Propranolol Versus Prednisolone for Treatment of Symptomatic Hemangiomas

Nancy Bauman

Status and phase: Terminated; Phase 2

Conditions: Hemangioma of Infancy

Treatments: Drug: Prednisolone; Drug: propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT00967226

IRB 4502

NIH grant number 10179326

Details and patient eligibility

About

Hemangiomas are relatively common lesions in infants. Most go away spontaneously after one year of life and do not need treatment. Others require treatment because they cause significant symptoms such as pain, or difficulty with breathing, eating or ambulating. Steroids have classically been used to treat hemangiomas and help to shrink them in 1/3 - 2/3 of patients. Unfortunately, steroids have many side effects in babies so physicians have sought other ways to treat them. Recently, the use of propranolol, a heart medication, was serendipitously found to reduce the size of hemangiomas. It appears to have many fewer side effects than steroids but it is not yet known if it works as well as steroids. This study seeks to compare the effect and the side effects of propranolol versus steroids for treating hemangiomas that cause symptoms in infants.

Full description

Infants with symptomatic hemangiomas will be enrolled. Magnetic resonance imaging will be completed before starting medication if the extent of the hemangioma is not evident on clinical examination alone. Infants will be randomized to receive either propranolol or steroids for 4-6 months. Hemangioma response will be measured and compared monthly as will tolerability of the medications. Additionally, urine specimens will be collected at each visit to determine if markers are present that can predict response to therapy.

Additionally, any hemangiomas that are excised will be examined for genetic markers to aid in predicting response to therapy.

Enrollment: 19 patients

Sex: All

Ages: 2 weeks to 6 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• infants with symptomatic hemangiomas

Exclusion criteria

• asthma
• diabetes
• hypertension
• hypotension
• hypoglycemia
• liver failure
• previous treatment for hemangiomas

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

19 participants in 2 patient groups

propranolol for treatment of hemangiomas

Experimental group

Description:

Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas

Treatment:

Drug: propranolol

Prednisolone

Active Comparator group

Description:

Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.

Treatment:

Drug: Prednisolone