Study population in this clinical trial study were females with triad of : acne, hirsutism and androgenetic alopecia. If you were not pregnant and lactating or planning pregnancy to 9 months with no contraindications with other medications based on the questionnaire were entered into the study. The sample size was calculated for each group of 15 people. 3 months of treatment and patient evaluation are calculated based on the Total Acne lesion Count(TLC) and acne severity index (ASI) for each patient at baseline, three months and one month after the end of treatment, done. Diagnosis was done by a dermatologist, but the form and physical examination the patient was done by someone else in the dermatology clinic. The first group was treated with decuttane - isotretinoin 20 mg daily 1 tablet and the second group Cyproterone compound (Month 21) received. Also, both equally daily, concurrently treated with azithromycin 250 mg capsules three times a week and once a day solution erythromycin 4% and oil-free sunscreen and soap were TCC.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013110315246N1
Registration date:2013-12-14, 1392/09/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-14, 1392/09/23
Registrant information
Name
Kioumars Jamshidi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1777 2134
Email address
kioumars_jamshidi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2012-04-18, 1391/01/30
Expected recruitment end date
2014-02-19, 1392/11/30
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
Acne cure rate in patients Hyperandrogenism with two drugs of Decuttane and CYPROTERONE COMPOUND .
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 14-45 years old; besides acne hirsutism (Ferriman & Gallwey score greater than or equal to 4) and Ludwing grade one or higher female androgenetic alopecia; absence of contraindications to treatment with tablets decuttane and CYPROTERONE COMPOUND based on questionnaire; not wanting to at least 9 months of pregnancy, or breast-feeding; individual patients signed a consent form
Exclusion criteria: drug allergy; pregnancy or lactation; uncooperative patient or patient's consent to continue reading.
Age
From 14 years old to 45 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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences Ethics Committee
Street address
Deputy of research of isfahan university of medical science, hezarjerib street, Isfahan
City
Isfahan
Postal code
Approval date
2012-04-17, 1391/01/29
Ethics committee reference number
291042
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
Improvement of acne vulgaris lesions
Timepoint
Baseline, three months and one month after the end of treatment.
Method of measurement
Indices are calculated based on the Total Acne lesion Count( TLC) and acne severity index (ASI) for each patient
Secondary outcomes
1
Description
Side effects of drug
Timepoint
Every 6 weeks
Method of measurement
clinical evaluation-liver function test and lipid profile
Intervention groups
1
Description
decuttane - isotretinoin 20 mg daily + Azithromycin 250 mg capsules three times a week, erythromycin solution of 4% once a day, oil-free sunscreen and Tcc soap three months
Category
Treatment - Drugs
2
Description
Cyproterone Compound + Azithromycin 250 mg capsules three times a week, erythromycin solution of 4% once a day, oil-free sunscreen and Tcc soap three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital dermatology clinic
Full name of responsible person
Dr. Kioumars Jamshidi
Street address
dermatology group,Alzahra hospital,Isfahan
City
Isfahan
2
Recruitment center
Name of recruitment center
Noor and Aliasghar Hospitals dermatology clinics
Full name of responsible person
Dr. Kioumars Jamshidi
Street address
dermatology group,Alzahra hospital,Isfahan
City
Isfahan
3
Recruitment center
Name of recruitment center
Segighe Tahere Hospital dermatology clinic
Full name of responsible person
Dr. Kioumars Jamshidi
Street address
dermatology group,Alzahra hospital,Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Ebrahim Esfandiari
Street address
Isfahan university of medical science,Hezar jerib street,Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?