Comparasion therapiutic effects of oral Erythromycin along with low dose oral Isotretinoin and oral Erythromycin and low dose Flutamide versus Doxycyclin in female severe acne vulgaris .
This research was a single blind and randomized study. The aim was comparison of therapeutic effects of oral Erythromycin along with low dose oral Isotretinoin and oral Erythromycin and low dose Flutamide versus Doxycyclin in female severe acne vulgaris. Inclusion criterion was females with severe acne & Exclusion criteria were: breastfeeding; pregnancy; tending to pregnancy; liver disease; hyperlipidemia; receiving anti acne drugs; contraceptive's; spironolacton in last 2 month. Population study of group was females with severe acne. Sample size was 90 (30 per group).The first intervention group received Erythromycin 400mg per 12 hours along with oral Isotertinoin 20 ml in 2 alternate days. The second intervention group received Erythromycin 400 mg per 12 hours along with Flutamide 65 mg per day. Control group, received Doxycyclin capsules 100 mg per 12 hours. Primary outcome was reduction of acne lesions count. That conducted with acne lesions counting and measurement of acne severity index.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104094310N6
Registration date:2014-04-19, 1393/01/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-19, 1393/01/30
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
Ardabil University of Medical Sciences
Expected recruitment start date
2013-09-20, 1392/06/29
Expected recruitment end date
2014-02-18, 1392/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparasion therapiutic effects of oral Erythromycin along with low dose oral Isotretinoin and oral Erythromycin and low dose Flutamide versus Doxycyclin in female severe acne vulgaris .
Public title
Comparasion of therapiutic effects of oral Erythromycin along with low dose oral Isotretinoin and oral Erythromycin and low dose Flutamide versus Doxycyclin in female severe acne vulgaris.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: females with severe acne.
Exclusion criteria: pregnancy; breastfeeding; liver disease; hyperlipidemia; receiving anti acne drugs; OCP pills; 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:
90
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
Ardabil University of Medical Science
Street address
Daneshgah St. , Ardabil
City
Ardabil
Postal code
Approval date
2013-09-15, 1392/06/24
Ethics committee reference number
arums.rec,92.28
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 of acne leasions
Timepoint
Onset of study & 30th & 60th day's of study
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
Control group received 100 ml oral daxycycline every 12 hours during 2 mounths.
Category
Treatment - Drugs
2
Description
First intervention group(the group that received oral eritromycin and oral isotretinoin ),this group received 800 ml of oral eritromycin (400 ml/BID) and 20 ml oral isotretinoin every 48 hours during 2 mounths.
Category
Treatment - Drugs
3
Description
Second intervention group received 800 ml oral eritromycin a day (400 ml/BID) and 65 ml oral flutamid a day during 2 mounth.