To compare the efficacy of intralesional triamcinolone acetonide and cryotherapy vs intralesional triamcinolone acetonide alone in treatment of keloid.
Design
Pragmatic ,community based ,parallel group ,not blinded ,randomized controlled trial consisting 64 patients divided in two group 32 in each group
Settings and conduct
This study will be conducted in the outpatient clinic of Dermatology PNS Shifa Hospital,Karachi, and will involve patients with keloid.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Either gender, Having single or multiple keloids of size not more than 10 cm in the largest diameter. Patient between 12 to 60 years of age, Willing to sign informed consent
Patients with infected keloid.
Exclusion criteria: Co- existing inflammatory skin diseases. Unrealistic expectation or with psychiatric illnesses, Pre- existing bleeding disorders, Renal and hepatic disease. Lactating or Pregnant women.
Immunodeficient patients. Diseases that react adversely to cold (Raynaud's disease, cryoglobulinemia ,cold urticaria ) and with wound healing abnormalities
Intervention groups
64 Patients group A 32 will be received intralesional steroid and cryotherapy group B will received intralesional steroid alone
Main outcome variables
Change in vascularity , height ,pigmentation and pliability of scar in both groups.
Overall treatment efficacy comparison between the group A (steroid with cryotherapy ) and the group B (steroid only).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241028063523N2
Registration date:2024-11-12, 1403/08/22
Registration timing:registered_while_recruiting
Last update:2024-11-12, 1403/08/22
Update count:0
Registration date
2024-11-12, 1403/08/22
Registrant information
Name
Atiya Rahman
Name of organization / entity
Bahria University of Health Sciences Campus Karachi Pakistan
Country
Pakistan
Phone
+92 21 35319491
Email address
atiyarahman.bumdc@bahria.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-04, 1403/08/14
Expected recruitment end date
2025-05-04, 1404/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of combined intralesional steroid and cryotherapy versus intralesional steroid alone in treatment of keloid.
Public title
Comparison of efficacy of combined intralesional steroid and cryotherapy versus intralesional steroid alone in treatment of keloid.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient of either gender,
Having single or multiple keloids of size not more than 10 cm
Between 12 to 60 years of age
Willing to sign informed consent
Exclusion criteria:
Patient with infected keloids
Co existing inflammatory skin diseases
Unrealistic expectations or with psychiatric illnesses
Pre existing bleeding disorders.
Renal disease and hepatic disease.
Lactating / pregnant women.
Immunodeficient patients , diseases that react adversely to cold (Raynaud's disease, cryoglobulinemia , cold urticaria ) and with wound healing abnormalities will be excluded.
Age
From 12 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
64
More than 1 sample in each individual
Number of samples in each individual:
32
Diagnosis on the clinical basis and given intralesional steroid and cryotherapy versus intralesional steroid
Randomization (investigator's opinion)
Randomized
Randomization description
The keloid patients will randomly be divided into two groups by lottery method which will be administered two different treatment regimens. patient scar will be assessed by Vancouver scar scale.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This will be a hospital based randomized control interventional study consisting of 64 patients ( 32 in each group).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee PNS shifa
Street address
DHA phase ll, PNS Shifa hospital near kala pul.
City
Karachi
Postal code
75500
Approval date
2024-04-04, 1403/01/16
Ethics committee reference number
ERC/2024/DERM/83
Health conditions studied
1
Description of health condition studied
Keloids
ICD-10 code
L73.0
ICD-10 code description
Keloids are dermal proliferations of fibrous tissue that often arise at sites of cutaneous injury and have significant impact on quality of life
Primary outcomes
1
Description
The primary outcome of the study will focus on changes in scar appearance, measured using the Vancouver Scar Scale. This scale evaluates several parameters, including pigmentation, pliability, height, and vascularity, providing a comprehensive assessment of treatment effectiveness. Additionally, patient-reported outcomes will be assessed through the Patient Scar Assessment Scale, specifically evaluating improvements in scar perception, including aspects such as pain, itching, color, stiffness, and thickness, as well as overall patient satisfaction with the appearance of their keloids.
