This study was a clinical intervention and aim of the study was combination effects of doxycycline and flutamide in females with severe acne. Inclusion criterion was females with severe acne and the exclusion criteria were consist of: females with liver disease; pregnancy and breastfeeding; received anti acne drugs, OCP, spironolacton. The study population included women with severe acne. Sample size was 30. The study period was 6 months. The patients were received Flutamide 125mg/day dual with Doxycycline 100mg/day. At the beginning of treatment and two months after treatment, CBC and liver function tests were performed. Patient assessed every two months. To assess recovery, number lesions of acne counting, acne severity index was used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104084310N5
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
2013-04-19, 1392/01/30
Expected recruitment end date
2014-01-20, 1392/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of combined treatment of Doxycycline dual with flutamide in female severe acne
Public title
Effects of combined treatment of Doxycycline dual with flutamide in female severe acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: females with severe acne.
Exclusion criteria: liver disease; pregnancy and breastfeeding; receiving anti acne drug's, OCP and spironolacton in last 2 months.
Age
No age limit
Gender
Female
Phase
3
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
5618953141
Approval date
2007-03-07, 1385/12/16
Ethics committee reference number
arums.re.1385.22
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
Every two months
Method of measurement
lesions counting
Secondary outcomes
1
Description
Patients`satisfaction
Timepoint
Every two months
Method of measurement
Questionnaire
Intervention groups
1
Description
Oral flutamide 125 mg/day dual with Doxycycline 100 mg/day and topical clindamicine 1% for six months