Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000523909
Ethics application status
Approved
Date submitted
17/05/2011
Date registered
23/05/2011
Date last updated
30/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Targeted treatment of haemangioma with captopril
Scientific title
Pilot observational study to confirm the safety and efficacy of captopril in infants with problematic haemangioma
Secondary ID [1] 262186 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Problematic infantile haemangiomas 265868 0
Condition category
Condition code
Skin 266024 266024 0 0
Dermatological conditions
Other 266025 266025 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Captopril oral solution titrated gradually to a maximum dose of 0.6mg/kg/day in 3 divided doses. With a starting dose of 0.15mg/kg/day in 3 divided doses until the child is 1 year of age.
Intervention code [1] 264594 0
Treatment: Drugs
Comparator / control treatment
The literature, from 1999-2009, is clear on the fact that problematic haemangiomas if left untreated will cause disruption to form/function to the child
Control group
Historical

Outcomes
Primary outcome [1] 266772 0
Improved observational changes in the infantile haemangioma as assessed by 2 independent consultant physicians
Timepoint [1] 266772 0
At baseline and every 2 months until the child is 1 year of age
Secondary outcome [1] 276365 0
Clinical photography to assess haemangioma colour
Timepoint [1] 276365 0
baseline and every 2 months until the child is 1 year of age

Eligibility
Key inclusion criteria
: Infants and young children with growing problematic haemangiomas whose parents or guardians are willing, able, and competent to administer prescribed medications. (Problematic haemangiomas are defined in the literature as those that cause disruption to form/function of a child or that ulcerate)
Minimum age
9 Weeks
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parents and guardians who would not consent to participate in this study.
Neonates Infants or children who have underlying cardiovascular disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Before offering the treatment, the child will undergo a full physical examination (as is currently practised for Propranolol). An ECG and echocardiogram will be performed to exclude underlying left ventricular outflow tract obstruction (aortic stenosis and coartation of aorta). A blood sample is taken to exclude underlying renal failure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/10/2010
Actual
29/10/2010
Date of last participant enrolment
Anticipated
Actual
5/11/2010
Date of last data collection
Anticipated
Actual
12/08/2011
Sample size
Target
25
Accrual to date
Final
8
Recruitment outside Australia
Country [1] 3590 0
New Zealand
State/province [1] 3590 0

Funding & Sponsors
Funding source category [1] 267091 0
Hospital
Name [1] 267091 0
Hutt Valley District Health Board
Country [1] 267091 0
New Zealand
Primary sponsor type
Hospital
Name
Hutt Valley District Health Board
Address
High St
Lower Hutt 5040
Country
New Zealand
Secondary sponsor category [1] 264181 0
None
Name [1] 264181 0
Address [1] 264181 0
Country [1] 264181 0
Other collaborator category [1] 252007 0
University
Name [1] 252007 0
School of Biological Sciences, Victoria University of Wellington
Address [1] 252007 0
Kelburn Pde
Wellington 6012
Country [1] 252007 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267071 0
Northen X Regional Ethics Committee
Ethics committee address [1] 267071 0
Ministry of Health
3rd Floor, Ulisys Building
650 Great South Rd
Penrose
Auckland 1061
Ethics committee country [1] 267071 0
New Zealand
Date submitted for ethics approval [1] 267071 0
Approval date [1] 267071 0
24/08/2010
Ethics approval number [1] 267071 0
NTX/10/06/056

Summary
Brief summary
Strawberry birthmark (haemangioma) grows rapidly during infancy before gradually shrinking in later childhood. Rapidly growing haemangiomas can cause significant disfigurement and functional problems including threatened vision and life. The child affected by problematic growing haemangioma is considered for this study because we believe that Captopril, given in small doses could dramatically shrink the birthmark such that surgery and/or laser therapy would not be needed later on. Captopril has been used in infants and children with high blood pressure for many years. Our research suggests that Capopril will specifically target a particular type of cells in the haemangioma that are responsible for its rapid growth. In this study, we would start the child on small doses of Captopril, given by mouth. The medication is maintained until the birthmark is fully regressed or until 12 months of age
Trial website
Nil
Trial related presentations / publications
Treatment of Infantile Haemangioma with Captopril. Brit J Dermatol. 2012; 167: 619-624.
Public notes

Contacts
Principal investigator
Name 32617 0
Dr Swee T Tan
Address 32617 0
Gillies McIndoe Research Institute,
Newtown 6242,
Wellington
Country 32617 0
New Zealand
Phone 32617 0
644 2820366
Fax 32617 0
Email 32617 0
[email protected]
Contact person for public queries
Name 15864 0
Dr Prof Swee T Tan
Address 15864 0
Wellington Regional Plastic Maxillofacial & Burns Unit,
Hutt Hospital
Pvt Bag 31-907 High St; Lower Hutt 5040
Country 15864 0
New Zealand
Phone 15864 0
644 5666 999
Fax 15864 0
Email 15864 0
[email protected]
Contact person for scientific queries
Name 6792 0
Dr Dr Tinte Itinteang
Address 6792 0
Gillies McIndoe Research Institute,
Newtown 6242,
Wellington.
Country 6792 0
New Zealand
Phone 6792 0
644 2820366
Fax 6792 0
Email 6792 0
[email protected]

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
No additional documents have been identified.