ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

NIL

Universal Trial Number (UTN)

U1111-1131-0755

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Keloids

Hypertrophic scars

Condition category

Condition code

Skin

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]

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]

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]

at 4, 8 weeks of treatment and 4 weeks after the end of treatment

Secondary outcome [1]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

24/05/2012

Actual

30/05/2012

Date of last participant enrolment

Anticipated

Actual

30/03/2013

Date of last data collection

Anticipated

Actual

1/06/2016

Sample size

Target

120

Accrual to date

Final

108

Recruitment outside Australia

Country [1]

Pakistan

State/province [1]

Punjab

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethical Review Board, Allama Iqbal Medical College, Jinnah Hospital

Ethics committee address [1]

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]

Pakistan

Date submitted for ethics approval [1]

01/09/2009

Approval date [1]

14/01/2010

Ethics approval number [1]

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

Dr Farrukh Aslam Khalid

Address

Jinnah Burn and Reconstructive Surgery Centre, Allama Iqbal Medical College, Allama Shabbir Ahmed Usmani Road, Lahore 54550

Country

Pakistan

Phone

+923009671600

Fax

drfarrukhaslam@gmail.com

Contact person for public queries

Name

Farrukh Aslam Khalid

Address

Department of Plastic Surgery
Allama Iqbal Medical College/ Jinnah Hospital
Allama Shabbir Ahmed Usmani Road,
Lahore 54550

Country

Pakistan

Phone

+923009671600

Fax

drfarrukh83@hotmail.com

Contact person for scientific queries

Name

Farrukh Aslam Khalid

Address

Department of Plastic Surgery
Allama Iqbal Medical College/ Jinnah Hospital
Allama Shabbir Ahmed Usmani Road,
Lahore 54550

Country

Pakistan

Phone

+923009671600

Fax

drfarrukh83@hotmail.com

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.

Trial Review

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Documents added manually

Documents added automatically