Title: Effect of platelet-rich plasma (PRP) on androgenic alopecia in men 25-45 years.
Specific objectives: to evaluate the effect of platelet-rich plasma in patients with androgenetic alopecia by age, starting for baldness, hair density before treatment and the extent of baldnes.
Methods: patients enrolled in the study, men who are 25 to 45 years with androgenic alopecia( AGA).
30 to 35 cc of blood is taken from them and using centrifugation to obtain platelet-rich plasma. For each patient, two regions with the lowest density of scalp hair have been selected.the area of each zone was 2.5 cm to 2.5 cm, and were 2.5 cm apart from each other and the extent of this area was identified by a tattoo. Injections are performed between the dermis and subcutaneous. Injections are administered on the first day and then repeated one month later. Afterwards, villouses and terminal hair counts each region, determines the response to treatment. It takes place at the beginning of the study. Using a magnifying glass. And 1, 3 and 6 months after the regions will be counted.
The beneficial effects of PRP in androgenic alopecia (AGA) can thus be attributed to various platelet-derived growth factors causing improvement in the function of hair follicle and promotion of hair growth. It is safe, cheap, and non-allergic and it appears to be a useful adjuvant in the management of AGA.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013072814190N1
Registration date:2013-08-21, 1392/05/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-21, 1392/05/30
Registrant information
Name
Mohammad Bahadoram
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3011
Email address
bahadoram.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jundishapur University of Medical Sciences, Vice Chancellor for Research and Technology
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of platelet- rich plasma effect on androgenic alopecia in men aged 25-45 years
Public title
Effect of Platelet-rich plasma treatment of male pattern baldness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: androgenetic alopecia according to the following scales: men: Hamilton/Norwood Scale: grades Va- VII and possibility of follow-up during the study.
Exclusion criteria:active inflammation or infection in the intervention area; presence of active systemic infections; background of cancerous or precancerous lesions; suffering from any serious blood disorders; to have undergone treatments for alopecia in the previous 6 months; previous hair implants; intake of drugs that affect hair loss; be undergoing immunosuppressive therapy and/or anticoagulants.
Age
From 25 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
19
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahwaz Ethic Committee of Jundishapur University of Medical Sciences
Street address
Esfand avenue, Golestan bulvard ,Ahwaz Jundishapur University of Medical Sciences
City
Ahwaz
Postal code
15794-61357
Approval date
2013-08-06, 1392/05/15
Ethics committee reference number
ajums.rec.1392.87
Health conditions studied
1
Description of health condition studied
Androgenetic Alopecia
ICD-10 code
L64.9
ICD-10 code description
Androgenic alopecia, unspecified
Primary outcomes
1
Description
Change from baseline in Hair density
Timepoint
6 month
Method of measurement
Hair density (number of hairs per cm2) will be measured for each case
Secondary outcomes
1
Description
Infection
Timepoint
1 weak after Injection
Method of measurement
Clinical
Intervention groups
1
Description
at the first, the Site was sterilized with alcohol,Using a 19-gauge needle, 10 ml of blood was collected in sterile conditions.afterwards,The sample was inserted in a disposable PRP kit.And Was shaken to mix the blood with the anticoagulant. Then placed in a centrifuge machine,Santryfyvzhshd speed of 3000 rpm for 6 minutes.When the plasma was separated from blood cells.The second time was centrifuged at a speed of 3300 rpm for 3 min.Thus, the plasma concentration of platelets (PRP) was obtained.
Compared with the patient's blood platelet count was more than 5 times in the sample. Finally,Calcium gluconate was added to the PRP, And creates favorable conditions for injection.PRP was prepared by the Department of Dermatology, Imam Khomeini Hospital, Ahwaz.For each patient, two regions with the lowest density of scalp hair have been selected.the area of each zone was 2.5 cm to 2.5 cm, And were 2.5 cm apart from each other and the extent of this area was identified by a tattoo.Injections are performed between the dermis and subcutaneous.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz Dermatology Center of Emam Khomeiny Hospital
Full name of responsible person
Dr Mohamad Ali Mapar
Street address
Esfand avenue, Golestan bulvard, Ahwaz Jundishapur University of Medical Sciences
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences, Vice Chancellor for Research and technology
Full name of responsible person
Dr.Mostafa Feghhi
Street address
Esfand avenue, Golestan bulvard ,Ahwaz Jundishapur University of Medical Sciences
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz Jundishapur University of Medical Sciences, Vice Chancellor for Research and technology
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
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Sadegh shahryari
Position
Dermatology Resident
Other areas of specialty/work
Street address
Esfand avenue, Golestan bulvard ,Ahwaz Jundishapur University of Medical Sciences
City
Ahwaz
Postal code
Phone
+98 61 1222 2114
Fax
Email
Sadegh_shahryari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Mohamad Ali Mapar
Position
Dermatologist
Other areas of specialty/work
Street address
Esfand avenue, Golestan bulvard ,Ahwaz Jundishapur University of Medical Sciences
City
Ahwaz
Postal code
6193673166
Phone
+98 61 1222 2114
Fax
+98 61 1292 1837
Email
Mapar@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Mohamad Ali Mapar
Position
Dermatologist
Other areas of specialty/work
Street address
Esfand avenue, Golestan bulvard ,Ahwaz Jundishapur University of Medical Sciences
City
Ahwaz
Postal code
6193673166
Phone
+98 61 1222 2114
Fax
+98 61 1292 1837
Email
Mapar@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)