Study of safety and effectiveness of mesenchymal stem cells condition medium and 665nm low level diode laser hat in the treatment of androgenetic alopecia
Study of safety and effectiveness of mesenchymal stem cells secretome and 665nm low level diode laser hat in the treatment of androgenetic alopecia
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 CM injection in five sessions with an interval of one month between 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 CM injections in five 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 CM injection, laser cap, CM injection and laser cap.
Participants/Inclusion and exclusion criteria
Inclusion criteria: androgenetic alopecia type 2-4, no use of topical or oral medication for the treatment of alopecia during the last six months. Exclusion criteria: age under 18, pregnancy, lactation, history of malignancies, take any topical or systemic treatment during the study.
Intervention groups
The first group is treated with CM injection in five 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 CM injections in five sessions with an interval of one month each, during which they use 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:IRCT20200127046282N27
Registration date:2023-04-23, 1402/02/03
Registration timing:prospective
Last update:2023-04-23, 1402/02/03
Update count:0
Registration date
2023-04-23, 1402/02/03
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
2023-04-30, 1402/02/10
Expected recruitment end date
2023-08-01, 1402/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of safety and effectiveness of mesenchymal stem cells condition medium and 665nm low level diode laser hat in the treatment of androgenetic alopecia
Public title
Comparison of the efficacy of mesenchymal stem cells condition medium injection and ow level laser in the treatment of alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Androgenetic alopecia Type 2-4
Do not take topical or oral medication to treat alopecia in the last six months
Exclusion criteria:
Age under 18 years
Pregnancy
Breastfeeding
History of malignant diseases
Take any topical or systemic treatment during the study
Age
From 18 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
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 condition medium (CM) injection in five 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 CM injections in five 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
Organizational committee of ethics in biomedical research Shahid Beheshti University of Medical Scie
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi Ave, Yaman Ave, Velenjak
City
Tehran
Province
Tehran
Postal code
1989934148
Approval date
2022-11-13, 1401/08/22
Ethics committee reference number
IR.SBMU.REC.401.020
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
Questionnaire and visit
3
Description
Tolerability
Timepoint
Each session after transplantation
Method of measurement
Questionnaire and visit
Intervention groups
1
Description
Control group: Patients are treated with CM injections in five sessions with an interval of one month each.
Category
Treatment - Other
2
Description
Control group: Patients are treated with laser caps three times a week for 10 minutes each time.
Category
Treatment - Other
3
Description
Intervention group: Patients are treated with CM injections in five 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
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
Subspecialist
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