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Trial registered on ANZCTR


Registration number
ACTRN12611000004965
Ethics application status
Approved
Date submitted
17/12/2010
Date registered
4/01/2011
Date last updated
1/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Propranolol for infantile haemangiomas
Scientific title
A Pilot Randomized Double Blind Placebo Control Study to assess the efficacy and safety of Propranolol hydrochloride to treat Infantile Haemangiomas in children between the ages of 9 weeks to 5 years.
Secondary ID [1] 253314 0
Nil
Universal Trial Number (UTN)
UTN: U1111-1118-7233
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infantile Haemangioma 258842 0
Condition category
Condition code
Skin 258982 258982 0 0
Dermatological conditions
Blood 259018 259018 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Propranolol hydrochloride oral solution 2mg/kg/day divided three times daily for 24 weeks
Intervention code [1] 257762 0
Treatment: Drugs
Comparator / control treatment
2 mg/kg/day of placebo oral solution containing citric acid monohydrate, sodium benzoate,saccharin syrup, and purified water administered three times daily for 24 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 259836 0
Change in infantile haemangioma volume assessed by taking 2 hemispheric tape measure measurements
Timepoint [1] 259836 0
at baseline and weeks 1,4,8,12,16,20,24
Secondary outcome [1] 268690 0
Clinical photography to assess haemangioma color: redness, blueness, and to assess haemangioma elevation
Timepoint [1] 268690 0
baseline, week 12, week 24

Eligibility
Key inclusion criteria
children between the ages of 9 weeks to 5 years with infantile hemangiomas that are deep, or in sites that could impair function or aesthetic disfigurement, or are too late for corticosteroid therapy or that failed to respond to corticosteroid therapy
Minimum age
9 Weeks
Maximum age
5 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
infantile hemangiomas requiring urgent treatment due to impingement on vital structures, contraindications to propranolol such as wheezing or PHACE syndrome (Posterior fossae of the brain, hemangiomas, arterial anomalies, cardiac anomalies and eye anomalies, due to the theoretical risk of cerebral ischemia) extracutaneous hemangiomas that can not be assessed by clinical photography and volume estimation, or inability to participate or follow study treatment and assessment plan.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258227 0
Charities/Societies/Foundations
Name [1] 258227 0
Touched by Olivia Foundation
Address [1] 258227 0
3/6 Wolseley Street Drummoyne NSW 2047
Country [1] 258227 0
Australia
Primary sponsor type
Hospital
Name
Sydney Children's Hospital
Address
Department of Dermatology
Sydney Children's Hospital, 4th Floor
Emergency Wing
High Street, Randwick 2031, NSW
Country
Australia
Secondary sponsor category [1] 257395 0
None
Name [1] 257395 0
Address [1] 257395 0
Country [1] 257395 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Sydney Children's Hospital is doing a study to see whether haemangiomas of infancy (strawberry marks) which are no longer flat or which have continued to grow in spite of oral corticosteroids (cortisone), or present when the baby is too old for steroid treatment, will stop growing and /or shrink when treated with propranolol. A recent report of 11 cases suggests that propranolol may be helpful in shrinking haemangiomas of infancy.
Trial website
Trial related presentations / publications
PEDIATRICS: Decision Letter on MS# 2011-0029.R1 Received: Monday, March 28, 2011, 11:53 AM 28-Mar-2011 RE:  MS#: 2011-0029.R1 Title: A Randomized Controlled Trial of Propranolol for Infantile Hemangiomas Authors: Hogeling, Marcia; Adams, Susan; Wargon, Orli Dear Dr. Hogeling: Thank you for your revised manuscript, which has been accepted by Pediatrics. All accepted papers are published online at www.pediatrics.org, which is the journal of record. The online publication date for your paper is not known at this time.
Public notes

Contacts
Principal investigator
Name 32027 0
Address 32027 0
Country 32027 0
Phone 32027 0
Fax 32027 0
Email 32027 0
Contact person for public queries
Name 15274 0
Orli Wargon
Address 15274 0
Sydney Children's Hospital
4th floor, emergency wing
High Street
Randwick, NSW, 2031
Country 15274 0
Australia
Phone 15274 0
+61 2 9382 2222
Fax 15274 0
Email 15274 0
owargon@bigpond.net.au
Contact person for scientific queries
Name 6202 0
Orli Wargon
Address 6202 0
Sydney Children's Hospital
Country 6202 0
Australia
Phone 6202 0
+ 61 2 9382 2222
Fax 6202 0
Email 6202 0
owargon@bigpond.net.au

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