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Efficacy and safety of platelet-rich plasma (PRP) in the treatment of male pattern hair loss (androgenetic alopecia): a pilot, phase 2 clinical trial

Protocol summary

Summary
The aim of our study is to evaluate the efficacy and safety of PRP (Platelet Rich Plasma) in patients with androgenic alopecia. 15 male patients with androgenic alopecia with the age of 18-60 years old will enrolled in our study after evaluated by dermatologist. The volunteers with the Hamilton-Norwood grade of III-VI with the history of alopecia for more than 6 months without any anti hair loss treatment during the past six months will be selected. The participants should have no systemic diseases which interfering with the hair growth, hematologic or autoimmune disorders. The platelet counts and serum albumin level should be >100000 and >2.5 g/dl respectively. All participants were informed of the risks, benefits, and possible complications of the treatment, and each participant provided investigators with a written informed consent. The lab tests for CBC and serum albumin will be evaluated. By digital cameras (Nikon D300s®,Tokoyo, Japan) investigators will take standard photographs. A trichogram will be performed in 5 areas including right frontal, left frontal, right temproparietal, left temproparietal and vertex. Then investigators will take photos of an area with the lowest hair density marked with tattoo on the scalp and using a digital photographic hair analyzer (KC Triple Scope®, KC Technology co, Korea) by a 150x lens to measure hair density and hair diameter. The treatment courses are 5 sessions every two weeks. In each session 8cc of venues blood will draw and after processing by the routine kit protocol, the PRP will immediately injected in scalp with the intervals of 1-2cm. patients will evaluated 3 months after the last session.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014110919870N1
Registration date: 2014-12-15, 1393/09/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-12-15, 1393/09/24
Registrant information
Name
Mansour Nassiri Kashani
Name of organization / entity
Center for Research and Training in Skin diseases and Leprosy
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 2220
Email address
nasirika@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
1.Mehrashkar company2.Vice Chancellor for research of Tehran University of Medical Sciences
Expected recruitment start date
2014-11-20, 1393/08/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of platelet-rich plasma (PRP) in the treatment of male pattern hair loss (androgenetic alopecia): a pilot, phase 2 clinical trial
Public title
Efficacy and safety of platelet-rich plasma (PRP) in the treatment of male pattern hair loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Androgenetic alopecia based on a clinical diagnosis made by a dermatologist;male subjects; 18-50 years old; hair loss longer than 6 months; Hamilton-Norwood grade III-VI;Willingness to participate in the study and giving written informed consent. Exclusion criteria: Any topical or systemic treatment for hair loss in the past 6 months;Scalp infection Malignant disease;Receiving chemotherapy or any immunosuppressive medication Auto-immune disease (Hashimoto, rheumatoid arthritis, lupus, ….);Use of any growth factor containing medication;Hemoglobin level below 10, thrombocytopenia (or platelet count below 100,000);Serum albumin below 2.5 g/dl;History of vascular surgery in the past three months;Addiction to oral or intravenous narcotics; Any systemic disease interacting with hair growth ;History of hematologic disorders; Patient currently enrolled or previously enrolled (within last 3 months) in another clinical trial
Age
From 18 years old to 60 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
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
Research Ethics Committee of Tehran University of Medical Sciences
Street address
Qouds st, keshavarz blv
City
Tehran
Postal code
Approval date
2014-11-09, 1393/08/18
Ethics committee reference number
81633613

Health conditions studied

1

Description of health condition studied
androgenic alopecia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia Incl.: male-pattern baldness

Primary outcomes

1

Description
increase hair density
Timepoint
after 10 weeks
Method of measurement
trichography

Secondary outcomes

1

Description
increase hair thickness
Timepoint
after 10 weeks
Method of measurement
trichography

Intervention groups

1

Description
use platelet rich plasma in treatment of androgenetic alopecia in male patients
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Center for Research and Training in Skin diseases and Leprosy
Full name of responsible person
Street address
415, Taleghani street, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mehrashkar company
Full name of responsible person
Mehdi Dehghani
Street address
11 khazan st, West Fatemi
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mehrashkar company
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
Center for Research and Training in Skin diseases and Leprosy
Full name of responsible person
Saman Ahmad Nasrollahi
Position
Pharmacologist/Assistant prof
Other areas of specialty/work
Street address
415, Taleghani street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8897 2220
Fax
Email
samannasrol@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Center for Research and Training in Skin diseases and Leprosy
Full name of responsible person
Azin Ayatollahi
Position
Dermatologist
Other areas of specialty/work
Street address
415, Taleghani street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8897 2220
Fax
Email
azinay@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Center for Research and Training in Skin diseases and Leprosy
Full name of responsible person
Azin Ayatollahi
Position
Dermatologist
Other areas of specialty/work
Street address
415, Taleghani street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8897 2220
Fax
Email
azinay@gmail.com
Web page address

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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