Determining and comparing the effectiveness of the platelet-rich plasma method alone and in combination with microneedling in the treatment of androgenetic alopecia
Design
Each participant is randomly assigned to one of two groups (A or B) based on their choice from a pool of 60 cards. The population of the present study is the group of men suffering with androgenetic alopecia grades 3, 4 and 5. Demographic information of people referred for the treatment of androgenetic alopecia is recorded. Patients are divided into two groups. A group of these patients are treated with PRP alone. The other group is treated with PRP in combination with microneedling.Beginning and post-treatment photos will be taken after follow-up (1 month) along with dermoscopic evaluation (at two fixed points on the scalp). Dry dermoscopy evaluation will be done using DermLite 4 dermatoscope with 10x magnification in polarized mode. Hair pull test will be done before and 1 month after the follow-up.
Settings and conduct
The analyst does not know which participant belongs to which group, allowing unbiased data analysis.The place of study is Razi Hospital and Imam Khomeini Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Male patients aged 18 to 60 years old
2- Androgenic alopecia grades 5, 4, and 3
3- Not taking hormonal drugs and supplements
Exclusion criteria:
1- Having uncontrolled diabetes
2- Tendency keloid
3- Anticoagulant therapy
4- People who have blood phobia
5- Anemia
6- History of malignancy and immunodeficiency diseases
7- People who have received other treatments such as minoxidil or finasteride
8- People with unreasonable expectations of treatment
Intervention groups
A group of these patients are treated with PRP alone. The other group is treated with PRP in combination with microneedling.
Main outcome variables
Androgenic alopecia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241001063231N1
Registration date:2024-11-19, 1403/08/29
Registration timing:registered_while_recruiting
Last update:2024-11-19, 1403/08/29
Update count:0
Registration date
2024-11-19, 1403/08/29
Registrant information
Name
Behnaz Rangriz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8889 6696
Email address
behnazrangriz400@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-11-15, 1403/08/25
Expected recruitment end date
2025-06-15, 1404/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of platelet-rich plasma alone and in combination with microneedling in the treatment of androgenic alopecia
Public title
Evaluation of platelet-rich plasma alone and in combination with microneedling in the treatment of androgenic alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male patients aged 18 to 60 years old
Androgenic alopecia grades 5, 4, and 3
Not taking hormonal drugs and supplements
Exclusion criteria:
Having uncontrolled diabetes
Tendency keloid
Anticoagulant therapy
People who have blood phobia
Anemia
History of malignancy and immunodeficiency diseases
People who have received other treatments such as minoxidil or finasteride
People with unreasonable expectations of treatment
Age
From 18 years old to 60 years old
Gender
Male
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization in this study, the participants are divided into blocks, each block contains a number of participants. Participants are randomly assigned to groups (A or B) in each block. Each participant has an equal chance of
being assigned to groups A or B.
In this study, randomization will be done using SPSS software.
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyst does not know which participant belongs to which group, allowing unbiased data analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University of Medical Sciences Faculty of Medicine
Street address
Ghods St., Porsina St., Faculty of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1936893813
Approval date
2023-11-29, 1402/09/08
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.488
Health conditions studied
1
Description of health condition studied
آلوپسی آندروژنتیک
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia
Primary outcomes
1
Description
Hair growth rate
Timepoint
Both groups will receive treatment in three sessions at four-week intervals.
Method of measurement
Beginning and post-treatment photos will be taken after follow-up (1 month) and dermoscopic evaluation (at two fixed points on the scalp). Dry dermoscopy evaluation will be done using DermLite 4 dermatoscope with 10x magnification in polarized mode. A hair pull test will be done before and 1 month after the follow-up.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A group of these patients will treated with PRP (kits from a fixed company) with a 30-gauge insulin syringe alone.
Category
Treatment - Drugs
2
Description
Intervention group: The other group is treated by applying PRP to the head in combination with microneedling (A6 36-needle device).