This study was a interventional study,The aim was study of combination effect of ciprotrone compound & flutamide in females with severe acne.Inclusion criteria was Females with severe acne and Exclusion criteria were: pregnancy; breastfeeding; liver disease; receiving anti acne drugs; OCP & spironolacton in last 2 months.population study of group were females with severe acne.sample size was 30 person. The study period was 6 months.At this period, patients were received 125mg/day flutamide combined with cyproteron compound one pill/day ,21days a month and 1% topical clindamicine Twice a day.the primary outcome was reduction in acne counting that conducted with counting acne lesions and measurement of acne severity index.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201302164310N8
Registration date:2014-04-28, 1393/02/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-28, 1393/02/08
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
Islamic Azad University of Ardabil
Expected recruitment start date
2011-01-20, 1389/10/30
Expected recruitment end date
2012-01-20, 1390/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Cyproterone Compound Combined with flutamide in females severe acne
Public title
Effects of Cyproterone Compound Combined with flutamide in females severe acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: females that had severe acne.
Exclusion criteria: pregnancy; breastfeeding; liver disease; receiving anti acne drugs; OCP & spironolacton in last 2 months.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Ardabil University of Medical Science
Street address
Ardabil University of Medical Science,Daneshgah st,Adabil
City
Ardabil
Postal code
04515518939
Approval date
2008-05-10, 1387/02/21
Ethics committee reference number
arums.re.1385.23
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
decrease in acne leasions
Timepoint
onset of study & 60th,120th,180th of study
Method of measurement
lesions counting
Secondary outcomes
1
Description
Patients`satisfaction
Timepoint
Every two months
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention was therapiutic by drug.The stdy had only intervention group.Patient were recieved 125mg/day oral flutamide tab dual with cyproteron compound pills, one tab/day, 21 days a month and 1% clindamicine twice daily.