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Propranolol for infantile haemangiomas

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.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000004965
Enrollment
40
Registered
2011-01-04
Start date
2009-06-30
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

Propranolol hydrochloride oral solution 2mg/kg/day divided three times daily for 24 weeks

Sponsors

Sydney Children's Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
9 Weeks to 5 Years
Healthy volunteers
No

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026