This study is for assessment of PRP local injection in hair loss treatment among males suffering from androgenetic alopecia between grade 3v to 5 according Hamilton-Norwood scaling system. Written informed consent was obtained. Volunteers were selected from patients in Mashhad Quaem hospital`s skin clinic in 2015. In every session, 50cc of blood volume was taken from brachial vein and then in sterile condition for separating autologous platelets sent to stem cell lab in Mashhad college of medicine that has specific clean room. After preparation, approximately 5cc of PRP was obtained. This concentrate has fourfold to eightfold more platelet and growth factors. Immediately after preparation, this platelet concentrate is injected by dermatology resident with local anaesthesia and intradermally. This procedure is performed for 3 sessions with 4 weeks interval. Digital photography (with 20 cm distance) and dermatoscopy images in constant locations (determining with an equal distance from a point exactly upside eyebrows in midpuppil line to vertex area in midline) is performed in weeks 0, 4, 8 and 12 as well as 3 months after last injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016021526563N1
Registration date:2016-05-29, 1395/03/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-29, 1395/03/09
Registrant information
Name
Mohammad Javad Yazdanpanah
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2851
Email address
yazdanpanahmj@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mashhad University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of autologous Platelet-Rich Plasma Injections in the Treatment of male pattern Androgenetic Alopecia
Public title
Effect of PRP on male pattern hair loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients include males with male pattern androgenetic alopecia who had acquiescence for participation in this study and their baldness is grade 3v to 5 according to Hamilton-Norwood scaling system. Exclusion criteria: using minoxidil or finasteride in the last 6 months; using any other systemic or topical supplementary drugs for hair growth stimulation in the last 6 months; using drugs that can induce hair loss (eg. Retinoids, heavy metals, antithyroids, anticonvulsants, betablockers and …); specific diseases like thyroid disease, collagen vascular disease …; positive history for any kind of cancer or skin cancer and chemotherapy; any other kind of alopecia ( scaring alopecia, alopecia areata, …); steroid therapy; coagulation disorders, acquisition of aspirin, ticlopidine or other anticoagulative drugs; dialysis patients and platelet disorders (thrombocytopenia); smoker and alcoholic persons and malnutrition; and anytime patient wants to leave the study.
Age
From 28 years old to 60 years old
Gender
Male
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 Mashhad University of Medical Sciences
Street address
Central building of Mashhad University of Medical Sciences(Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Postal code
Approval date
2015-01-21, 1393/11/01
Ethics committee reference number
930092
Health conditions studied
1
Description of health condition studied
Male androgenetic alopecia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia
Primary outcomes
1
Description
Hair loss improvement and stimulation of hair growth
Timepoint
Measurement on weeks 0, 4, 8, 12 and 3 months after last injection
Method of measurement
Average hair diameter and hair count in unit surface
Secondary outcomes
1
Description
Side effects
Timepoint
At the end of treatment (3 months after last injection)
Method of measurement
Effectiveness and side effects include local and systemic reactions according to patients and investigator observations
Intervention groups
1
Description
injection of Platelet-Rich Plasma (PRP) 3 times in 4 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic, Quaem Hospital
Full name of responsible person
Dr Mohammad Javad Yazdanpanah
Street address
Department of dermatology, Quaem hospital, Ahmad Abad Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
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 of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammad Javad Yazdanpanah
Position
Professor of dermatology
Other areas of specialty/work
Street address
Dermatology clinic, Quaem hospital, Ahmad Abad Street
City
Mashhad
Postal code
Phone
+98 51 3801 2493
Fax
Email
yazdanpanahmj@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammad Javad Yazdanpanah
Position
Professor of dermatology
Other areas of specialty/work
Street address
Department of dermatology, Quaem Hospital, Ahmad Abad Street
City
Mashhad
Postal code
Phone
+98 51 3801 2851
Fax
Email
yazdanpanahmj@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Akram Sadat Momenzadeh
Position
Bachelor of Biology
Other areas of specialty/work
Street address
Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 51 3841 0135
Fax
Email
momenzadeha1@mums.ac.ir; src@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)