Characterization and evaluation of the effectiveness of CO2 laser along with human umbilical cord blood serum alginate hydrogel compared to CO2 laser alone in facial skin rejuvenation (Phase I clinical trial)
Characterization and evaluation of the effectiveness of CO2 laser along with human umbilical cord blood serum alginate hydrogel compared to CO2 laser alone in facial skin rejuvenation
Design
Clinical trial with a control group and an intervention group, unblinded, randomized, phase 1 on 20 patients. A simple randomization method was used for randomization.
Settings and conduct
In the clinic of the Skin and Stem Cell Research Center, a layer of cord blood serum alginate hydrogel is placed on the skin of the intervention group and a layer of mimosa repair cream is placed on the skin of the control group, and qualified patients will use it twice a day for two weeks. (The skin should always be moist). Upon arrival of the patient and on the 7th, 14th and 90th days after the laser, the parameters and variables of the biometric test are checked and recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men and women aged 30 to 50 years with skin type II to IV who have been referred for rejuvenation of the eye area and have not had cosmetic intervention on the face such as Botox, dermabrasion, chemical peeling and face lift in the last 6 months. Exclusion criteria: People who have received oral isotretinoin in the last 6 months and have a history of keloids.
Intervention groups
People are divided into two groups of 10 people, the intervention group is treated with umbilical cord blood serum alginate hydrogel and the control group is treated with mimosa repair cream.
Main outcome variables
Repair speed; amount of humidity; the amount of collagen; Inflammation and redness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221130056672N8
Registration date:2024-04-08, 1403/01/20
Registration timing:prospective
Last update:2024-04-08, 1403/01/20
Update count:0
Registration date
2024-04-08, 1403/01/20
Registrant information
Name
EHSAN Taghiabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2665 7541
Email address
etaghiabadi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
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
Characterization and evaluation of the effectiveness of CO2 laser along with human umbilical cord blood serum alginate hydrogel compared to CO2 laser alone in facial skin rejuvenation (Phase I clinical trial)
Public title
Characterization and evaluation of the effectiveness of CO2 laser along with human umbilical cord blood serum alginate hydrogel compared to CO2 laser alone in facial skin rejuvenation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women aged 30 to 50 with skin type II to IV who have referred for facial skin rejuvenation in the eye area.
People who have not had cosmetic intervention on their face such as botox, dermabrasion, chemical peeling and face lift in the last 6 months.
Exclusion criteria:
People who have received oral isotretinoin in the past 6 months and have a history of keloids.
Age
From 30 years old to 50 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Using a simple randomization method, people who have visited the clinic of the research center for facial skin rejuvenation in the eye area will be divided into 2 groups of 10 people in such a way that out of the 20 sealed envelopes, one envelope will be sent to each person. The face is chosen randomly. The letters A and B are inserted inside each envelope. Group A patients will be treated with mimosa repair cream and group B will be treated with umbilical cord blood serum alginate hydrogel.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Research Institute for Oncology, Hematology and Cell Therapy - Tehran
Street address
Shariati Hospital, North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2024-03-09, 1402/12/19
Ethics committee reference number
IR.TUMS.HORCSCT.REC.1402.071
Health conditions studied
1
Description of health condition studied
Skin rejuvenation
ICD-10 code
L59.8
ICD-10 code description
Other specified disorders of the skin and subcutaneous tissue related to radiation
Primary outcomes
1
Description
Improving repair
Timepoint
All sessions: days 0, 7, 14 and 90
Method of measurement
Skin imaging with Visioface device
2
Description
Skin moisture level
Timepoint
All sessions: days 0, 7, 14 and 90
Method of measurement
Corneometer device
3
Description
Inflammation and redness
Timepoint
All sessions: days 0, 7, 14 and 90
Method of measurement
Colorimeter and Mexameter Devices
4
Description
The amount of skin collagen
Timepoint
Before the CO2 laser, one month and three months later
Method of measurement
Cutometer device
Secondary outcomes
1
Description
The amount of pain
Timepoint
Days 0, 7, 14 and 90
Method of measurement
Questionnaire survey (Patient self-report)
Intervention groups
1
Description
Intervention group:A layer of cord blood serum alginate hydrogel is placed on the skin and qualified patients will use it twice a day for two weeks (so that the skin should always be kept moist).
Category
Treatment - Other
2
Description
Control group: A layer of mimosa repair cream is placed on the skin and eligible patients will use it twice a day for two weeks (the skin should always be kept moist).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Street address
No 4 Maryam Dead End South Kamraniyeh, Andarzgo Blvd, Tehran Province, Tehran.
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7541
Email
etaghiabadi@sina.tums.ac.ir
Web page address
https://skinstemcell.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilfroushzadeh
Street address
Research and Technology Deputy, 6th floor , Quds St, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
etaghiabadi@sina.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
2
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Research and Technology Deputy, 6th floor , Quds St, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
etaghiabadi@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran University Of Medical Sciences
Proportion provided by this source
1
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
Ehsan Taghiabadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
No. 4 , 4th floor, Maryam dead end, South Kamraniyeh
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
etaghiabadi@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Taghiabadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
No. 4 , 4th floor, Maryam dead end, South Kamraniyeh
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
etaghiabadi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Taghiabadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
No. 4 , 4th floor, Maryam dead end, South Kamraniyeh
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
etaghiabadi@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after de-identifying individuals.
When the data will become available and for how long
Six months after the publication and printing of the article
To whom data/document is available
Academic researchers and experts
Under which criteria data/document could be used
In order to analyze data related to study outcomes
From where data/document is obtainable
etaghiabadi@sina.tums.ac.ir
What processes are involved for a request to access data/document
It can be submitted after review by the Research Council of the Skin and Stem Cell Research Center of Tehran University of Medical Sciences, which usually takes 2 to 3 months.