Increasing hair growth by injecting SVF and PRP in a comparative manner in the scalp of AGA patients
Design
The clinical trial with two parallel groups, double-blind, randomized, phase 2, each group including 12 patients, was used to randomize the rand function of Excel software.
Settings and conduct
The study is conducted in Razi Skin Hospital in a double-blind manner, so that the doctor and the patients are not aware of the chosen injectable substance.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Age above 18 years
• Diagnosis of AGA based on clinical examination and trichoscopy
• Active hair loss in the last 12 months
• Norwood-Hamilton grades II-VI or Ludwig Class I-III
• Those who have enough abdominal or subcutaneous fat tissue that is accessible with a syringe.
Exit criteria:
• In case of other treatments for hair loss in the last 3 months
• History of hair transplant
• Systemic diseases or scalp diseases that may affect hair growth.
• Simultaneous treatment with other AGA treatments
• Pregnancy
Intervention groups
This study was designed as a double-blind randomized interventional clinical trial to investigate the safety and efficacy of local SVF and PRP injection in a comparative manner to 22 candidates with androgenetic hair loss. In this study, patients are studied in two groups of 12 people. These groups include SVF recipient group and PRP .
Main outcome variables
The number of terminal hairs - the number of vellus hairs - the thickness of the hairs - the density of the hairs
A comparative study of the effect of SVF and PRP in the treatment of androgenetic alopecia in the patients of Razi Hospital
Public title
Comparative study of the effect of SVF and PRP in the treatment of hereditary hair loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years
Those who have enough abdominal or subcutaneous fat tissue that is accessible with a syringe
Norwood-Hamilton grades II-VI or Ludwig Class I-III• .
Active hair loss in the last 12 months•
Diagnosis of AGA based on clinical examination and trichoscopy
Exclusion criteria:
In case of other treatments for hair loss in the last 3 months •
Pregnancy
• Simultaneous treatment with other AGA treatments
Systemic diseases or scalp diseases that may affect hair growth
History of hair transplant
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Random number
The table of random numbers is a massive collection of
It is numbers that have no specific pattern or order
The face is completely randomly generated and so on
The table has been created. To use the table
Random numbers, first the researcher should read the numbers
Predetermine the table (for example, top, bottom, left
or right), the second valid premise in view
Getting numbers for different groups (eg
Example of even numbers for intervention A and odd numbers for
Intervention B, another method of considering numbers
00-24 for intervention A and numbers 25-49 for
Intervention B, numbers 50-74 for group C and numbers
75-99 is for group D), then the researcher in
He moved in one of the predetermined directions and recorded the numbers
Allocates different groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
.To conduct the study, fat is taken from one group of patients to prepare SVF and blood is taken from another group to prepare PRP by the research doctor, so there is no possibility of blinding the researcher and the patients . But the person who checks the results remains unaware of which person injected which substance, and without knowing the type of injected substance, she comments on the effectiveness of the injection treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Medicine - Tehran University of Medical Sciences (Research Ethics Committee)
Street address
Amirabad- North Kargar St. - Koi Girls Dormitory - next to Haft Store
City
Tehran
Province
Tehran
Postal code
1439955975
Approval date
2024-05-22, 1403/03/02
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.069
Health conditions studied
1
Description of health condition studied
androgenic alopecia
ICD-10 code
L64.9
ICD-10 code description
Androgenic alopecia, unspecified
Primary outcomes
1
Description
Androgenic alopecia score based on Norwood-Hamilton scale or Ludwig scale
Timepoint
Before treatment, 3 months and then 6 months after starting treatment
Method of measurement
In our study 《Comparison of the effect of SVF and PRP on increasing the density and thickness of hair》, the outcome variable is measured by videotrichoscope and clinical photography.
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: a group with androgenetic alopecia for whom three injections (0.1 ml/cm2 of SVF) are performed in the scalp at intervals of 0, 3 and 6 months. (The Coleman technique was used for fat grafting. First, Klein's anesthetic solution was administered using (500 mL of 0.9% sodium chloride, 25 mL of 2% lidocaine, and 0.5 mL of epinephrine). After that, the fat tissue was It was removed with a Sorensen cannula connected to a 20 ml Luer-Lock syringe.Suction was achieved by applying a constant negative pressure. After collecting 80 ml of fat, the condensation process was started by centrifuging the aspirated fat at 500 g power for 2 minutes to separate the swollen material and blood elements in the lowest layer, which was then discarded. It was enough.After centrifugation, the aspirated fat was mechanically emulsified using the Tulip NanoTransfer kit through 2.4, 1.4 and 1.2 mm Luer-to-Luer connectors. 30 passes were passed through each connector with minimal pressure to achieve successful mechanical micronization of fat.The micronized fat was subjected to another centrifuge with a force of 1200 g for 3 minutes to remove the oil. Then, the emulsified fat residue was filtered once through a two-layer filter of 400 and 600 micrometers. Finally, the product was centrifuged at 1200 g for 6 min, resulting in 3 layers with the SVF pellet at the bottom. After SVF isolation, the scalp was injected intradermally with 0.1 ml/cm2 of SVF using 30 g syringes under strict sterile conditions. Patients were examined one week after the operation in terms of detecting any side effects such as pain, edema, or bruising.
Category
Treatment - Other
2
Description
The second intervention group is a group with androgenetic alopecia, for whom three PRP injections are performed in the scalp at intervals of 0, 3 and 6 months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Delnia Shiri
Street address
Koi Girls' Dormitory - in front of Al-Nabi Mosque - North Kargar St. - Amirabad
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 914 541 6327
Email
shirydlnia@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nima Rezayi
Street address
Koi Girls' Dormitory opposite Masjid al-Nabi - North Kargar St
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 914 541 6327
Fax
Email
shirydlnia@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
10
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
Delnia Shiri
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
North karegar
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 44 4244 0626
Fax
Email
shirydlnia@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Delnia Shiri
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
North karegar
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 44 4244 0626
Fax
Email
shirydlnia@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Delnia Shiri
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
North karegar
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 44 4244 0626
Fax
Email
shirydlnia@gmail.com
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
The participants' data file, study protocol, informed consent form, clinical study report, codes used in the analysis, data dictionary will all be provided after the completion of the study and publication of the results. After making people unidentifiable, a part of the data related to the main result will be available .
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Analysis for use in industry will be allowed by providing documentation regarding the type of use.
From where data/document is obtainable
To receive information, use the address shirydlnia@gmail.com
What processes are involved for a request to access data/document
The applicant should send the necessary documents about working in academic and scientific institutions and the type of requested information to the above email address and wait for the reply.