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Investigating the Safety and Efficacy of Human Umbilical Cord Blood Serum (HUCBS) Microneedle compared to only Microneedling for Acne Scar treatment (clinical trial phase ۱)

Protocol summary

Study aim
Determining the safety and Efficacy of Human Umbilical Cord Blood Serum (HUCBS) Microneedle compared to only Microneedling for Rolling Acne Scar treatment
Design
This phase 1 clinical trial study is conducted in the form of simple randomization and double-blind, on 30 patients in 3 groups.
Settings and conduct
Microneedling on one side of the face and microneedling with human cord blood serum on the other side of the face, Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with rolling acne scars with different severity (according to the Goodman grading system). Age 18 years and above and less than 50 years. Complete consent of the patient to participate in the project ; Exclusion criteria: active inflammatory acne, active herpes labialis, local infections in the treatment area, pregnancy, breastfeeding, Using peels 4 weeks before treatment, Positive history of bleeding or platelet disorder, positive history of major surgery in the last 6 months, presence of any acute facial infection such as herpes, folliculitis, HIV patients, HBsAg or any chronic disease
Intervention groups
Patients are divided into three groups: for the first group, MN alone is applied on one side of the face and MN + HUCBS on the other side with a 2% dose of microneedling. For the second group, on one side of the face, MN alone and on the other side, MN + HUCBS with a dose of 5% are microneeled. For the third group, on one side of the face, MN alone and on the other side, MN + HUCBS with a dose of 10% are microneeled.
Main outcome variables
Spot and pore and skin collagen, skin elasticity and plasticity, skin thickness and density, recovery time, patient satisfaction, treatment side effects, recovery rate, skin erythema and melanin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221130056672N7
Registration date: 2024-03-10, 1402/12/20
Registration timing: prospective

Last update: 2024-03-10, 1402/12/20
Update count: 0
Registration date
2024-03-10, 1402/12/20
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
2024-04-20, 1403/02/01
Expected recruitment end date
2024-06-20, 1403/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Safety and Efficacy of Human Umbilical Cord Blood Serum (HUCBS) Microneedle compared to only Microneedling for Acne Scar treatment (clinical trial phase ۱)
Public title
Investigating the Safety and Efficacy of Human Umbilical Cord Blood Serum (HUCBS) Microneedle compared to only Microneedling for Acne Scar treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with rolling acne scars with different severity (according to the Goodman grading system) Complete consent of the patient to participate in the plan Age 18 years and above and less than 50 years.
Exclusion criteria:
Being positive in terms of the following: active inflammatory acne, active herpes labialis, local infections in the treatment area, prone to keloids, malignancy, pregnancy, breastfeeding, taking drugs that can affect bleeding or clotting mechanisms, immunosuppression, use of local and systemic steroids, systemic diseases), high blood pressure, diabetes, heart, kidney and liver diseases) Using peels 4 weeks before treatment It should not be done in areas where botulinum injection has been done due to the possibility of microneedle toxin release Positive history of bleeding or platelet disorder, positive history of major surgery in the last 6 months, presence of any acute facial infection such as herpes, folliculitis. HIV patients, HBsAg or any chronic disease
Age
From 18 years old to 50 years old
Gender
Both
Phase
1
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 30
More than 1 sample in each individual
Number of samples in each individual: 2
On one side of the face, microneedling is done alone, and on the other side, microneedling is done with human cord blood serum with a defined concentration.
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, physician and evaluating physician will be unaware of the type of treatment until the end of the study. Two syringes containing normal saline and another containing HUCBS, with similar appearance characteristics, are prepared and given to the physician with numbers 1 and 2.
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
13th Floor, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Simai Iran Street, Quds Town (West), Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2024-02-27, 1402/12/08
Ethics committee reference number
IR.TUMS.HORCSCT.REC.1402.061

Health conditions studied

1

Description of health condition studied
Acne Scar
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The improvement rate of the depth of acne scars and the amount of skin spots and pores
Timepoint
Biometric tests will be done on the first day before the treatment and one month after the treatment
Method of measurement
Visioface

2

Description
The thickness and density of the skin
Timepoint
Biometric tests will be done on the first day before the treatment and one month after the treatment
Method of measurement
Sonography

3

Description
Elasticity and plasticity of the skin
Timepoint
Biometric tests will be done on the first day before the treatment and one month after the treatment
Method of measurement
Cutometer

Secondary outcomes

1

Description
Safety and Efficacy
Timepoint
Safety checks are done before and after each treatment
Method of measurement
Patient history and the examination and diagnosis of the attending physician

Intervention groups

1

Description
The first group: three times every three weeks (days 1-21-42) on one side of the face MN alone and on the other side MN + HUCBS with a dose of 2% microneedling
Category
Treatment - Other

2

Description
The second group: three times every three weeks (days 1-21-42) on one side of the face MN alone and on the other side MN + HUCBS with a dose of 5% microneedling
Category
Treatment - Other

3

Description
The third group: three times every three weeks (days 1-21-42) on one side of the face MN alone and on the other side MN + HUCBS with a dose of 10% microneedling
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
Research Vice President of 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
Research Vice President of 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
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 Kamraniye
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 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.
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