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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01720056
Registration number
NCT01720056
Ethics application status
Date submitted
30/10/2012
Date registered
1/11/2012
Date last updated
10/06/2015
Titles & IDs
Public title
Verapamil vs Steroid to Prevent Keloid Recurrence
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Scientific title
Assessment of Verapamil as an Adjunct for Prevention of Keloid Recurrence After Surgical Removal
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Secondary ID [1]
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EC 067/2012
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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:
Keloid Scars
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Verapamil
Treatment: Drugs - Kenalog 10
Active Comparator: Verapamil - Verapamil 2.5 mg/mL injection sc intralesionally
Active Comparator: Kenalog 10 - Kenalog 10 mg/mL injection sc intralesionally
Treatment: Drugs: Verapamil
Treatment: Drugs: Kenalog 10
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Keloid recurrence
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Assessment method [1]
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Timepoint [1]
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1 year
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Secondary outcome [1]
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Vancouver Scar Scale Score
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Assessment method [1]
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Timepoint [1]
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1 year
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Eligibility
Key inclusion criteria
- Patient undergoing surgical removal of keloid
- Patient 18 years old or greater
- Length of excisional scar after surgical removal of keloid between 2 and 10 cm
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Minimum age
18
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
- Keloid in face or hands
- Pregnancy or lactation
- Dementia
- Any heart or pulmonary condition
- Systemic treatment with beta-blockers, ACE-inhibitors or calcium antagonists
- Systemic corticosteroidal therapy
- Intralesional steroid treatment within 2 months of surgery to remove keloid
- Flap surgery
- Lesions to face, hands and other cosmetically sensitive areas
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Study design
Purpose of the study
Prevention
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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)
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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 receiving the treatment/s
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
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2012
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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
1/03/2014
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Sample size
Target
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Accrual to date
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Final
14
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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6001 - Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Western Australia
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Keloid scarring is a severe cosmetic and painful disease of the skin. The gold standard
treatment is yet to be clarified. This randomized clinical pilot study will compare the
effects of two local treatments for preventing keloid recurrence after surgical removal;
steroid and verapamil.
Study hypothesis: Intralesional therapy with the calcium antagonist verapamil has equal
treatment efficacy as steroid injection.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01720056
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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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Fiona M Wood, Professor
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Address
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The University of Western Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01720056
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