Investigating the effectiveness of the combination therapy of CO2 fractional laser and conditioned medium derived from foreskin fibroblast cells in the treatment of burn scars compared to CO2 fractional laser alone : Phase 1 clinical trial
Investigating the effectiveness of the combination therapy of CO2 fractional laser and CM hFFs in the treatment of burn scars compared to CO2 fractional laser alone s: Phase 1 clinical trial
Design
This study is performed as a phase 1 clinical trial on 10 patients. After obtaining sufficient anesthesia, the patient's scar treatment areas are treated with fractional CO2 on both sides of the face. Immediately after the laser, one patient scar (intervention group) is injected with CM hFFs, and the other scar (control group) is injected with physiological serum. All patients are photographed with a digital camera before treatment and at each visit. To determine the extent of improvement and compare the two sides, at the end of the study, photos of patients are examined by two neutral dermatologists. Patient satisfaction is also recorded and the results are compare
Settings and conduct
This project is performed in the Skin and Stem Cell Research Center of Tehran University of Medical Sciences, and after the laser, one side of the conditioning medium cells scar is injected and the other side is injected in the areas of the physiological serum scar.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with skin type 1-4, patients with atrophic burn scars in more than one organ from 5 years ago to 3 months ago. Exclusion criteria: Age under 18 years, patients who have received laser treatment in the last three months, patients with active colloidal scar or active skin lesion at the injection site, patients with coagulation and platelet disorders, patients with a history of anticoagulants.
Intervention groups
Patients with fractional CO2 laser with CM hFFs will receive three sessions one month apart. In control group Patients will receive fractional CO2 laser and physiological saline three sessions one month apart.
Main outcome variables
scar's surface; side effects;
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N33
Registration date:2024-05-16, 1403/02/27
Registration timing:prospective
Last update:2024-05-16, 1403/02/27
Update count:0
Registration date
2024-05-16, 1403/02/27
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
2024-05-30, 1403/03/10
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of the combination therapy of CO2 fractional laser and conditioned medium derived from foreskin fibroblast cells in the treatment of burn scars compared to CO2 fractional laser alone : Phase 1 clinical trial
Public title
Investigating the effectiveness of CO2 fractional laser and conditioned medium in the treatment of burn scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with skin type 1-4
Patients with atrophic burn scars in more than one organ from 5 years ago to 3 months ago
Exclusion criteria:
Age under 18 years
Patients who have received laser treatment in the last three months
Patients with active colloidal scar or active skin lesion at the injection site
Patients with coagulation and platelet disorders
Patients with a history of underlying disease such as diabetes and autoimmune connective tissue disease that affect wound healing
Patients with active viral infections
Patients with a history of anticoagulants
History of malignancy or receiving chemotherapy
Pregnancy and lactation
Age
From 18 years old to 50 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer will not be aware of the intervention groups, Therefore, the study will be performed blindly.
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
1417653761
Approval date
2024-05-01, 1403/02/12
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.051
Health conditions studied
1
Description of health condition studied
burn scar
ICD-10 code
L90
ICD-10 code description
Atrophic disorders of skin
Primary outcomes
1
Description
Scar size
Timepoint
before and 6 month after the intervention
Method of measurement
visioface
Secondary outcomes
1
Description
Side effects
Timepoint
One week after treatment
Method of measurement
Questionnaire and visit
2
Description
Patient Satisfaction
Timepoint
six months after treatment
Method of measurement
Questionnaire
Intervention groups
1
Description
Patients with the deka fractional CO2 laser, along with 2 cc of fibroblast cell conditioning medium, will receive three sessions one month apart
Category
Treatment - Other
2
Description
Control group: Patients will receive fractional CO2 laser and physiological saline three sessions one month apart
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, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
Nilforoosh@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
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
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
Fax
Email
sonazarebio@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Position
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 2221 5558
Email
nilforoosh@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
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
Fax
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