Comparison of the effectiveness of adipose-derived stem cell condition medium (ADSC_CM) combined with microneedling or fractional carbon dioxide laser on acne scar healing
Evaluation the effect of conditioned medium of adipose derived stem cells on healing of scar after fractional Carbon Dioxide(CO2) laser resurfacing or micro needeling
Design
The aim of this study was to evaluate the efficacy and side effects of using CO2 laser with conditioned medium in comparison with microneedling with conditioned medium in 30 patients with acne scars who were enrolled in block randomized method. In each session immediately after laser treatment, one side of the patient's face (intervention group) conditioned media of adipose derived stem cells, and the other side of the face (control group) physiological serum is applied topically on the laser site for one hour. This procedure is repeated 4 times with 4 week intervals.
Settings and conduct
This design is done at the skin and stem cell research center of Tehran university of medical sciences and without the patient's knowledge, after the CO2 laser or microneedling, one side of the face of conditioned media of ADSC and other side for blinding is used of the physiology serum in the scars.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20-60; Developing middle to severe atrophic scars in face region. Exclusion criteria: Pregnancy and breastfeeding; Active infection in face; Using any local drugs on face except sun protection creams in last month
Intervention groups
Intervention group 1: The whole face is treated with CO2 laser. Immediately, on one side of the face, the conditioned media of adipose derived stem cells, and on the other side of the face, physiological serum is applied topically to the scar site. Intervention group 2: The whole face is treated with microneedling. Then, similar to the first intervention group, conditioned medium and physiological serum are used on both sides of the face.
Main outcome variables
scar's surface; side effects; patient's satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001159N33
Registration date:2021-06-01, 1400/03/11
Registration timing:prospective
Last update:2021-06-01, 1400/03/11
Update count:0
Registration date
2021-06-01, 1400/03/11
Registrant information
Name
Mohamad Ali Nilforoushzadeh
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 5158
Email address
sdlrc@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of adipose-derived stem cell condition medium (ADSC_CM) combined with microneedling or fractional carbon dioxide laser on acne scar healing
Public title
Evaluation the effect of conditioned media of adipose drived stem cells on acne scar
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-60
Having middle to severe atrophic scar in face region
Exclusion criteria:
Pregnancy and breastfeeding
History of cancer
Pregnancy, breastfeeding
Patients with active acne
Vascular / muscle collagenous disorders of immunodeficiency or use of immunosuppressive drugs
People with herpes disease are active
People with Mental Disorders
Active infection in the face
Age
From 20 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
A half face will be considered as the control group and one half as an intervention group
Randomization (investigator's opinion)
Randomized
Randomization description
In this method, block randomization is used. Each patient was considered as a block and left and right sides of their face were randomly assigned to two groups using cards with study groups written on them.
Blinding (investigator's opinion)
Single blinded
Blinding description
In each group, both sides of the face will be treated with CO2 laser or microneedling at the patient's scar area, immediately on one side of the face, the conditioned media of adipose derived stem cells and the other side of the face saline solution is used topically on the scar.
Placebo
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
2021-02-14, 1399/11/26
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.1131
Health conditions studied
1
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
Scar size
Timepoint
before and 3month after the intervention
Method of measurement
visioface
2
Description
side effects
Timepoint
One week after session
Method of measurement
Questionnaire and visit
3
Description
Patient Satisfaction
Timepoint
Three and six months after the last treatment session
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One side of the face after being anesthetized, is first treated with Fractional Laser Co2, and then adipose conditioned media of adipose derived stem cells is applied topically to the scars for one hour.This procedure is repeated 4 times with intervals of 4 weeks.
Category
Treatment - Other
2
Description
Intervention group: One side of the face after being anesthetized, is first treated with microneedling, and then adipose conditioned media of adipose derived stem cells is applied topically to the scars for one hour.This procedure is repeated 4 times with intervals of 4 weeks.
Category
Treatment - Other
3
Description
Control group: (Other side of face) After sufficient anesthesia, first treatment with Fractional Laser Co2, and then physiological serum is applied topically to the site of the scars for one hour. This procedure is repeated 4 times with intervals of 4 weeks.:
Category
Treatment - Other
4
Description
Control group: (Other side of face) After sufficient anesthesia, first treatment with microneedling, and then physiological serum is applied topically to the site of the scars for one hour. This procedure is repeated 4 times with intervals of 4 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Maryam nouri
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Email
m.nouri3023@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abbas Ali Karimi
Street address
Tehran University of Medical Sciences, Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
tums_edu@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
Maryam Nouri
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2223 9387
Email
m.nouri3023@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
A Level or less
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
+98 901 588 6740
Phone
+98 21 2223 9387
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
Mona mahmoudbeyk
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cell Developmental Biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Email
mmahmoodbeyk@yahoo.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