We designed this study to evaluate the effect of Ώ-3 on moderate acne-Vulgaris patients’ candidate for systemic therapy.
Double blind randomized clinical trialson 60 patients in 2 groups (intervention & control) are selected. Patients have indication of systemic therapy based on bloke randomization included. Patients were excluded if had: diabetes mellitus; hypertension; significant pulmonary, hepatic or renal disease; typical angina or myocardial infarction; use of antihypertensive, oral hypoglycemic or lipid lowering agent or anticoagulant drug; glucocorticoids equivalent to greater than 10 mg Prednisolone daily; all pregnant or lactating women. All subjects were asked to stop all vitamin and mineral supplements, including fish oils, at least 6 weeks before commencing the study. The patients in Intervention group were adminitered to take Ώ-3 Capsule (2 capsule daily) in addition to Doxycyclin Capsule (200 mg daily) for a total of 4 weeks. Randomization occurred off-site by an independent body. The Control group was Doxycyclin Capsule (200 mg daily).Each Ώ-3 Capsule contain 1 gram fish oil (180 mg EPA & 120 mg DHA).Patients were assessed at week 4.All clinical assessments were Performed by the same nurse who was blinded to Study medication.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012080110471N1
Registration date:2012-08-31, 1391/06/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-31, 1391/06/10
Registrant information
Name
Milad Masaeli
Name of organization / entity
Kurdistan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3356 5240
Email address
drmilmas@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdestan University of Medical Science
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of omega – 3 in treatment of Acne – Vulgaris: a DOUBLE BLIND STUDY
Public title
The efficacy of omega – 3 in treatment of Acne – Vulgaris: a DOUBLE BLIND STUDY
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: acne- vulgaris patients have indication of systemic therapy treatment
exclusion criteria:diabetes mellitus; hypertension ; significant pulmonary, hepatic or renal disease ; typical angina or myocardial infarction; use of antihypertensive, oral hypoglycemic or lipid lowering agent or anticoagulant drug; glucocorticoids equivalent to greater than 10 mg Prednisolone daily; all pregnant or lactating women.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Kurdistan Local Research Ethics Committee
Street address
Kurdestan University of Medical Science,Sanandaj,Iran
City
Sanandaj
Postal code
66177-13446
Approval date
2010-07-19, 1389/04/28
Ethics committee reference number
پ/14/پ/49963
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
improvment skin lesion such as comedone,papules,pustules,nodules
Timepoint
1 month
Method of measurement
with count the facial lesion
Secondary outcomes
1
Description
improvement skin lesion such as comedone, papules, pustules, nodules
Timepoint
1 month
Method of measurement
with count the facial lesion
Intervention groups
1
Description
The patients in Intervention group were administered to take Ώ-3 Capsule (2 capsule daily) in addition to Doxycyclin Capsule (200 mg daily) plus topical antibactrial (Erythromycin Solution for4%,twice a day) for total of 4 weeks.Each Ώ-3 Capsule contains 1 gram fish oil (180 mg EPA & 120 mg DHA).
Category
Treatment - Drugs
2
Description
For control group was administered Doxycyclin 200 mg daily and topical antibacterial (Erythromycin Solution 4% twice a day) for total 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Hair & Dermatology oF Dr.Hassanzadeh
Full name of responsible person
Dr.Seyyed Jamal Adin Hassanzadeh
Street address
Jina Doctors building,Keshavarz street,Azadi square
City
Sananadaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdestan University of Medical Science
Full name of responsible person
Fardin Gharibi
Street address
Kurdestan University of Medical Science, Pasdaran Ave, Azadi Square,
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdestan University of Medical Science
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
Kurdestan University of Medical Science
Full name of responsible person
Milad Masaeli
Position
Medical Student
Other areas of specialty/work
Street address
Kurdestan University of Medical Science, Pasdaran Ave, Azadi Square