Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Assessment of Verapamil as an Adjunct for Prevention of Keloid Recurrence After Surgical Removal
Secondary ID [1] 0 0
EC 067/2012
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Keloid Scars 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active comparator: Verapamil - Verapamil 2.5 mg/mL injection sc intralesionally

Active comparator: Kenalog 10 - Kenalog 10 mg/mL injection sc intralesionally
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Keloid recurrence
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Vancouver Scar Scale Score
Timepoint [1] 0 0
1 year

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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 receiving the treatment/s

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

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2014
Sample size
Target
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
6001 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Western Australia
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01720056
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Fiona M Wood, Professor
Address 0 0
The University of Western Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01720056