The main purpose of the study is treatment of hirsutism with topical formulation of systemic drug to lessen the side effects. Also this formulation is cheaper and more available than other treatments for this disease. The duration of this randomized, double blinded study that is controlled with placebo is 6 months and is under observation of a dermatologist. Women after puberty that have hirsutism criteria (based on Ferriman-Gullway scoring system and physical examination and hormonal lab tests) and no history of other disease with an appearance like hirsutism and do not use any other drugs, after signing a written consent are divided randomly in 2 groups; treatment group (with finasteride) and control group (with placebo). The number of patients in each group is 15. The patients are visited a week after usage of the drug and then every one month and a photograph is taken from the site that the formulation is used on it and the amount of response to the treatment and satisfactory of the physician and the patient is recorded. After 6 months the results are compared .If possible at the end of the study (after 6 months) a blood sample for detecting the drug is achieved from the patients in the treatment (interventional) group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013072214106N1
Registration date:2013-09-11, 1392/06/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-11, 1392/06/20
Registrant information
Name
Reza Tahvilian
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6482
Email address
rtahvilian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying and preparig semi-solid formulations of Finastride and Clinical evaluation of optimal form in the treatment of Hirsutism
Public title
Effect of topical application of finasteride in the treatment of hirsutism in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: women after puberty that have hirsutism based on Ferriman-Gallwey scoring system.
Exclusion criteria:
1. The patient uses any other drugs.
2. History of other disease with an appearance like hirsutism.
3. The patient is will less to continue participating in this study.
Age
From 18 years old to 48 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Science
Street address
Shahid Beheshti Street, Kermanshah
City
Kermanshah
Postal code
Approval date
2013-07-10, 1392/04/19
Ethics committee reference number
14955
Health conditions studied
1
Description of health condition studied
Hirsutism
ICD-10 code
L68.0
ICD-10 code description
Hirsutism
Primary outcomes
1
Description
Severity of hirsutism
Timepoint
First day - 1 week later- every one month untill 6 months later
Method of measurement
Ferriman-Gullway score
Secondary outcomes
1
Description
Acne
Timepoint
First day - 6 months later
Method of measurement
Based on physician's discription
Intervention groups
1
Description
Interventional group: Finasteride, 0.25% topical gel, twice daily for six months
Category
Treatment - Drugs
2
Description
Control group: placebo, placebo topical gel, twice daily for six months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Haj Daee Clinic
Full name of responsible person
Dr. Ali Ebrahimi
Street address
Kermanshah - Haj Daee Clinic
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah Univesity of Medical Science,Research vice-presidency
Full name of responsible person
Dr. Farid Najafi
Street address
Kermanshah, Shahid Beheshti Street
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah Univesity of Medical Science,Research vice-presidency
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
Kermanshah University of Medical Sciences
Full name of responsible person
Sahar Masoud
Position
student of Pharmacy
Other areas of specialty/work
Street address
Kermanshah - Shahid Beheshti Street
City
Kermanshah
Postal code
Phone
+98 83 1835 9646
Fax
Email
saharmasoud@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Tahvilian
Position
Ph.D. in Pharmaceutics
Other areas of specialty/work
Street address
Kermanshah - Shahid Beheshti Street
City
Kermanshah
Postal code
Phone
+98 83 1427 6489
Fax
Email
rtahvilian@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sahar Masoud
Position
student of Pharmacy
Other areas of specialty/work
Street address
Kermanshah - Shahid Beheshti Street
City
Kermanshah
Postal code
Phone
+98 83 1835 9646
Fax
Email
saharmasoud@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)