This randomized controlled trial is performed among a group of 88 patients attending to clinics of Skin and Stem cell Research Center of Tehran scheduled for hair transplantation surgery. Inclusion Criteria: Subjects are recruited from a group of patients attending to clinics of Skin and Stem cell Research Center of Tehran scheduled for hair transplantation surgery. Exclusion Criteria: Patients who will not return for follow up visits or are not willing to participate will be excluded. The protocol of the trial is described in details and a written consent would be obtained from all subjects. Patients are randomly assigned into two groups. The first group will receive routine hair transplantation surgery by follicular unit transplantation (FUT) method and are considered as the control group. The second group will receive both Platelet- rich plasma (PRP) and FUT methods. A sample of 20 cc of whole blood would also be obtained from participants of the second group. In this study the major independent variable is treatment groups and the number and thickness of successful transplanted follicular units would be measured as the dependent variable. Patients in both groups will receive standard medical therapy. After transplantation daily finasteride and topical minoxidil initiating at 2 weeks postoperatively will be prescribed in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904021159N5
Registration date:2013-09-08, 1392/06/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-08, 1392/06/17
Registrant information
Name
Mohamad Ali Nilforoushzadeh
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 5158
Email address
sdlrc@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of thickness and number of follicular units with or without Platelet- rich plasma in hair transplantation procedure
Public title
Comparison of follicular units with or without Platelet- rich plasma in hair transplantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Subjects are recruited from a group of patients attending to clinics of Skin and Stem cell Research Center of Tehran scheduled for hair transplantation surgery.
Exclusion Criteria: Patients who will not return for follow up visits or are not willing to participate will be excluded.
Age
From 25 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
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 Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Enghelab Street, Tehran, Iran
City
Tehran
Postal code
Approval date
2012-06-11, 1391/03/22
Ethics committee reference number
56317
Health conditions studied
1
Description of health condition studied
Alopecia
ICD-10 code
L65.9
ICD-10 code description
Nonscarring hair loss
Primary outcomes
1
Description
Number of follicular units
Timepoint
Before transplantation and 4, 8, 12 months after transplantation
Method of measurement
Trichoscan
2
Description
Thickness of follicular units
Timepoint
Before transplantation and 4, 8, 12 months after transplantation
Method of measurement
Trichoscan
Secondary outcomes
empty
Intervention groups
1
Description
Hair transplantation by follicular unit transplantation (FUT) method: One time, a thin donor with 1-2 cm width is received from back of head and then is divided to follicular units by strereo microscope and transplanted in recipient site.
Category
Treatment - Surgery
2
Description
Hair transplantation by Platelet- rich plasma (RPR) plus follicular unit transplantation (FUT) method: One time, a 20 cc blood sample is obtained from each participant, and will be centrifuged for 5 minutes at 1400 rpm to separate blood cells from platelets by Tubex kit (from Seoul, South Korea) in Selex centrifuge. A part of obtained suspension will be kept for maintaining the grafts while the other part is sprayed during the hair transplantation procedure.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Azadeh Zolfaghari
Street address
Tehran University of Medical Sciences, Enghelab Street, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Vice chancellor for research, Tehran University of Medical Sciences, Enghelab Street, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Ir
Full name of responsible person
Azadeh Zolfaghari
Position
MSc
Other areas of specialty/work
Street address
Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Sedigheh Tahereh (AS) Research Centers Complex, Khorram Ave., Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1337 3736
Fax
Email
ms_a_zoolfaghari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Position
Associate professor
Other areas of specialty/work
Street address
Skin and Stem Cell Research Center, third floor, no 4, Maryam impasse, Kamranieh st, Tehran
City
Tehran
Postal code
Phone
+98 21 2221 2537
Fax
Email
sdlrc@mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)