Evaluation of Effect of Local Injection of Umbilical Cord Blood Derived Serum versus Local Injection of Platelet Rich Plasma in the Treatment of Striae Distensae(A randomized controlled intervention study)
Investigating the effect of local injection of serum derived from umbilical cord blood compared to local injection of autologous platelet-rich plasma (PRP) in the treatment of stretch marks
Design
A clinical trial with a control group, with 3 groups of 10 people, double-blind, randomized, phase 2 on 30 patients. A simple randomization method was used for randomization.
Settings and conduct
One-to-one intradermal injection with a volume of 1ml in the arm area in Skin and Hair Research Center,Tehran University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Age 50-18 years; Full consent of the patient to participate in the project;
Having striae of type alba (with all three grades from mild to severe);
Exclusion criteria:
Inflammatory acne; Active herpes labialis; Infection in the treatment area; keloid; malignancy; Pregnancy; Breastfeeding;
Immunosuppression; Use of local and systemic steroids; Systemic diseases (Such as high blood pressure; Diabetes; Heart disease; Cancer; Kidney and Liver)
Intervention groups
Patients are divided into 3 groups. The first group was treated with cord blood serum with a concentration of 2%, the second group with cord blood serum with a concentration of 5% and the third group with cord blood serum with a concentration of 10%, in groups 1, 2 and 3 patients for 4 sessions with intervals of 2 weeks to The injection is done in the right arm of the areas with stretch marks and the PRP injection is done in the left arm with stretch marks. The injection of each of the study groups will be done in the next dose after 4 weeks if there are no side effects in the first dose.
Main outcome variables
Variable name;
Tested groups;
Type of treatment;
Complications of treatment;
Recovery rate;
recovery time;
sex;
Age;
Patient satisfaction;
The amount of skin collagen;
Thickness of epidermis and dermis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221130056672N2
Registration date:2023-11-25, 1402/09/04
Registration timing:prospective
Last update:2023-11-25, 1402/09/04
Update count:0
Registration date
2023-11-25, 1402/09/04
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
2023-12-22, 1402/10/01
Expected recruitment end date
2024-02-09, 1402/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Effect of Local Injection of Umbilical Cord Blood Derived Serum versus Local Injection of Platelet Rich Plasma in the Treatment of Striae Distensae(A randomized controlled intervention study)
Public title
Effect of Local Injection of Umbilical Cord Blood Derived Serum versus Local Injection of Platelet Rich Plasma in the Treatment of Striae Distensae
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 50 years
Full satisfaction of the participant in the plan
Has striae alba (with all three degrees of mild, moderate, severe)
Exclusion criteria:
Inflammatory acne
Active herpes labialis
Local infections in the treatment area
Prone to keloid
Malignancy
Pregnancy
Breastfeeding
Use of drugs that can affect bleeding or clotting mechanism
Immunosuppression
Use of local and systemic steroids
Disease systemic diseases (such as high blood pressure ,Diabetes ,heart, kidney and liver diseases)
The use of exfoliators 4 weeks before treatment
In places where botulinum injection has been done, should not be done due to the possibility of microneedle toxin release.
Age
From 18 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Using the simple randomization method, the patients who visit Dr. Nilfroshzadeh's skin clinic are divided into 3 groups, so that one envelope is randomly selected for each patient from the number of 30 sealed envelopes. will be Inside each envelope is the letter A, B or C. Group A patients will be treated with cord blood serum with a concentration of 2%, group B will be treated with cord blood serum with a concentration of 5% and group C patients will be treated with cord blood serum with a concentration of 10%.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study,the participant researcher,doctor and evaluating doctor will be unaware of the type of treatment until the end of the study.
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
Deputy Research and Technology Office, 6th Floor , Central Organization of Tehran Universit of Medical Sciences Qods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416613675
Approval date
2023-10-30, 1402/08/08
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.404
Health conditions studied
1
Description of health condition studied
Striae Distensae
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Epidermis and dermis thickness
Timepoint
Before the start of the intervention and two months after the end of the treatment period (Four months after the start of the treatment)
Method of measurement
Skin Scanner
2
Description
The amount of collagen formation
Timepoint
Before the start of the intervention and two months after the end of the treatment period (Four months after the start of the treatment)
Method of measurement
Visoface
Secondary outcomes
1
Description
Safety
Timepoint
At the beginning of the intervention, at each re-visit session and two months after the end of the treatment period (four months after the start of the treatment)
Method of measurement
Patient history
2
Description
Effectiveness
Timepoint
At the beginning of the intervention, at each re-visit session and two months after the end of the treatment period (four months after the start of the treatment)
Method of measurement
Patient satisfaction
Intervention groups
1
Description
Intervention group: Treated Local Injection of Umbilical Cord Blood Derived Serum
Category
Treatment - Other
2
Description
Control group: Treated Local Injection of Platelet Rich Plasma
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 Nilfrooshzadeh
Street address
No.4 Maryam Dead End South Kamraniyeh, Andarzgo Blv, Tehran Province, Tehran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7541
Email
etaghiabadi@sina.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
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
Applied cell sciences
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
ethaghiabadi@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 the results of the 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.