatment
Method of measurement
Questionnaire and visit

4

Description
Patient Satisfaction
Timepoint
Three month after treatment
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: (one side of the face) after sufficient anesthesia, it is treated with CO2 laser and exosome injection (Zist Sakht Bonyan Pars Company, Sharif University of Technology). This work will be done in three sessions with an interval of one month.
Category
Treatment - Other

2

Description
Control group: (One side of the face) After sufficient anesthesia, it is treated with CO2 laser and normal saline injection. This work will be done in three sessions with an interval of one 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
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
Ali Akbari Sari
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.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
sonazarebio@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
nilforoosh@sina.tums.ac.ir

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
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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