This clinical trial study was conducted on melassma female patients with moderate acne who lacked hepatic disease and were not pregnant or breastfeeding and didn't receive OCPs or antiandrogenic drugs. Sample size was estimated to be 30 for each group. Patient allocated randomly to study groups. Diagnosis is made by one dermatologist and further data collection, evaluation and counting lesions was done by another person. Prescriptions were delivered in sealed envelopes by a nurse staff. Trial group received 250 mg daily flutamide and control group received 100 mg daily doxyciline. Both groups received topical clindamicine. CBC tests were done for trial group before treatment, one month and 4 months after treatment. Evaluation of the patient’s condition were done every two months .To get this result numbers of lesions were counted , and sebum reduction was evaluated by Mexameter, and finally patients satisfaction was evaluated by questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905044310N3
Registration date:2010-07-26, 1389/05/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-07-26, 1389/05/04
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
Expected recruitment start date
2007-02-14, 1385/11/25
Expected recruitment end date
2008-07-15, 1387/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of terapeutic effects of Flutamide and Doxicyclin on moderate acne among females
Public title
Oral flutamide effects on female acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Female sex
2- Moderate acne
3- Age above 16
4- Having melassma
Exclusion criteria
1- Pregnancy and breastfeeding
2- Hepatic disease
3- Taking OCPs or antiandrogenic drugs
Age
No age limit
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)
Not 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
Daneshgah street, Ardebil medical university
City
Ardebil
Postal code
Approval date
empty
Ethics committee reference number
Number-3
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
Acne lesion improvment
Timepoint
Every 2 months
Method of measurement
Count of the lesions
Secondary outcomes
1
Description
Side effects of drug
Timepoint
2 months
Method of measurement
Clinical examination
2
Description
Reduction of sebum
Timepoint
2 months
Method of measurement
Mexameter
3
Description
patient satisfaction
Timepoint
2 Months
Method of measurement
questionnaire
Intervention groups
1
Description
Flutamide250 mg daily + topical clindamicin 1% for six months
Category
Treatment - Drugs
2
Description
Doxicyclin 100 mg daily + topical clindamicin 1% for six months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Babak dermatology clinic
Full name of responsible person
Hasan Edalatkhah
Street address
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 University of medical sciences
Full name of responsible person
Hasan Edalatkhah
Position
MD, Specialty degree in dermatology
Other areas of specialty/work
Street address
Emam khomayni hospital, Ardebil
City
Ardebil
Postal code
Phone
+98 45 1225 1401
Fax
Email
h.edalatkhah@arums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardebil University of medical sciences
Full name of responsible person
Hasan Edalatkhah
Position
MD, Specialty degree in dermatology
Other areas of specialty/work
Street address
Emam khomayni hospital, Ardebil
City
Ardebil
Postal code
Phone
+98 45 1225 1401
Fax
Email
h.edalatkhah@arums.ac.ir; h.edalatkhah@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardebil university of medical sciences
Full name of responsible person
Rasoul Lotfollahzadeh
Position
Research officer
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)