Protocol summary

Summary
The aim of this study is to examine the effect of plasma rich platelet on androgenic hair loss. This effect is compared against the effect finastride and placebo. The sample consists of one hundred and twenty male patients aged 20 to 35 with androgenic hair loss hamilton grade 2 and 3, non of the selected patients has the systemic or scalp skin disease. subjects are randomly divided to three groups. The first group consisting of 30 patients,are to be treated with plasma rich platelet. The second group of the same size are to be treated with finastride on a daily dosage of 1 gram, whereas the third group , composed of 60 cases, receive placebo once a day and apply it on their head. This three groups are followed 3 and 6 months, and on each follow up session, photos are taken . By comparing these photos against the photos taken before the treatment, the amount of hair growth will be evaluated.

General information

Acronym
PRP(plasma rich platelet )
IRCT registration information
IRCT registration number: IRCT2014062918210N2
Registration date: 2014-09-17, 1393/06/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-09-17, 1393/06/26
Registrant information
Name
Elham Behrangi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 2040
Email address
behrangi.e@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran university
Expected recruitment start date
2013-01-31, 1391/11/12
Expected recruitment end date
2014-01-31, 1392/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of plasma rich platelet with finastride and placebo on androgenic hair loss
Public title
Evaluation the effect of blood platelet on androgenic hair loss
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: androgenic alopecia Hamilton grade 2 and 3; 20-35 years old men;normal laboratory tests of TSH, CBC AND ferritin ; do not use oral finastride or topical minoxidil for the last 3 months.Exclusion criteria:another systemic or topical disease on the scalp;use of telogen effluvium drugs;nutritional disease;scarring alopecia)
Age
From 20 years old to 35 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Iran University Of Medical sience
Street address
Iran university -Hemat Highway
City
Tehran
Postal code
19922347512
Approval date
2014-06-15, 1393/03/25
Ethics committee reference number
92033024245101449

Health conditions studied

1

Description of health condition studied
Androgenetic alopecia
ICD-10 code
L64.9
ICD-10 code description
Androgenetic alopecia

Primary outcomes

1

Description
Androgenetic alopecia
Timepoint
3 months and 6months later
Method of measurement
Photography

Secondary outcomes

1

Description
Hair growing
Timepoint
3months and 6 months later
Method of measurement
Photography

Intervention groups

1

Description
Interventional group:plasma rich platelet,is uptaken from their blood after sentrifuge
Category
Treatment - Other

2

Description
Control group1:take 1 miligram finastride daily
Category
Treatment - Drugs

3

Description
Control group2:apply placebo once aday on their head,placebo composed of 25% alcohol and 75% N/S
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool Hospital
Full name of responsible person
Dr Elham Behrangi
Street address
Satarkhan st , Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor of Iran university of Medical science-Research committee
Full name of responsible person
Dr Morteza Naserbakht
Street address
Iran university_Hemat Highway
City
Tehran
Grant name
_
Grant code / Reference number
92033024245
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Iran university of Medical science-Research committee
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
Iran University of Medical Science
Full name of responsible person
Dr Elham Behrangi
Position
Professor
Other areas of specialty/work
Street address
Dermatology Department,Rasool Hospital,Satarkhan Street
City
Tehran
Postal code
1445613131
Phone
+98 21 6650 2040
Fax
+98 21 6650 2040
Email
behrangi.e@iums.ac.ir
Web page address
www.iums.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iiran University of Medical Science
Full name of responsible person
Dr elham behrangi
Position
Professor
Other areas of specialty/work
Street address
Dermatology Department-Rasool Hospital,Satarkhan Street
City
Tehran
Postal code
1445613131
Phone
00
Fax
+98 21 6650 2040
Email
behrang.e@iums.ac.ir
Web page address
www.iums.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Dr Elham Behrangi
Position
Professor
Other areas of specialty/work
Street address
Dermatology Department, Rasool Hospital, Satarkhan Street
City
Tehran
Postal code
1445613131
Phone
+98 21 6650 2040
Fax
+98 21 6650 2040
Email
behrangi.e@iums.ac.ir
Web page address
www.iums.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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