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Comparison of the efficacy, safety and satisfaction of adipose derived stromal vascular fraction cells injection and 665nm low level diode laser hat in the treatment of androgenetic alopecia

Protocol summary

Study aim
Comparison of the efficacy, safety and satisfaction of adipose derived stromal vascular fraction cells injection and 665nm low level diode laser hat in the treatment of androgenetic
Design
This study is performed in phase 1 and 2 on 30 patients with hair loss. In each session, the first group is treated with SVF injection in three sessions with an interval of one month each. The second group is treated with a laser cap three times a week for 10 minutes each time. The third group is treated with SVF injection in three sessions with an interval of one month each, during which they use a laser helmet three times a week for 10 minutes.
Settings and conduct
This project is performed in the Skin and Stem Cell Research Center of Tehran University of Medical Sciences and patients are divided into three groups: treated with SVF injection, laser cap, SVF injection and laser cap.
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.
Intervention groups
Control group 1: Patients are treated with SVF injections in three sessions, one month apart. Control group 2: Patients are treated with laser caps three times a week for 10 minutes each time. Intervention group: Patients treated with SVF injections are placed in three sessions with an interval of one month each, during which they wear a laser helmet three times a week for 10 minutes.
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: IRCT20200127046282N16
Registration date: 2022-05-15, 1401/02/25
Registration timing: prospective

Last update: 2022-05-15, 1401/02/25
Update count: 0
Registration date
2022-05-15, 1401/02/25
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
2022-05-31, 1401/03/10
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 and satisfaction of adipose derived stromal vascular fraction cells injection and 665nm low level diode laser hat in the treatment of androgenetic alopecia
Public title
Comparison of the efficacy of Stromal Vascular Fraction injection and ow level laser 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
1-2
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are divided into three groups. The first group is treated with SVF injection in three sessions with an interval of one month each. The second group is treated with a laser cap three times a week for 10 minutes each time. The third group is treated with SVF injection in three sessions with an interval of one month each, during which they use a laser helmet three times a week for 10 minutes. The data analyzer was considered blind in this study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics in Biomedical Research of Shahid Beheshti University of medical sciences
Street address
Daneshjoo Blvd, Yaman street
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-04-24, 1401/02/04
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.034

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 one 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
One months after the last session
Method of measurement
Satisfaction Questionnaire and visit

3

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

Intervention groups

1

Description
Control group: Each session, patients are treated with injections of 20 million adipose-derived SVF cells in three sessions, one month apart.
Category
Treatment - Other

2

Description
Control group: Patients are treated with 665 nm laser caps three times a week for 10 minutes each time.
Category
Treatment - Other

3

Description
Intervention group: Patients treated with 20 million injections of adipose-derived SVF cells are placed in three sessions with an interval of one month each, during which they wear a laser helmet three times a week for 10 minutes.
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
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
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sadi Banar
Street address
Laser Application in Medical Sciences Research Center, Shohadaye-Tajrish Educational Hospital, Tajrish Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934370
Phone
+98 21 2271 8021
Email
laser.cntr@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Mohammad Ali Nilforoushzadeh
Position
Professor
Latest degree
Specialist
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 2665 7438
Email
Nilforoosh@sina.tums.ac.ir

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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