Objectives: To assess the effect of omega-3 on acne. Design: A triple blinded randomized clinical trial. Setting and conduct: All eligible patients with acne vulgaris who will refer to clinic of Farshchian Hospital will be enrolled in to the trial. Inclusion criteria: having moderate to severe facial acne vulgaris. Exclusion criteria: (a) being immunodeficient; (b) contraindication of acne treatment; (c) using medications which have interaction with omega-3. Intervention: Oral doxycycline 100 mg daily plus oral 1000 mg omega-3, daily, for 12 weeks. Control: Oral doxycycline 100 mg daily plus oral placebo including starch, daily, for 12 weeks Primary outcome: The severity of acne at the end of sixth and twelfth weeks based on global acne grading system.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013091714690N1
Registration date:2014-02-26, 1392/12/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-26, 1392/12/07
Registrant information
Name
Hassan Faghani
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1835 4500
Email address
h.faghani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of omega-3 versus placebo on acne in patients aged 13-50 years: a triple blinded randomized clinical trial
Public title
The effect of omega-3 versus placebo on acne in patients aged 13-50 years
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having moderate to severe facial acne vulgaris.
Exclusion criteria: (a) being immunodeficient; (b) contraindication of acne treatment; (c) using medications which have interaction with omega-3.
Age
From 13 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: 30 envelopes containing the letters A (intervention group) and 30 envelopes containing the letters B (control group) will be numbered from one to 60 based on a table of random numbers. Then, the patients will be assigned to each envelope in order.
Blinding: The patients will receive either Omega-3 capsule or placebo (starch) capsule with the same shape but different content. Thus, they will not aware of the intervention. In addition, the examiner, who will assess the results of intervention, and the analyzer of the data will not aware of the type of treatment received by the patients. Thus, the trial will be run as triple blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2012-08-18, 1391/05/28
Ethics committee reference number
P/D/16/35/9/1842
Health conditions studied
1
Description of health condition studied
Acne
ICD-10 code
L70
ICD-10 code description
Acne
Primary outcomes
1
Description
The severity of acne
Timepoint
at the end of sixth and twelfth weeks
Method of measurement
based on global acne grading system
Secondary outcomes
empty
Intervention groups
1
Description
Oral doxycycline 100 mg daily plus oral 1000 mg omega-3, daily, for 12 weeks.
Category
Treatment - Drugs
2
Description
Oral doxycycline 100 mg daily plus oral placebo including starch, daily, for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Dr Hassan Faghani
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
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
Department of Dermatology
Full name of responsible person
Dr Hassan Faghani
Position
Resident of Dermatology
Other areas of specialty/work
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
+98 81 1838 0717
Fax
Email
dr.faghani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Dermatology
Full name of responsible person
Dr Hassan Faghani
Position
Resident of Dermatology
Other areas of specialty/work
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
+98 81 1838 0717
Fax
Email
dr.faghani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Dermatology
Full name of responsible person
Dr Hassan Faghani
Position
Resident of Dermatology
Other areas of specialty/work
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
+98 81 1838 0090
Fax
Email
dr.faghani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)