The purpose of this study is to compare the effectiveness of topical spironolactone five percent with progesterone two percent in the treatment of patients with grade one or two female pattern androgenetic alopecia. This is a randomized; double-blind trial without a placebo and single center study. 72 patients diagnosed with grade one or two androgentic alopecia will be enrolled in this study; patients will be randomized in two parallel groups. After obtaining informed consent from patients; patients will be divided into two groups. Group of patients will be treated for 24 weeks with spironolactone five percent and progesterone two percent. The patients will be examined bi monthly for 6 months. The examination will be included measurement of hair density per squared centimeters and hair diameter. Criteria for improvement; will be the increase hair numbers or increase hair diameter.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512252581N4
Registration date:2016-12-14, 1395/09/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-14, 1395/09/24
Registrant information
Name
Hamide Herizchi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 4650
Email address
herizchih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Spironolcatone 5% and Progesterone 2% on hair density and diameter in female pattern androgenetic alopecia
Public title
Comparison of the efficacy of Spironolcatone 5% and Progesterone 2% on hair density and diameter in female pattern hair loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: female; grade 1 or 2 androgenetic alopecia; no underlying hormonal disorders
Exclusion criteria: patient's decision to exit the study; underlying hormonal disorder; anemia; use of topical medications in the past week; taking oral medications in the past four weeks; have allergy to spironolactone or progesterone; pregnancy or planning to pregnancy or breastfeeding
Age
No age limit
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Siences
Street address
Third floor, Tabriz Medical Sciences University, Gholgasht ave
City
Tabriz
Postal code
Approval date
2015-06-08, 1394/03/18
Ethics committee reference number
tbzmed.rec.138.222
Health conditions studied
1
Description of health condition studied
Female pattern andrpgenetic alopecia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia
Primary outcomes
1
Description
Hair density per squared cm, Hair diameter
Timepoint
At baseline, 8th, 16th ,24th weeks
Method of measurement
Trichoscopy
Secondary outcomes
1
Description
Side effects
Timepoint
At baseline, 8th, 16th and 24th weeks
Method of measurement
Qualitative
Intervention groups
1
Description
Control group; Topical 2% Progesterone solution, twice a day for 24 weeks
Category
Treatment - Drugs
2
Description
Intervention group; Topical 5% Spironolactone solution, twice a day for 24 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital, Dermatology clinic
Full name of responsible person
Herizvhi ghadim Hamideh
Street address
Sina Hospital, Dermatology department
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Rashidi Mohammad Reza
Street address
Golgasht Ave., Daneshgah St., Tabriz, Iran
City
Tabriz
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, 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 University of Medical Siences
Full name of responsible person
Herizchi ghadim Hamideh
Position
Dermatologist, associate professor
Other areas of specialty/work
Street address
Golgasht Ave., Daneshgah St., Tabriz, Iran
City
Tabriz
Postal code
5163639888
Phone
+98 41 3540 6612
Fax
+98 415412151
Email
drherizchi@yahoo.con
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Herizchi ghadim Hamideh
Position
Dermatology specialist, Associate professor
Other areas of specialty/work
Street address
Golgasht Ave., Daneshgah St., Tabriz, Iran
City
Tabriz
Postal code
5163639888
Phone
+98 41 3540 6612
Fax
+98 415412151
Email
herizchih@tbzedmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Siences
Full name of responsible person
Zeinolabedin zadeh Vahideh
Position
Dermatology Resident
Other areas of specialty/work
Street address
Golgasht Ave., Daneshgah St., Tabriz, Iran Ta
City
Tabriz
Postal code
Phone
+98 41 3541 2101
Fax
Email
vahide.abediny@ gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)