Trial Review

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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.
Scientific title
Comparison of efficacy of intralesional triamcinolone vs intralesional verapamil in treatment of keloids in patients with keloids/hypertrophic scars.
Secondary ID [1] 314007 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
keloids 336738 0
hypertrophic scars 336739 0
Condition category
Condition code
Skin 333236 333236 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
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 .
Intervention code [1] 330588 0
Treatment: Drugs
Comparator / control treatment
Group B will be recieving intralesional triamcinolone (40mg/ml) subcutaneously every month upto 2 months, using 1ml subcutaneous syringe
Control group
Active

Outcomes
Primary outcome [1] 340800 0
To compare the efficacy of intralesional triamcinolone(TAC) and verapamil in the treatment of keloid and hypertrophic scars for mean change in scar height.
Timepoint [1] 340800 0
after 2 months of the treatment.
Secondary outcome [1] 445105 0
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.
Timepoint [1] 445105 0
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

Eligibility
Key inclusion criteria
both male and female
age 18-60 years
patients with kelois or hypertrophic scars
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with pregnacy or lactation
patients with family history of keloids.
patients with acromegaly
patients with congestive cardiac disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
174
Accrual to date
5
Final
Recruitment outside Australia
Country [1] 26903 0
Pakistan
State/province [1] 26903 0
khyber pakhtunkhwa

Funding & Sponsors
Funding source category [1] 318513 0
Self funded/Unfunded
Name [1] 318513 0
Country [1] 318513 0
Primary sponsor type
Individual
Name
Noor ul Huda working as resident in khyber teaching hospital Peshawar.
Address
Country
Pakistan
Secondary sponsor category [1] 320902 0
None
Name [1] 320902 0
Address [1] 320902 0
Country [1] 320902 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317118 0
Instituitional research and ethical review board, khyber medical college.
Ethics committee address [1] 317118 0
Ethics committee country [1] 317118 0
Pakistan
Date submitted for ethics approval [1] 317118 0
05/02/2024
Approval date [1] 317118 0
05/07/2024
Ethics approval number [1] 317118 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140054 0
Dr Noor ul huda siddiqui
Address 140054 0
Dermatology unit, khyber teaching hospital ,Main university road peshawar, KPK. Postcode: 25000
Country 140054 0
Pakistan
Phone 140054 0
+923349998577
Fax 140054 0
Email 140054 0
[email protected]
Contact person for public queries
Name 140055 0
Noor ul huda siddiqui
Address 140055 0
Dermatology unit, khyber teaching hospital ,Main university road peshawar, KPK. Postcode:25000
Country 140055 0
Pakistan
Phone 140055 0
+923349998577
Fax 140055 0
Email 140055 0
[email protected]
Contact person for scientific queries
Name 140056 0
Noor ul huda siddiqui
Address 140056 0
Dermatology unit, khyber teaching hospital , main university road peshawar, KPK. Post code: 25000
Country 140056 0
Pakistan
Phone 140056 0
+923349998577
Fax 140056 0
Email 140056 0
[email protected]

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.