Timepoint
Patient will be assessed at baseline and 4 weeks, 8 weeks , 12 weeks
Method of measurement
Vancouver scar scale and Patient Scar Assessment Scale
Secondary outcomes
1
Description
Secondary outcomes will be evaluated to enhance understanding of treatment efficacy. These include the recurrence rate of keloids, the time to noticeable improvement in scar characteristics, and the incidence of adverse effects in both groups. The study will also assess the impact of treatments on overall quality of life using standardized questionnaires, gather additional patient satisfaction scores, and analyze changes in scar morphology through vancouver scar scale assessments taken before and after treatment.
Timepoint
Patient will be assessed at baseline 4 weeks , 8 weeks , 12 weeks
Method of measurement
Patient scar will be assessed by vancouver scar scale and subjective assessment noticed by patients themselves will be assessed by patient scar assessment scale .
Intervention groups
1
Description
There are no control group there two interventional group. 1. Group A will have 32 patients and the will be receive intralesional steroid treatment in conjunction with cryotherapy. In this group, patients will undergo cryotherapy using liquid nitrogen gas, applied until a freezing halo appears. This procedure will occur over two sessions. After the second thaw, patients will receive the intralesional steroid triamcinolone acetonide trade name ( injection K-cort ampule manufacturer -pharma( pvt) Ltd at a concentration of 40 mg/ml, administered at a dosage of 0.1 ml per cm², not to exceed 1 ml per lesion at baseline and 4 weeks 8 weeks 12 weeks. Treatment responses for both groups will be evaluated using the Vancouver Scar Scale, along with subjective assessments from the patients. The response of treatment shall be entered in pre designed to asses the efficacy of two therapeutic agents . the data will be analyzed using SPSS version 23.
Category
Treatment - Drugs
2
Description
Intervention group: 2. Group B 32 will have and they will be receive only the intralesional steroid, triamcinolone acetonide trade name injection K-cort ampule manufacturer-pharma (Pvt.) Ltd, also at a concentration of 40 mg/ml, with the same dosing parameters as Group A (0.1 ml per cm², not exceeding 1 ml per lesion). at baseline and 4 weeks 8 weeks 12 weeks. Treatment responses for both groups will be evaluated using the Vancouver Scar Scale, along with subjective assessments from the patients. The response of treatment shall be entered in pre designed to asses the efficacy of two therapeutic agents . the data will be analyzed using SPSS version 23.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
PNS Shifa Hospital
Full name of responsible person
Dr Sadia D/O Sardar Ahmed Abbasi
Street address
DHA phase ll, PNS Shifa hospital, near kala pul.
City
Karachi
Postal code
75500
Phone
+92 21 48506540
Email
sadia.abbasi038@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Armed forces Hospital PNS Shifa karachi,Pakistan
Full name of responsible person
Dr Sadia D/O Sardar Ahmed Abbasi
Street address
DHA phase ll, PNS Shifa hospital, near kala pul.
City
Karachi
Postal code
75500
Phone
+92 21 48506540
Email
sadia.abbasi038@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Armed Forces
Proportion provided by this source
100
Public or private sector
Private
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
PNS Shifa
Full name of responsible person
Dr Sadia D/O Sardar Ahmed Abbasi
Position
Resident of dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
DHA phase ll, PNS Shifa hospital, near Kala pul.
City
Karachi
Province
Sindh
Postal code
75500
Phone
+92 21 48506540
Email
sadia.abbasi038@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
PNS Shifa
Full name of responsible person
Dr Sadia D/O Sardar Ahmed Abbasi
Position
Resident of dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
DHA phase ll, PNS Shifa hospital, near kala pul.
City
Karachi
Province
Sindh
Postal code
75500
Phone
+92 21 48506540
Email
sadia.abbasi038@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Armed forces Hospital PNS Shifa Karachi,Pakistan
Full name of responsible person
Dr Sadia D/O Sardar Ahmed Abbasi
Position
Post graduate of Dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
DHA phase ll, PNS Shifa hospital, near Kala pul.
City
Karachi
Province
Sindh
Postal code
75500
Phone
+92 21 48506540
Email
sadia.abbasi038@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Comparison of efficacy of combined intralesional steroid and cryotherapy versus intralesional steroid alone in the treatment of keloid.
When the data will become available and for how long
From may 2025, and it will be available lifelong
To whom data/document is available
It will be available for all healthcare professionals.
Under which criteria data/document could be used
Original article
From where data/document is obtainable
sadia.abbasi038@gmail.com
What processes are involved for a request to access data/document