The aim of this study was to compare the treatment of acne with Metformin compared with Isotretinoin.
Design
In this clinical trial study, 70 patients with acne who are referred to Rasoul- E Akram hospital are selected. Participants were randomly divided into two control and intervention groups. Outcome assessor and data analyzer has been blinded
Settings and conduct
This study will be carried out at Rasuol-E Akram Hospital of Iran University of Medical Sciences with the aim of acne treatment. Outcome assessor and data analyzer will be blinded of the type of intervention prescribed for each individual.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Start acne from adolescence and continue acne until the age of 25, start acne from adolescence and continue after 25 years, start acne after 25 years. Exclusion criteria: History of taking Metformin or Isotretinoin and history of chronic diseases of kidney, liver or heart
Intervention groups
The intervention group will take Metformin 500 mg twice daily for 6 months and the control group will take oral Isotretinoin 20 mg every other day for 6 months.
Main outcome variables
Investigating the changes of acne severity is the main consequences of the study.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140624018210N8
Registration date:2018-10-21, 1397/07/29
Registration timing:registered_while_recruiting
Last update:2018-10-21, 1397/07/29
Update count:0
Registration date
2018-10-21, 1397/07/29
Registrant information
Name
Elham Behrangi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 2040
Email address
behrangi.e@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-04, 1397/02/14
Expected recruitment end date
2019-04-03, 1398/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of Metformin with Isotretinoin in the treatment of patient with acne or delayed acne
Public title
Evaluating the efficacy of Metformin with Isotretinoin in the treatment of acne
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Start acne from adolescence and continue acne until the age of 25
Start acne from adolescence and continue after 25 years
Start acne after 25 years
Exclusion criteria:
History of taking Metformin or Isotretinoin
History of chronic diseases of kidney, liver or heart
Age
From 25 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method is used. This method increases the probability that each arm will contain an equal number of individuals by sequencing participant assignments by each block.The randomization unit is individual and randomization's tool is a statistical software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the outcome assessor and participants have been blinded. The outcome assessor is people who are responsible for gathering data and outcome variables and does not know which participant received which drug.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Siences
Street address
Iran University of Medical Siences, Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-09-12, 1397/06/21
Ethics committee reference number
IR.IUMS.FMD.REC.1397.048
Health conditions studied
1
Description of health condition studied
Acne
ICD-10 code
L70
ICD-10 code description
Acne
Primary outcomes
1
Description
Changes of acne severity
Timepoint
1, 3 and 6 months after intervention
Method of measurement
Clinical examination
Secondary outcomes
1
Description
Fasting blood sugar
Timepoint
Before starting the intervention and 6 months after the intervention
Method of measurement
Blood test
2
Description
Cholesterol
Timepoint
Before starting the intervention and 6 months after the intervention
Method of measurement
Blood test
3
Description
Triglyceride
Timepoint
Before starting the intervention and 6 months after the intervention
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: Metformin with a dose of 500 mg twice a day for 6 months will be taken along with other prescribed medicines.
Category
Treatment - Drugs
2
Description
Control group: Oral isotretinoin will be taken a dose of 20 mg twice a day for 6 months along with other prescribed medicines.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul- E Akram Hospital
Full name of responsible person
Somayeh Sadeghi
Street address
Rasoul- E Akram Hospital, Niayesh St, Sattarkhan Ave
City
Tehran
Province
Tehran
Postal code
1313114456
Phone
+98 21 6435 2378
Email
asomayeh1394@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakouti
Street address
Iran University of Medical Sciences, Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8860 2230
Email
Malakouti.k@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elham Behrangi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Rasoul- E Akram Hospital, Niayesh St, Sattarkhan Ave