Comparative Study of the Use of Beta Blocker and Oral Corticosteroid in the Treatment of Infantile Hemangioma
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
Infantile Hemangioma (IH) is infancy's most common vascular tumor of infancy and most
frequent benign neoplasm.
Treatment of IHs is indicated for approximately 10 to 20% of the cases. Two groups can be
defined amongst indications for treatment: patients with absolute indication for treatment
and patients with relative indication for treatment.
Absolute or emergency indications comprise function or life threatening situations such as
obstruction of airways, obstruction of vision, congestive heart failure, hepatic and
coagulation problems.
The following are considered relative indications: cases of large and disfiguring facial
hemangiomas; locations that can result in a deformity and/ or permanent scar (nose, ear, lip,
glabellar area); extensive face hemangiomas, mainly when there is dermal damage (more
probable to scar); local complications such as ulceration, infection and bleeding as well as
small hemangiomas in exposed areas (hands and face), mainly if pedunculated due to its ease
of excision2,7.
Treatment modalities vary according to the extension, location, presence of complications and
the evolutional phase. A combination of various treatments is possible.
Beta blockers are being used in children for approximately 40 years, with proven clinical
safety and no cases of death or cardiovascular disease resulting from its direct use.
Recently it was reported the use of beta blockers (propanolol) for IH treatment, with
significant reduction of tumor volume after introduction of the beta blocker, in a short
period of time, with stable results after the end of treatment, which suggested evidences of
the benefits of this drug in the tumor treatment The proposal of this study is to assess the
use of propanolol in IH treatment, quantifying its effectiveness and safety under continuous
monitoring and comparing it to the use of oral corticosteroid. The investigators propose the
assessment of the betablockers' use in comparison to the use of corticosteroids in infants
with IH in the proliferative or involuting phases, with indication for clinical treatment,
and that are not alarming nor urgent; in other words, the current relative indications for
treatment.