The objective of this clinical trial is evaluation of the effect of Platelet-Rich Plasma (PRP) in the treatment of patients with androgenic alopecia
Design
In this randomized clinical trial, 20 patients with androgenic alopecia without control group will be assigned into the study.
Settings and conduct
In this randomized clinical trial, 20 patients with androgenic alopecia referring to dermatology clinic of Sina hospital of Tabriz will be assigned into the study. Interfollicular injection of Platelet-Rich Plasma (PRP), 0.1 ml/cm2 will be performed 3 times in each patient in selected areas of the scalp at intervals of 30 days. The clinical manifestations and dermoscopy will be used to evaluate the patients with androgenic alopecia. Before the intervention, 2 weeks, 1 month, 3 months after the intervention will be followed up respectively.
Participants/Inclusion and exclusion criteria
Inclusion criteria of the study is Age 18–60 years; Male pattern hair loss (MPHL) and Indication of the participant for PRP injection. Exclusion criteria of the study is platelets disorders; thrombocytopenia; systemic treatments for MPHL (such as finasteride and antiandrogens) in the previous 12 months; bone marrow aplasia; cancer.
Intervention groups
Interfollicular injection of Platelet-Rich Plasma (PRP), 0.1 ml/cm2 will be performed 3 times in each patient in selected areas of the scalp at intervals of 30 days.
Main outcome variables
The clinical manifestations and dermoscopy will be used to evaluate the patients with androgenic alopecia. Before the intervention, 2 weeks, 1 month, 3 months after the intervention will be followed up respectively.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160318027097N11
Registration date:2018-06-02, 1397/03/12
Registration timing:prospective
Last update:2018-06-02, 1397/03/12
Update count:0
Registration date
2018-06-02, 1397/03/12
Registrant information
Name
ِDr Faramarz Darghahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 2000
Email address
mj.naghizadeh@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-05, 1397/03/15
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of effect of Platelet-Rich Plasma (PRP) in the treatment of patients with androgenic alopecia
Public title
Effect of Platelet-Rich Plasma (PRP) in the treatment of androgenic hair loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18–60 years
Male pattern hair loss (MPHL)
Indication of the participant for PRP injection
Exclusion criteria:
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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
Tabriz University of Medical Sciences, Daneshgah Avenue, Tabriz, East Azarbayjan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Approval date
2018-03-06, 1396/12/15
Ethics committee reference number
IR.Tbzmed.REC.1396.1128
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
The androgenic alopecia clinical manifestations
Timepoint
Before the intervention, 2 weeks, 1 month, 3 months after the intervention
Method of measurement
Clinical examinations and dermoscopy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Platelet-Rich Plasma (PRP), 0.1 ml/cm2, Interfollicular injection, 3 times in each patient in selected areas of the scalp at intervals of 30 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Dr Davod Ahmadi Maleki
Street address
Tabriz University of Medical Sciences, Daneshgah Avenue, Tabriz, East Azarbayjan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 45 3351 2006
Email
naghizadeh73@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Street address
Tabriz University of Medical Sciences, Daneshgah Avenue, Tabriz, East Azarbayjan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 45 3351 2000
Email
naghizadeh73@yahoo.com
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 Efat Khodayan
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Tabriz University of Medical Sciences, Daneshgah Avenue, Tabriz, East Azarbayjan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 45 3351 2006
Email
naghizadeh73@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mehdi Amirnia
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Tabriz University of Medical Sciences, Daneshgah Avenue, Tabriz, East Azarbayjan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 45 3351 2006
Email
naghizadeh73@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Davod Ahmadi Maleki
Position
Dermatology Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Tabriz University of Medical Sciences, Daneshgah Avenue, Tabriz, East Azarbayjan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 45 3351 2000
Email
naghizadeh73@yahoo.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
Total potential data after unidentifiable individuals
When the data will become available and for how long
Start the access period from 2019
To whom data/document is available
Researchers in academic and scientific institutions
Under which criteria data/document could be used
Data can be used for scientific and research studies.
From where data/document is obtainable
Dr Davod Ahmad Maleki; Dermatology Assistant; Naghizadeh73@yahoo.com
What processes are involved for a request to access data/document
After receiving the request email, data files will be sent in less than a week