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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
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
Secondary ID [1] 280529 0
NIL
Universal Trial Number (UTN)
U1111-1131-0755
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Keloids 286524 0
Hypertrophic scars 286537 0
Condition category
Condition code
Skin 286787 286787 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 284905 0
Treatment: Drugs
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.
Control group
Active

Outcomes
Primary outcome [1] 287159 0
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
Timepoint [1] 287159 0
at 4, 8 weeks of treatment and 4 weeks after the end of treatment
Secondary outcome [1] 297522 0
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
Timepoint [1] 297522 0
during clinical visits for treatment by a separate investigator for presence of above complications and then again assessed at 4 weeks after treatment.

Eligibility
Key inclusion criteria
Age above 12 years/either sex
Keloid or hypertrophic scar more than 10mm in size measured clinically
Minimum age
12 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

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)
allocation involved contacting the holder of the allocation schedule who was "off-site"
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
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4326 0
Pakistan
State/province [1] 4326 0
Punjab

Funding & Sponsors
Funding source category [1] 285290 0
Self funded/Unfunded
Name [1] 285290 0
Address [1] 285290 0
Country [1] 285290 0
Primary sponsor type
Individual
Name
Farrukh Aslam Khalid
Address
Department of Plastic Surgery, Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country
Pakistan
Secondary sponsor category [1] 284149 0
None
Name [1] 284149 0
Address [1] 284149 0
Country [1] 284149 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287302 0
Ethical Review Board, Allama Iqbal Medical College, Jinnah Hospital
Ethics committee address [1] 287302 0
Prof. Arif M. Siddiqui
Chairman Ethical Review Board,
Medica Unit 3
Allama Iqbal Medical College, Jinnah Hospital
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Ethics committee country [1] 287302 0
Pakistan
Date submitted for ethics approval [1] 287302 0
01/09/2009
Approval date [1] 287302 0
14/01/2010
Ethics approval number [1] 287302 0

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.
Trial website
Trial related presentations / publications
Send for presentation at ISBI 2016, Miami
Public notes

Contacts
Principal investigator
Name 34208 0
Dr Farrukh Aslam Khalid
Address 34208 0
Jinnah Burn and Reconstructive Surgery Centre, Allama Iqbal Medical College, Allama Shabbir Ahmed Usmani Road, Lahore 54550
Country 34208 0
Pakistan
Phone 34208 0
+923009671600
Fax 34208 0
Email 34208 0
drfarrukhaslam@gmail.com
Contact person for public queries
Name 17455 0
Dr Farrukh Aslam Khalid
Address 17455 0
Department of Plastic Surgery
Allama Iqbal Medical College/ Jinnah Hospital
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country 17455 0
Pakistan
Phone 17455 0
+923009671600
Fax 17455 0
Email 17455 0
drfarrukh83@hotmail.com
Contact person for scientific queries
Name 8383 0
Dr Farrukh Aslam Khalid
Address 8383 0
Department of Plastic Surgery
Allama Iqbal Medical College/ Jinnah Hospital
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country 8383 0
Pakistan
Phone 8383 0
+923009671600
Fax 8383 0
Email 8383 0
drfarrukh83@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary