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Trial registered on ANZCTR
Registration number
ACTRN12612000546853
Ethics application status
Approved
Date submitted
22/05/2012
Date registered
23/05/2012
Date last updated
20/04/2017
Type of registration
Prospectively registered
Titles & IDs
Public title
A clinical trial to study the effects of drug named
Triamcinolone alone or combination of Triamcinolone and 5- Fluorouracil in patients with Keloid or hypertrophic scars
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Scientific title
Comparison of efficacy and safety of intralesional triamcinolone and combination of triamcinolone with 5-fluorouracil in the treatment of keloids and hypertrophic scars: randomised control trial
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Secondary ID [1]
280529
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NIL
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Universal Trial Number (UTN)
U1111-1131-0755
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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
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Hypertrophic scars
286537
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Condition category
Condition code
Skin
286787
286787
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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, all patients will be treated with once weekly intralesional triamcinolone (TAC)10mg (0.25ml of 40mg/ml TAC diluted with 0.75ml injectable normal saline) for a total of 8 sessions.
Group B patients will be treated once weekly with intralesional injection of TAC 4 mg (0.1 ml of 40 mg/ml TAC) mixed with 5-fluorouracil (5-FU) 45 mg (0.9 ml of 50 mg/ml 5-FU) for a total of eight sessions
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Intervention code [1]
284905
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Treatment: Drugs
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Comparator / control treatment
Group A, all patients will be treated with once weekly intralesional triamcinolone (TAC)10mg (0.25ml of 40mg/ml TAC diluted with 0.75ml injectable normal saline) for a total of 8 sessions.
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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 TAC and combination of TAC with 5-FU in the treatment of keloid and hypertrophic scars for mean reduction in scar height
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Assessment method [1]
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Timepoint [1]
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at 4, 8 weeks of treatment and 4 weeks after the end of treatment
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Secondary outcome [1]
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To compare the complications with intralesional TAC alone with that of combination of TAC with 5-FU in the treatment of keloid and hypertrophic scars like skin atrophy, telangiectasias, hypo or hyperpigmentation and skin ulceration by clinical observation by separate investigator
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Assessment method [1]
297522
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Timepoint [1]
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during clinical visits for treatment by a separate investigator for presence of above complications and then again assessed at 4 weeks after treatment.
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Eligibility
Key inclusion criteria
Age above 12 years/either sex
Keloid or hypertrophic scar more than 10mm in size measured clinically
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Minimum age
12
Years
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Maximum age
No limit
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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
History of treatment for scar taken in last 6 months
History of chronic renal failure or serum creatinine > 1.2mg/dl.
Abnormalities in liver function tests (ALT > 35 IU) and blood counts (WBC < 4 or > 11 thousand cells) on laboratory investigations.
Pregnant/lactating women or planning pregnancy
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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)
allocation involved contacting the holder of the allocation schedule who was "off-site"
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a random number table from a statistic book
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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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
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
24/05/2012
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Actual
30/05/2012
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Date of last participant enrolment
Anticipated
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Actual
30/03/2013
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Date of last data collection
Anticipated
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Actual
1/06/2016
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Sample size
Target
120
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Accrual to date
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Final
108
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Recruitment outside Australia
Country [1]
4326
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Pakistan
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State/province [1]
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Punjab
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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]
285290
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Primary sponsor type
Individual
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Name
Farrukh Aslam Khalid
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Address
Department of Plastic Surgery, Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
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Country
Pakistan
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
284149
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Ethical Review Board, Allama Iqbal Medical College, Jinnah Hospital
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Ethics committee address [1]
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Prof. Arif M. Siddiqui
Chairman Ethical Review Board,
Medica Unit 3
Allama Iqbal Medical College, Jinnah Hospital
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
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Ethics committee country [1]
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Pakistan
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Date submitted for ethics approval [1]
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01/09/2009
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Approval date [1]
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14/01/2010
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Ethics approval number [1]
287302
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Summary
Brief summary
The objective of study is to establish safety and efficacy of 5-fluorouracil (5-FU) for the treatment of keloids and hypertrophic scars. We included a total of 120 patients of more than 12 years of age with no history of chronic renal or liver disease. They were divided into group A, who received intralesional triamcinolone acetonide (TAC) alone and group B who received combination of 5-FU and TAC. Total of 8 injections were given at weekly interval. Patients were assessed at the beginning, at 4th and 8th week of treatment and then 4 weeks after the treatment for mean reduction in scar height, efficacy (more than 50% reduction in initial scar height) and complications of both treatments.
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Trial website
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Trial related presentations / publications
Send for presentation at ISBI 2016, Miami
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Public notes
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Contacts
Principal investigator
Name
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Dr Farrukh Aslam Khalid
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Address
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Jinnah Burn and Reconstructive Surgery Centre, Allama Iqbal Medical College, Allama Shabbir Ahmed Usmani Road, Lahore 54550
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Country
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Pakistan
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Phone
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+923009671600
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Farrukh Aslam Khalid
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Address
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Department of Plastic Surgery
Allama Iqbal Medical College/ Jinnah Hospital
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
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Country
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Pakistan
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Phone
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+923009671600
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Farrukh Aslam Khalid
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Address
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Department of Plastic Surgery
Allama Iqbal Medical College/ Jinnah Hospital
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
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Country
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Pakistan
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Phone
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+923009671600
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
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
Source
Title
Year of Publication
DOI
Embase
Comparison of efficacy and safety of intralesional triamcinolone and combination of triamcinolone with 5-fluorouracil in the treatment of keloids and hypertrophic scars: Randomised control trial.
2019
https://dx.doi.org/10.1016/j.burns.2018.08.011
N.B. These documents automatically identified may not have been verified by the study sponsor.
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