Investigating the effect of triamcinolone acetonide injection in keloid alone and with cryotherapy
Design
A randomized clinical trial that is performed simultaneously in two parallel intervention groups including 32 patients and a total of 64 keloid lesions.
Settings and conduct
This study will be carried out at Razi hospital for 32 patients and 64 keloid lesions. in each patient two keloid lesions will be detected and treated, one lesion is treated with steroid and the other lesion is treated with cryotherapy plus steroid.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 18-65 years, no previous intralesional injection of verapamil or triamcinolone, existence of more than two keloid lesions
Exclusion criteria: pregnancy, lactation, kidney or liver disease, hematologic disease or bone marrow suppression, systemic or local infection, keloid lesion on face
Intervention groups
This study includes two groups. intervention of each groups will be performed on one side of the body which is randomly chosen. first group of intervention will undergo intralesional injection of triamcinolone acetonide alone and the second group will get intralesional injection of triamcinolone acetonide along with cryotherapy
Main outcome variables
The main outcome of the study is to compare the effectiveness of two treatment methods on keloid lesions which is evaluated by POSAS (patient and observer scar assessment scale) questionnaire.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230124057201N2
Registration date:2023-03-24, 1402/01/04
Registration timing:prospective
Last update:2023-03-24, 1402/01/04
Update count:0
Registration date
2023-03-24, 1402/01/04
Registrant information
Name
Zeinab aryanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 0853
Email address
z_aryanian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-03, 1402/01/14
Expected recruitment end date
2023-09-05, 1402/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of intralesional injection of steroid in keloid treatment with and without cryotherapy: a randomized controlled trial
Public title
Effectiveness of steroid injection with and without cryotherapy in the treatment of keloid scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-65 years
Patients who didn't have prior intralesional injection with steroid or verapamil
More than two lesions are available
Exclusion criteria:
Pregnant patients or patients who are intended to get pregnant
Lactation
Underlying kidney or liver disease
Hematologic disorder or bone marrow suppression
Presence of systemic or local infection
Keloid in the face area
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
32
More than 1 sample in each individual
Number of samples in each individual:
2
One side will have single injection of steroid and the other side will have steroid injection with cryotherapy
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation was done with triamcinolone Tr.A and combined treatment Tr.B. Each person is considered as a block. Double blocks are made in a way that the combination AB (A:Tr.A and B:Tr.B) means the right side of person is injected with Tr.A, and the left side is injected with Tr.B. A random number table was used for the random list. a random number was selected, if the number was between 0 and 4, AB combination and if it was between 5 and 9, BA combination was used, this process is repeated until all Eligible patients are included in the study.
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 tehran university of medical science
Street address
Tehran University of medical sience, ghods street,keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2023-01-29, 1401/11/09
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.723
2
Ethics committee
Name of ethics committee
ethics committee of tehtan university of medical science
Street address
Tehran University of medical sience, ghods street,keshavarz boulevard
City
Tehtan
Province
Tehran
Postal code
1417613151
Approval date
2023-01-29, 1401/11/09
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.723
Health conditions studied
1
Description of health condition studied
Keloid
ICD-10 code
L73.0
ICD-10 code description
Acne keloid
Primary outcomes
1
Description
Effectiveness of steroid will be assessed based on POSAS questionnaire
Timepoint
Month 0(baseline), month 3 and month 6
Method of measurement
POSAS(patient and observer scar assessment scale)
Secondary outcomes
1
Description
Effectiveness of steroid with and without cryotherapy based on Fitzpatrick skin type
Timepoint
Month 0(baseline), month 3 and month 6
Method of measurement
Fitzpatrick skin type classification
Intervention groups
1
Description
Intervention group: Keloid lesions of this group will receive intralesional injection of triamcinolone acetonide (40mg/ml) with maximum dose of 20mg/ml for each lesion. injection will be performed every 3 weeks for a total of 4 sessions.
Category
Treatment - Drugs
2
Description
Intervention group: This group of intervention will first receive cryotherapy based on the physician's experience and past guidelines, then immediately the lesion will be injected with triamcinolone acetonide (40 mg/ml) with maximum dose of 20mg/ml, every 3 weeks for a total of 4 sessions.