Study population in this clinical trial study were females with acne who were not pregnant or lactating, lacked hepatic disease and didn’t use OCPs or anti androgenic drugs. Sample size was calculated to be 30 for each group. Six months long treatment regimen was used. Improvement of acne and decrease in dermal fat was assessed every two months. Diagnosis was made by a dermatologist and assessments were made by someone else in dermatology specialty clinic. Patients in the intervention group received oral Flutamide 250 mg daily and control (standard treatment) group received Cyprtoterone compound one tablet daily (21 days over one month). Both groups received topical Clindamicine complementary treatment twice daily.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904134310N1
Registration date:2007-02-20, 1385/12/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2007-02-20, 1385/12/01
Registrant information
Name
Hassan Adalatkhah
Name of organization / entity
Ardebil University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 308 6490
Email address
h.edalatkhah@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
"Ardebil medical university", Deputy for research
Expected recruitment start date
2007-02-20, 1385/12/01
Expected recruitment end date
2008-02-20, 1386/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapiotic effects of oral Flutamide and Cyproteron compound on female moderate acne
Public title
Therapiotic effects of flutamide on female acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion:
1-Women who having moderate acne
2-age>16
Exclusion:
1-Pregnancy
2- hepatic diseases
3- Using OCPs and androgenic drugs
Age
From 16 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardebil Medical University
Street address
Deputy of research, Daneshgah street, Ardebil
City
Ardebil
Postal code
56189/53141
Approval date
empty
Ethics committee reference number
number-1
Health conditions studied
1
Description of health condition studied
Acne vulgaris
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
Primary outcomes
1
Description
Count of acne lesions
Timepoint
2 months
Method of measurement
Counting the lesions
Secondary outcomes
1
Description
Reduction of sebum
Timepoint
2 months
Method of measurement
Mexameter
2
Description
Side effects of drug
Timepoint
2 months
Method of measurement
Clinical examination
3
Description
Degree of resolution of acne lesions
Timepoint
2 months
Method of measurement
Counting of acne lesion
Intervention groups
1
Description
Flutamide 250 mg daily +topical clindamicin 1% for six months
Category
Treatment - Drugs
2
Description
Cyproteron compound+topical clindamicin 1% for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Babak dermatology clinic
Full name of responsible person
Edalatkhah
Street address
Sarcheshmeh circus, Ardebil
City
Ardebil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardebil Medical University
Full name of responsible person
Dr Mehrdad Mirzarahimi
Street address
Deputy of research, Ardebil medical university, Daneshgah street, Ardebil
City
Ardebil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardebil Medical University
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
Ardebil medical University
Full name of responsible person
Dr. Mohsen Arzanlou
Position
Research deputy manager -PhD
Other areas of specialty/work
Street address
Ardebil medical University, Raheh daneshgah
City
Ardebil
Postal code
Phone
+98 45 1551 0054
Fax
Email
m.arzanlou@arums.ac.ir
Web page address
www.arums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardebil Medical University
Full name of responsible person
Dr Hasan Edalatkhah
Position
Dermatologist
Other areas of specialty/work
Street address
Ardebil Medical University, Raheh daneshgah
City
Ardebil
Postal code
Phone
+98 914 308 6490
Fax
Email
h.edalatkhah@arums.ac.ir; h.edalatkhah@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Rasoul lotfollahzadeh
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 45 1551 0061
Fax
Email
Web page address
www.arums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)