Comparative Study of the Use of Beta Blocker and Oral Corticosteroid in the Treatment of Infantile Hemangioma
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Comparative Study of the Use of Beta Blocker and Oral Corticosteroid in the Treatment of Proliferative and Involuting Cutaneous Infantile Hemangioma|
- Reduction on tumor volume, based on direct measurement (in centimeters, 2 axis) and photographic analysis (same photo camera, obtained by the same technician) [ Time Frame: weekly in the first two months and twice a week in the following months ] [ Designated as safety issue: No ]
- evidence of collateral effects [ Time Frame: weekly on the first 2 weeks and twice a week on the following months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Propranolol
Oral propranolol, at a dose of 2mg/kg/day, divided in 2 doses.
Oral propranolol, at a dose of 2mg/kg/day, divided in 2 doses, for initial 60 days
Other Name: beta-blockers
Active Comparator: Prednisone
Oral prednisone , at a dose of 2mg/kg/day, divided in 2 doses.
Oral prednisone, at a dose of 2mg/kg/day, divided in 2 doses, for initial 60 days
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|Contact: Dov C Goldenberg, MDfirstname.lastname@example.org|
|Contact: Lilian M Cristofani, MDemail@example.com|
|Instituto de Tratamento do Câncer Infantil (Pediatric Cancer Treatment Institute) - ITACI - ICr-HCFMUSP (Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo)||Recruiting|
|Sao Paulo, Brazil, 05403-900|
|Contact: Dov C Goldenberg, MD +55-11- 5539-7741 firstname.lastname@example.org|
|Contact: Lilian M Cristofani, MD +55-11-38973811 email@example.com|
|Principal Investigator: Dov C Goldenberg, MD|
|Study Director:||Dov C Goldenberg, MD||Division of Plastic Surgery - Hospital das Clinicas - University of Sao Paulo School of Medicine|