To assess the effect of topical ointment losartan versus placebo ointment on improvement of surgical scar
Design
This is a double-blind randomized clinical trial with control group, phase III, in which eligible patients will be randomly assigned through the stratified randomization to the intervention and control groups
Settings and conduct
This study will be performed in the Sina Hospital in Hamadan city on 60 eligible patients with surgical scar. The patients will be randomly assigned to the intervention and control groups through the stratified randomization. This trial will be double-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 70 years
Having a surgical scar
Exclusion criteria:
Pregnancy or breastfeeding
The presence of a wound or infection at the treatment site
Coagulation disorder or immune system disorder
Intervention groups
Intervention group:
Applying losartan topical ointment on the surgical scar twice a day for 3 months
Control group:
Applying placebo topical ointment (eucerin) on the surgical scar twice a day for 3 months
Main outcome variables
Primary outcome:
Improvement of surgical scar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N453
Registration date:2022-12-26, 1401/10/05
Registration timing:prospective
Last update:2022-12-26, 1401/10/05
Update count:0
Registration date
2022-12-26, 1401/10/05
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
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of topical ointment losartan versus placebo ointment on improvement of surgical scar: a double-blind randomized clinical trial
Public title
Effect of topical ointment losartan versus placebo ointment on improvement of surgical scar
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 70 years
Age 18 to 70 years
Exclusion criteria:
Pregnancy or breastfeeding
The presence of a wound or infection at the treatment site
Coagulation disorder or immune system disorder
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of patients to intervention and control groups is done using stratified randomization method. For this purpose, first, patients are classified based on gender, age groups and type of lesion. Then randomization will be done through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind.
Placebo
Used
Assignment
Parallel
Other design features
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 and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-10-29, 1401/08/07
Ethics committee reference number
IR.UMSHA.REC.1401.649
Health conditions studied
1
Description of health condition studied
Surgical scar
ICD-10 code
L90.5
ICD-10 code description
Scar conditions and fibrosis of skin
Primary outcomes
1
Description
Improvement of surgical scar
Timepoint
6 weeks and 3 months after treatment
Method of measurement
Using Vancouver scar scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Applying losartan topical ointment on the surgical scar twice a day for 3 months
Category
Treatment - Drugs
2
Description
Control group: Applying placebo topical ointment (eucerin) on the surgical scar twice a day for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital in Hamadan city
Full name of responsible person
Dr Masoud Aftabi
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
aftabi.masoud@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Masoud Aftabi
Position
Resident of Dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
aftabi.masoud@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Jamshidi
Position
Dermatologist
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
School of Medicine,
Phone
+98 81 3838 0572
Email
m.jamshidi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Professor of Epidemiology
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available