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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258227 0
Name [1] 258227 0
Touched by Olivia Foundation
Address [1] 258227 0
3/6 Wolseley Street Drummoyne NSW 2047
Country [1] 258227 0
Primary sponsor type
Sydney Children's Hospital
Department of Dermatology
Sydney Children's Hospital, 4th Floor
Emergency Wing
High Street, Randwick 2031, NSW
Secondary sponsor category [1] 257395 0
Name [1] 257395 0
Address [1] 257395 0
Country [1] 257395 0

Ethics approval
Ethics application status

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, which is the journal of record. The online publication date for your paper is not known at this time.
Public notes

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
Phone 15274 0
+61 2 9382 2222
Fax 15274 0
Email 15274 0
Contact person for scientific queries
Name 6202 0
Orli Wargon
Address 6202 0
Sydney Children's Hospital
Country 6202 0
Phone 6202 0
+ 61 2 9382 2222
Fax 6202 0
Email 6202 0

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