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Comparison of the efficacy, safety, tolerability and satisfaction of SVF injection in the treatment of androgenetic alopecia

Protocol summary

Study aim
Comparison of the efficacy, safety, tolerability and satisfaction of SVF injection in the treatment of androgenetic alopecia
Design
This phase 1 study is performed on 24 patients with hair loss. In each session, one side is treated with SVF (intervention) injection and the other side is treated with normal saline (control) injection. All patients before the treatment and 2 months after the second visit and photos are taken by digital camera and tricoscan. To determine the extent of improvement and compare the two groups, at the end of the study, photos of patients are examined by two neutral dermatologists. Patients' satisfaction and tolerance are also recorded and the results are compared.
Settings and conduct
This project is performed in the Skin and Stem Cell Research Center of Tehran University of Medical Sciences and without informing the patients, one side receives SVF as an injection and the other group receives normal saline.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men and women with hereditary hormonal hair loss, age 18 years and older and less than 50 years, Hamilton score 2 to 5 in men and Ludwig score 1 to 3 in women, complete patient consent to participate in the project. Exclusion criteria: platelet disorders, thrombocytopenia, patients receiving anticoagulants, patients with malignancy, receiving chemotherapy in the last 5 years, patients with sepsis, smoking, pregnancy, ulcers or active infections at the treatment site, not receiving any topical medication Or systemic medication in the last 3 months, women with hyperprolactinemia, women with hormonal disorders or polycystic ovaries.
Intervention groups
In each session, one side is treated with SVF (intervention) injection and the other side is treated with normal saline (control) injection.
Main outcome variables
The amount of hair loss; side effects; patient's satisfaction; tolerability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200127046282N8
Registration date: 2022-03-28, 1401/01/08
Registration timing: prospective

Last update: 2022-03-28, 1401/01/08
Update count: 0
Registration date
2022-03-28, 1401/01/08
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
2022-04-19, 1401/01/30
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy, safety, tolerability and satisfaction of SVF injection in the treatment of androgenetic alopecia
Public title
Comparison of the efficacy of SVF injection in the treatment of alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
men and women with inherited hormonal hair loss Age 18 years and older and less than 50 years Hamilton scores 2 to 5 in men and Ludwig scores 1 to 3 in women Complete patient consent to participate in the project
Exclusion criteria:
Platelet disorders Thrombocytopenia Patients receiving anticoagulants Patients with malignancy Receiving chemotherapy during the last 5 years Patients with sepsis Being a smoker Pregnancy Active wound or infection at the treatment site Do not receive any topical or systemic medication in the last 3 months Women with hyperprolactinemia Women with hormonal disorders or polycystic ovaries
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients' heads are randomly divided into two groups. One side is treated with SVF injection and the other side is treated with normal saline injection in 3 sessions 1 month apart.
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
2021-09-22, 1400/06/31
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.708

Health conditions studied

1

Description of health condition studied
Hair loss
ICD-10 code
L64.9
ICD-10 code description
Androgenic alopecia, unspecified

Primary outcomes

1

Description
The amount of hair loss
Timepoint
Before treatment and two month after the last session
Method of measurement
Trichoscan

Secondary outcomes

1

Description
side effects
Timepoint
One week after session
Method of measurement
Questionnaire and visit

2

Description
satisfaction
Timepoint
Two months after the last session
Method of measurement
Questionnaire and visit

3

Description
Tolerability
Timepoint
Each session after transplantation
Method of measurement
Questionnaire and visit

Intervention groups

1

Description
Intervention group: One side of the patient's head is treated with SVF injection.
Category
Treatment - Other

2

Description
Control group: One side of the patient's head is treated with normal saline injection.
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
Elham Behrangi
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
elham.behrangi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Skin and Stem Cell Research Center, 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
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Skin and Stem Cell Research Center, 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, 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
Email
sonazarebio@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Full name of responsible person
Elham Behrangi
Position
Associate 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 2665 7438
Email
elham.behrangi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Skin and Stem Cell Research Center, 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
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
Analytic Code
Not applicable
Data Dictionary
Not applicable
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