Isolation and Comparison the Expression Factors of Frontal and Occipital Hair Follicle Stem Cells in Androgenic Alopecia
Design
Non-randomized and non-blinded phase 3 clinical trial on 15 patients
Settings and conduct
The studied sample is among the patients with androgenetic alopecia referred to the Sinai Medical Training Center in Tabriz, which is a medical training referral center related to medical sciences in the northwest of the country. There is no blinding and randomization in this study.
Participants/Inclusion and exclusion criteria
The criteria for inclusion in the study is alopecia with androgenic distribution based on the clinical criteria of Hamilton grade 3 or 4 classification in men and Ludwick grade 2 in women. Patients with alopecia of chronic disease, history of anemia, thyroiditis, bone tissue diseases, drug and alcohol addiction, and women with confirmed systemic hyperandrogenism will be excluded.
Intervention groups
Intervention group: Hair follicles will be taken simultaneously from the occipital and frontal scalp areas of the patients through the micro punch biopsy method in a sterile operating room after obtaining the consent of the patients. Then the follicles will be prepared for growth in the culture medium. After filling the bottom of the flask with cultured cells, the culture medium will be centrifuged at the appropriate temperature and speed. Finally, it is washed with flowcytometry buffer and secondary antibody is added to it and incubated again, and at the end surface markers will be examined with flowcytometry device.
Main outcome variables
Expression of markers of differentiation or non-differentiation of hair follicle stem cells including CD31, Krt15 and Ig-β1
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140705018373N7
Registration date:2024-04-14, 1403/01/26
Registration timing:retrospective
Last update:2024-04-14, 1403/01/26
Update count:0
Registration date
2024-04-14, 1403/01/26
Registrant information
Name
Mohamad Reza Ranjkesh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 116 5061
Email address
ranjkeshm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-03-15, 1402/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Isolation and Comparison the Expression Factors of Frontal and Occipital Hair Follicle Stem Cells in Androgenic Alopecia
Public title
Isolation and Comparison the Expression Factors of Hair Follicle Stem Cells in Androgenic Alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Alopecia with androgenic distribution based on the clinical criterion of Hamilton grade 3 or 4 in men and Ludwick grade 2 in women
Exclusion criteria:
Alopecia of chronic disease
History of anemia
Thyroiditis
History of connective tissue diseases
Drug and alcohol addiction
Women with confirmed systemic hyperandrogenism
Non-cooperation of patient
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
2
Hair follicles will be taken from the occipital and frontal scalp areas of the patients simultaneously through the micropunch biopsy method in a sterile operating room after obtaining the consent of the patients.
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethics committee of Tabriz University of Medical Sciences
Street address
Sina hospital, between Hafez and Shahid-Montazeri square, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Approval date
2020-01-20, 1398/10/30
Ethics committee reference number
IR.TBZMED.REC.1398.1134
Health conditions studied
1
Description of health condition studied
Androgenic alopecia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia
Primary outcomes
1
Description
CD31 marker
Timepoint
The morphology of cells will be checked daily for 10 days after cell culture for 3 days.
Method of measurement
Flowcytometry and immunohistochemistry
2
Description
Krt15 marker
Timepoint
The morphology of cells will be checked daily for 10 days after cell culture for 3 days.
Method of measurement
Flowcytometry and immunohistochemistry
3
Description
Ig-β1 marker
Timepoint
The morphology of cells will be checked daily for 10 days after cell culture for 3 days.
Method of measurement
Flowcytometry and immunohistochemistry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Hair follicles will be taken simultaneously from the occipital and frontal scalp areas of the patients through the micropunch biopsy method in a sterile operating room after obtaining the consent of the patients. Then the follicles will be prepared for growth in the culture medium. After filling the bottom of the flask with cultured cells, the culture medium will be centrifuged at the appropriate temperature and speed. Finally, it is washed with flowcytometry buffer and secondary antibody is added to it and incubated again, and at the end surface markers will be examined with flowcytometry device.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Dr. Mohammadreza Ranjkesh
Street address
Sina hospital, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8236
Email
ranjkeshm@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Majid Samiee
Street address
Floor 1, Faculty of Medicine, Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8236
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Ranjkesh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina hospital, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8236
Email
ranjkeshm@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Ranjkesh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina hospital, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8236
Email
ranjkeshm@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Ranjkesh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina hospital, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8236
Email
ranjkeshm@tbzmed.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
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
Study data is categorized and coded with no identifiable individuals.
When the data will become available and for how long
Access to study data after publication of the result is available in the journal.
To whom data/document is available
Anyone interested in using the data can access the study data.
Under which criteria data/document could be used
Study data can be used for comparison with other results.
From where data/document is obtainable
After the publication of the scientific article, applicants can access part of the study information after coordinating with the university's research vice-chancellor. In order to receive the data, the applicants must send their request in the form of an academic email to the scientific officer of the clinical trial and receive the information after coordinating with the research assistant of Tabriz University of Medical Sciences.
What processes are involved for a request to access data/document
The request to use the data is sent to the research vice-chancellor of the university in the form of a written letter using the university's academic email system.