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Trial registered on ANZCTR
Registration number
ACTRN12625000568415
Ethics application status
Approved
Date submitted
18/02/2025
Date registered
3/06/2025
Date last updated
3/06/2025
Date data sharing statement initially provided
3/06/2025
Type of registration
Retrospectively registered
Titles & IDs
Public title
A clinical trial to compare efficacy of intralesional triamcinolone vs intralesional verapamil in patients with keloids/ hypertrophic scars.
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Scientific title
Comparison of efficacy of intralesional triamcinolone vs intralesional verapamil in treatment of keloids in patients with keloids/hypertrophic scars.
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Secondary ID [1]
314007
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nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
keloids
336738
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hypertrophic scars
336739
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Condition category
Condition code
Skin
333236
333236
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Group A will be recieving intralesional verapamil injection 1ml(2.5mg) every month upto 2 months using 1ml subcutaneous syringe.Efficacy will be determined after 2 months of treatment.
The injections will be administered by a registered nurse.
The strategies that will be used to assess adherence to the intervention will be the use of same brand verapamil injection using sterile 1ml subcutaneous syringe & needle throughout the duration of study which will be strictly administered by a registered nurse who will be dedicated to this specific task under supervision .
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Intervention code [1]
330588
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Treatment: Drugs
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Comparator / control treatment
Group B will be recieving intralesional triamcinolone (40mg/ml) subcutaneously every month upto 2 months, using 1ml subcutaneous syringe
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Control group
Active
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Outcomes
Primary outcome [1]
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To compare the efficacy of intralesional triamcinolone(TAC) and verapamil in the treatment of keloid and hypertrophic scars for mean change in scar height.
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Assessment method [1]
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vancouver scar scale (VSS) with a total score ranging from 0 to 14 by recording the score for each parameter described ahead ; Vascularity (graded as 0,1,2,3), Pigmentation (graded as 0,1,2), Pliability (graded as 0,1,2,3,4 or 5), Scar height ( graded as 0 ,1,2 or 3).
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Timepoint [1]
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after 2 months of the treatment.
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Secondary outcome [1]
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To compare the complications of intralesional triamcinolone (TAC) and intralesional verapamil in the treatment of keloid and hypertrophic scars like skin atrophy, telangiectasias, hypo or hyperpigmentation and skin ulceration as a composite secondary outcome by clinical observation by separate investigator.
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Assessment method [1]
445105
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Vancouver scar scale
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Timepoint [1]
445105
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Secondary outcomes will be assessed by a dedicated separate investigator during each monthly treatment session for 2 months then 2 months after completion of treatment
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Eligibility
Key inclusion criteria
both male and female
age 18-60 years
patients with kelois or hypertrophic scars
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
patients with pregnacy or lactation
patients with family history of keloids.
patients with acromegaly
patients with congestive cardiac disease
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
patients will be allocated randomly equally in two groups (A and B) by blocked randomization technique.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
1/12/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
174
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Accrual to date
5
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Final
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Recruitment outside Australia
Country [1]
26903
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Pakistan
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State/province [1]
26903
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khyber pakhtunkhwa
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
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Country [1]
318513
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Primary sponsor type
Individual
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Name
Noor ul Huda working as resident in khyber teaching hospital Peshawar.
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Address
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Country
Pakistan
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Secondary sponsor category [1]
320902
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None
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Name [1]
320902
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Address [1]
320902
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Country [1]
320902
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317118
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Instituitional research and ethical review board, khyber medical college.
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Ethics committee address [1]
317118
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0919222162, 0919222163, principal@kmc.edu.pk, dean@kmc.edu.pk
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Ethics committee country [1]
317118
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Pakistan
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Date submitted for ethics approval [1]
317118
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05/02/2024
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Approval date [1]
317118
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05/07/2024
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Ethics approval number [1]
317118
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Summary
Brief summary
The objective of study is to establish efficacy and complications of intralesional verapamil for the treatment of keloids and hypertrophic scars. We included a total of 174 patients of more than 18 years of age with no history of congestive cardiac diseases. They were divided into group A, who received intralesional verapamil and group B who received triamcinolone. Total of 2 injections were given at monthly interval.. Patients were assessed at the beginning and then after 2 months after the treatment. efficacy was assessed using vancouver scar scale. efficacy will be labelled as positive if total score reduction 75% or more.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Noor ul huda siddiqui
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Address
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Dermatology unit, khyber teaching hospital ,Main university road peshawar, KPK. Postcode: 25000
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Country
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Pakistan
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Phone
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+923349998577
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Fax
140054
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Email
140054
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[email protected]
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Contact person for public queries
Name
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Noor ul huda siddiqui
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Address
140055
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Dermatology unit, khyber teaching hospital ,Main university road peshawar, KPK. Postcode:25000
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Country
140055
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Pakistan
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Phone
140055
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+923349998577
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Fax
140055
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Email
140055
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[email protected]
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Contact person for scientific queries
Name
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Noor ul huda siddiqui
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Address
140056
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Dermatology unit, khyber teaching hospital , main university road peshawar, KPK. Post code: 25000
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Country
140056
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Pakistan
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Phone
140056
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+923349998577
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Fax
140056
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Email
140056
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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