Objectives: To assess the effect of topical versus oral simvastatin as adjuvant therapy for treatment of acne vulgaris.
Design: a randomized clinical trial.
Setting and conduct: The eligible patients with acne vulgaris who will refer to Sina Hospital during the study period will be enrolled into the trial.
Inclusion criteria: age of 18 to 65 years; moderate to severe acne vulgaris based on GAGS criteria for 6 months.
Exclusion criteria: pregnancy; breastfeeding; liver disorder; renal disorder; using drug for acne during the last month.
Intervention group 1: Oral azithromycin 250 mg daily for 8 weeks plus oral simvastatin 40 mg daily for 8 weeks plus topical placebo daily for 8 weeks.
Intervention group 2: Oral azithromycin 250 mg daily for 8 weeks plus oral placebo daily for 8 weeks plus topical simvastatin daily for 8 weeks.
Control group: Oral azithromycin 250 mg daily for 8 weeks plus oral placebo daily for 8 weeks plus topical placebo daily for 8 weeks.
Primary outcome: Clinical sign of acne vulgaris before and 8 weeks after treatment using GAGS criteria.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201612049014N135
Registration date:2016-12-07, 1395/09/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-12-07, 1395/09/17
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of topical versus oral simvastatin as adjuvant therapy for treatment of patients with acne vulgaris: a randomized clinical trial
Public title
Effect of topical versus oral simvastatin as adjuvant therapy for treatment of patients with acne vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of 18 to 65 years; moderate to severe acne vulgaris based on GAGS criteria for 6 months.
Exclusion criteria: pregnancy; breastfeeding; liver disorder; renal disorder; using drug for acne during the last month.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
69
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-11-18, 1395/08/28
Ethics committee reference number
IR.UMSHA.REC.1395.371
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
Clinical sign of acne vulgaris
Timepoint
before and 8 weeks after treatment
Method of measurement
using GAGS criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Oral azithromycin 250 mg daily for 8 weeks plus oral simvastatin 40 mg daily for 8 weeks plus topical placebo daily for 8 weeks.
Category
Treatment - Drugs
2
Description
Intervention group 2: Oral azithromycin 250 mg daily for 8 weeks plus oral placebo daily for 8 weeks plus topical simvastatin daily for 8 weeks.
Category
Treatment - Drugs
3
Description
Control group: Oral azithromycin 250 mg daily for 8 weeks plus oral placebo daily for 8 weeks plus topical placebo daily for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Anahita Ahmadvand
Street address
Sina 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
School of Pharmacy
Full name of responsible person
Anahita Ahmadvand
Position
Student of Pharmacology
Other areas of specialty/work
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
aahmadvand.phun@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Pharmacy
Full name of responsible person
Dr Maryam Mehrpooya
Position
Pharmacologist
Other areas of specialty/work
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
m_mehrpooya2003@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)