Evaluating the efficacy of Losartan ointment (an Angiotensin II Type I Receptor) in wound healing and preventing hypertrophic scars and keloids formation (useful in the injured military soldiers )
Evaluating the efficacy of losartan ointment (an Angiotensin II Type I Receptor) in wound healing and preventing hypertrophic scars and keloids formation
Design
a single-center double-blind, randomized, placebo-controlled, parallel-group, Randomised with block randomization method clinical trial, on 24 patients with acute surgical scar
Settings and conduct
The ointments will be placed in the same shape and colored bottles and a specific code will be attached to the bottles. Each time we will ask the patients to use each placebo and Losartan cream in a specific place twice a day for six months. Neither patient nor doctors or health care staff will know which cream (Placebo or drug) is administered in each site.
Participants/Inclusion and exclusion criteria
patient with more than 10 centimeters scar length and aged between 18 to 50 years old will included.
Patients with irregular ointments consume or those who are pregnant, consume antihypertensive drugs or have a history of cancer, allergy, and bleeding or discharge at scar site will be excluded.
Intervention groups
A part of the scar treated with Losartan ointment.
A part of the scare treated with Placebo ointment.
Main outcome variables
Vancouver Scar Scale assesses 4 variables, vascularity, height/thickness, pliability, and pigmentation will be use rate the scar change, and the Visual Analogue Scale will be used for itching.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201205049601N1
Registration date:2020-12-16, 1399/09/26
Registration timing:prospective
Last update:2020-12-16, 1399/09/26
Update count:0
Registration date
2020-12-16, 1399/09/26
Registrant information
Name
Behzad Khodai
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7769 4460
Email address
khodaibehzad@alimnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-03, 1399/11/15
Expected recruitment end date
2022-02-04, 1400/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of Losartan ointment (an Angiotensin II Type I Receptor) in wound healing and preventing hypertrophic scars and keloids formation (useful in the injured military soldiers )
Public title
Evaluating the efficacy of Losartan ointment in wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient’s scar length should be more than 10 centimeter, or they should have several scars with total length of 10 centimeter.
The patient’s age should be between 18 to 50 years old.
Exclusion criteria:
The patients who did not regularly consume ointments will be excluded.
The patients who are pregnant, consume antihypertensive drugs, or have history of cancer, allergy and bleeding or discharge at scar site will be excluded.
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
2
The scars in different parts of the body for example left or right side of the abdomen or first 5 centemeter as a sample and second 5 centemeter of the scar as another sampel.
Randomization (investigator's opinion)
Randomized
Randomization description
In this double-blinded, parallel clinical trial, the block randomization method will be used using 4,6, and 8 block sizes. First, the patient's scar will be categorized into two groups (left and right). Then one side, for example, the right side, will be considered as a reference site. The intended treatment (Losartan ointment) will then be allocated using the block randomization method to the reference site. For example, if treatment (Losartan ointment) is allocated to the right side, the placebo will be automatically allocated to the left side. The following website will be used for generating a list of randomized interventions: https://www.sealedenvelope.com/simple-randomiser/v1/lists
The allocation will be concealed using the sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Each Losartan and placebo ointment will be defined with a specific code. The ointments will be placed in the same shape, and colored bottles, and the specific code will be attached to the bottles. Each time we will ask the patients to use each placebo and Losartan cream in a specific place twice a day for six months. Neither patient, caregivers, including nurses, nor doctors will know which cream (Placebo or drug) is administered in each site. The data will be collected using the Vancouver scar scale by doctors who had been blind to which drug is administered in each site. The corresponding researcher, the person who analysis the data and prepare the first draft of the article will not be blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
AJA University of Medical Sciences
Street address
AJA University of Medical Sciences, Etemad Zadeh St. ,Fatemi Ave. ,Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2020-11-15, 1399/08/25
Ethics committee reference number
IR.AJAUMS.REC.1399.166
Health conditions studied
1
Description of health condition studied
wound healing and preventing hypertrophic scars and keloids formation
ICD-10 code
L91.0
ICD-10 code description
Hypertrophic scar
Primary outcomes
1
Description
Scare assessment, Vancouver Scar Scale (VSS) assesses 4 variables: vascularity, height/thickness, pliability, and pigmentation. The overall score is between 0 to 13.
Timepoint
Three and six months after ointment administration
Method of measurement
The evaluators are doctors who will use VSS or Vancouver scar scale to rate the scar change. Vancouver Scar Scale (VSS) assesses 4 variables: vascularity, height/thickness, pliability, and pigmentation. The overall score is between 0 to 13
Secondary outcomes
1
Description
Itching is an irritating sensation of the skin which will be measured by the Visual Analogue Scale.
Timepoint
Three and six months after ointment administration
Method of measurement
The evaluators are doctors and will be measured by the Visual Analogue Scale.
Intervention groups
1
Description
Intervention group: First a patient's scar will be categorized into two similar groups (Left and side). A Part of the scar selected randomly will be treated with Losartan ointment. The 5% Losartan ointment will be defined with a specific code. The ointment is going to be made by dissolving Losartan powder in a solvent including propanol and water and then mixed with eucerin to reach 100 mg weight. The patients will be asked to use 5% Losartan ointment tropically in the specified places twice a day every 12 hours for six continuous months.
Category
Treatment - Drugs
2
Description
Control group: First a patient's scar will be categorized into two similar groups (Left and side). A Part of the scar selected randomly will be treated with Placebo. The placebo consists of the solvent, including propranolol and water, and then mix it with eucerin to reach 100 mg weight and will not contain Losartan powder. The patients will be asked to use a 5% Losartan ointment tropically in the specified places twice a day every 12hours for six continuous months.