Comparison of the effect of intralesional injection of triamcinolone acetonide with the simultaneous combination of triamcinolone acetonide and 5-fluoracil in the treatment of hypertrophic scars
Comparison of the effect of intralesional injection of triamcinolone acetonide with the simultaneous combination of triamcinolone acetonide and 5-fluoracil in the treatment of hypertrophic scars
Design
This is a randomized, and non-blinded clinical trial with a parallel design. In this randomized study, 40 eligible patients will be included in the study. A table of random numbers is used for randomization, and the participants are assigned to two intervention groups.
Settings and conduct
This study, which will be conducted in the Haj Dayi Clinic of Kermanshah, is nonblinded. The two studied groups will be matched in terms of age, gender, and duration of the lesion.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent
Exclusion criteria: Patients under treatment for the last 6 months; Pregnant patients or those planning to become pregnant; Lactating women; Chronic kidney disease patients or those with any abnormal changes in CBC or liver function tests
Intervention groups
In the first intervention group, 20 mg of triamcinolone acetonide (manufactured by Alborz Company) will be used inside the lesion once every four weeks for 6 treatment sessions (that is, injection of 50% of triamcinolone acetonide (40 mg).In the second intervention group, 50% triamcinolone acetonide injection (40 mg) and 50% 5-Fluoracil (manufactured by Alborz company) (50 mg) will be used. Finally, the combination of 20 mg of triamcinolone acetonide with 25 mg of 5-Fluoracil is prepared for injection and is injected to patients every 4 weeks.
Main outcome variables
the intensity of itching of the lesion; the intensity of redness of the lesion; Length, width, and height of the lesion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N189
Registration date:2022-10-25, 1401/08/03
Registration timing:prospective
Last update:2022-10-25, 1401/08/03
Update count:0
Registration date
2022-10-25, 1401/08/03
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-16, 1401/08/25
Expected recruitment end date
2023-01-05, 1401/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intralesional injection of triamcinolone acetonide with the simultaneous combination of triamcinolone acetonide and 5-fluoracil in the treatment of hypertrophic scars
Public title
Comparison of the effect of intralesional injection of triamcinolone acetonide with the simultaneous combination of triamcinolone acetonide and 5-fluoracil
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Exclusion criteria:
Patients under treatment for the last 6 months
Pregnant patients or those planning to become pregnant
Lactating women
Chronic kidney disease patients or those with any abnormal changes in CBC or liver function tests
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random number table, patients are divided into two groups of 20. Each patient is assigned a 4-digit code based on the random number table; based on the right number of patients' codes, the patients are divided into two groups. Patients whose last digit is 2, 4, 6, and 8 will be assigned to the intervention group, and patients whose last digit is 1,3,5, and 7 will be assigned to the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2022-06-26, 1401/04/05
Ethics committee reference number
IR.KUMS.MED.REC.1401.068
Health conditions studied
1
Description of health condition studied
Hypertrophic scar
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intensity of itching of the lesion
Timepoint
First, fourth and sixth week
Method of measurement
Based on examination and questioning of the patient
2
Description
Redness intensity of the lesion
Timepoint
First, fourth and sixth week
Method of measurement
Based on examination
3
Description
Length, width and height of the lesion
Timepoint
First, fourth and sixth week
Method of measurement
Based on examination
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, 20 mg of triamcinolone acetonide (manufactured by Alborz Company) will be used inside the lesion once every four weeks for 6 treatment sessions (that is, injection of 50% of triamcinolone acetonide (40 mg).
Category
Treatment - Drugs
2
Description
In the second intervention group, 50% triamcinolone acetonide injection (40 mg) and 50% 5-Fluoracil (manufactured by Alborz company) (50 mg) will be used. Finally, the combination of 20 mg of triamcinolone acetonide in 25 mg of 5-Fluoracil is prepared for injection and is injected to patients every 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Haji Dayi skin clinic
Full name of responsible person
Abdolhamid Ebrahimi
Street address
Golestan Crossroads
City
Kermanshah
Province
Kermanshah
Postal code
6714647147
Phone
+98 83 3845 3486
Email
pamiebi1377@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Cyrus Jalili
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
cjalili@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Abdolhamid Ebrahimi
Position
Resident of Skin
Latest degree
Medical doctor
Other areas of specialty/work
Skin
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
pamiebi1377@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hossein Kavosi
Position
Member of the academic staff of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Skin
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
hkawosi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Abdolhamid Ebrahimi
Position
Resident of Skin
Latest degree
Medical doctor
Other areas of specialty/work
Skin
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
pamiebi1377@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD