Comparison of the efficacy of intralesional bleomycin plus intralesional triamcinolone in the treatment of keloids in the year of 1401in Loghman and Tajrish hospital
Evaluation of the efficacy of keloid treatment by intralesional injection of bleomycin in combination with triamcinolone intralesional injection.
Design
Clinical trial before and after, without control group, with single groups, no blinding, no randomization, phase 2 on 30 patients.
Settings and conduct
In this study, patients with refractory keloid are treated according to the definition of referring outpatient to Loghman and Shohada-ye Tajrish dermatology clinic in Tehran. Drug injection will be repeated every four weeks and up to 6 sessions with a combination of bleomycin and triamcinolone acetonide, and lidocaine with a ratio of 3:3:3. The VSS (Vancouver Scar Scale) scale will be used to evaluate the efficacy of two treatments at the beginning of the study and the end of the treatment.
Participants/Inclusion and exclusion criteria
Patients between the ages of 18 and 60 with refractory keloid lesions referred to the dermatology clinic of Loghman and Shohada-e-Tajrish hospitals in 1401-1402 will be included in the study; Exclusion criteria: dissatisfaction with the study, sensitivity to bleomycin, pregnant or lactating women.
Intervention groups
treatment of refractory keloid by intralesional injection of bleomycin in combination with triamcinolone intralesional injection.
Main outcome variables
Pigmentation of keloid lesions; pliability of keloid lesions; vascularity of keloid lesions; thickness of keloid lesions; recurrence rate; the number of sessions needed for keloid treatment; complications of treatment including PIH, atrophy, wound, new scarring, pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221209056760N1
Registration date:2023-02-17, 1401/11/28
Registration timing:registered_while_recruiting
Last update:2023-02-17, 1401/11/28
Update count:0
Registration date
2023-02-17, 1401/11/28
Registrant information
Name
Faeghe Mollaabasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7781 2053
Email address
faegheabasi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of intralesional bleomycin plus intralesional triamcinolone in the treatment of keloids in the year of 1401in Loghman and Tajrish hospital
Public title
Comparison of the efficacy of intralesional bleomycin plus intralesional triamcinolone in the treatment of keloids.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between the ages of 18 and 60
Refractory keloid: Relapse or not cured despite six sessions of intra-triamcyonolone acetonide injection.
Exclusion criteria:
Dissatisfaction with the study
sensitivity to bleomycin
pregnant or breast feeding
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti University of Medical Science
Evaluation of the efficacy of keloid treatment by intralesional injection of bleomycin in combination with intralesion injection of triamcinolone.(pigmentation, vascularity, pliability and thickness)
Timepoint
The Beginning of the study and then every 4 weeks and up to 6 sessions (end of study).
Method of measurement
The VSS (Vancouver Scar Scale) scale and examining the patient.
Secondary outcomes
1
Description
Relapse rate
Timepoint
Beginning of the study and then every 4 weeks and up to 6 sessions (end of study)
Method of measurement
The VSS (Vancouver Scar Scale) scale
2
Description
Complication of treatment.
Timepoint
Beginning of the study and then every 4 weeks and up to 6 sessions (end of study).
Method of measurement
observation and asking for the patients.
Intervention groups
1
Description
Intervention group: Patients with refractory keloids referred to the dermatology clinic of Loghman Hakim and Shohada Tajrish hospitals will be treated with intra-lesional of bleomycincin 5 mg and triamcinolone acetonide 40 mg and lidocaine 2% in combination 3:3:3 and every 4 weeks and up to 6 sessions.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman hospital
Full name of responsible person
Faeghe Mollaabasi
Street address
Makhsous Ave
City
Tehran
Province
Tehran
Postal code
1461965381
Phone
+98 21 5541 9005
Email
faegheabasi@yahoo.com
2
Recruitment center
Name of recruitment center
Shohada Tajrish hospital
Full name of responsible person
Faeghe Mollaabasi
Street address
Tajrish Sq
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9201
Email
faegheabasi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Robati
Street address
Velenjak, Shahriari Sq
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9770
Email
faegheabasi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Faeghe Mollaabasi
Position
Resident of dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Velenjak, shahriari Sq
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9770
Email
faegheabasi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Faeghe Mollaabasi
Position
Resident of dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Velenjak, Shahriari Sq
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
faegheabasi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Faeghe Mollaabasi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Velenjak, Shahriari Sq
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
faegheabasi@yahoo.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