Our aim in this study is to evaluate the impact of topical finesteride on the treatment of androgenic alopecia. In a randomized, non-blinded, unicentral clinical trial, 58 patients from both genders with androgenic alopecia referring to the dermatology clinics of Sina hospital, Tabriz, Iran, will be evaluated. The key inclusion criteria is to have androgenic alopecia and key exclusion criteria are to be pregnant; to have non-androgenic alopecia in other regions of the body. All of the patients would be treated with topical finasteride solution for a 12-month period once a day. Type of androgenic alopecia, number of lost hair obtained from a hair loss test and mean hair diameter will be measured before and 3, 6, 9 and 12 months after the initiation of the treatment. Obtained values will be recorded and evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202048917N1
Registration date:2012-03-10, 1390/12/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-10, 1390/12/20
Registrant information
Name
Javad Shokri
Name of organization / entity
Faculty of Pharmacy, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 2583
Email address
shokrij@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-06-30, 1390/04/09
Expected recruitment end date
2012-03-30, 1391/01/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of topical finasteride on treatment of patients with androgenic alopecia
Public title
The impact of topical finasteride on male-pattern baldness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: (to have androgenic alopecia of any type)
Exclusion criteria: (to be pregnant; to have non-androgenic alopecia in other regions of the body; to have signs of allergy to finasteride)
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
58
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 Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Tabriz Medical University, Daneshgah square
City
Tabriz
Postal code
Approval date
2009-04-09, 1388/01/20
Ethics committee reference number
87/1-2/14
Health conditions studied
1
Description of health condition studied
Androgenic alopecia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia
Primary outcomes
1
Description
Number of lost hair
Timepoint
Before the initiation of the treatment and 3, 6, 9 and 12 month after the initiation of the treatment
Method of measurement
Using hair loss test
2
Description
Hair diameter
Timepoint
Before the initiation of the treatment and 3, 6, 9 and 12 month after the initiation of the treatment
Method of measurement
Using a micrometer under a microscope
3
Description
Type of androgenic alopecia
Timepoint
Before the initiation of the treatment and 3, 6, 9 and 12 month after the initiation of the treatment
Method of measurement
Based on protocol
Secondary outcomes
empty
Intervention groups
1
Description
Administeration of topical finasteride 2% solution for all the patients for a 12-month period to be used on the skulp skin with hair loss once each night.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinics of Sina hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostad Rahimi
Street address
Vice chancellor for research, Tabriz Medical Unversity, Daneshgah square
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz Medical University
Full name of responsible person
Javad Shokri
Position
Pharmaceutics, associate professor
Other areas of specialty/work
Street address
Faculty of Pharmacology, Tabriz Medical University
City
Tabriz
Postal code
Phone
+98 41 1337 2583
Fax
Email
shokri.j@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz Medical University
Full name of responsible person
Javad Shokri
Position
Pharmaceutics, Associate professor
Other areas of specialty/work
Street address
Faculty of Pharmacology, Tabriz Medical Universty
City
Tabriz
Postal code
Phone
+98 41 1337 2583
Fax
Email
shokri.j@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Medical University
Full name of responsible person
Javad shori
Position
Pharmaceutics, associate professor
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
shokri.j@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)