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Comparative Study of the Use of Beta Blocker and Oral Corticosteroid in the Treatment of Infantile Hemangioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01072045
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : December 2, 2014
University of Sao Paulo General Hospital
Information provided by (Responsible Party):
Dov Charles Goldenberg, University of Sao Paulo

Brief 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.

Condition or disease Intervention/treatment Phase
Hemangioma Drug: Propranolol Drug: Prednisone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks Steroids

Arm Intervention/treatment
Active Comparator: Propranolol
Oral propranolol, at a dose of 2mg/kg/day, divided in 2 doses.
Drug: Propranolol
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.
Drug: Prednisone
Oral prednisone, at a dose of 2mg/kg/day, divided in 2 doses, for initial 60 days
Other Names:
  • corticosteroid
  • metilprednisolone

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. evidence of collateral effects [ Time Frame: weekly on the first 2 weeks and twice a week on the following months ]

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with ages up to 2 years;
  • Clinically diagnosed hemangioma, in proliferative or involutive phase, with relative indication for clinical treatment, as itemized:
  • lesion causing alteration of regional anatomy with no systemic or functional damage and with a diameter greater than 1 centimeter, or
  • lesion causing aesthetic deformity, or
  • lesion causing local repetitive complications such as ulceration, bleeding or local infection, or
  • lesion causing partial damage of orifices, or
  • lesion causing psychological compromise.
  • Absence of cardiopathy (normal physical examination, anamnesis, echocardiography, electrocardiography and thoracic radiography);
  • Informed consent signed by responsible parties

Exclusion Criteria:

  • Hemangioma with absolute indication for treatment, presenting a risk to function or life;
  • Patients with previous treatment for infantile hemangiomas;
  • Cardiac disease;
  • Pulmonary disease (asthma, bronchiolitis,bronchopulmonary dysplasias)
  • Raynaud syndrome;
  • Pheochromocytoma;
  • Altered echocardiography, even if asymptomatic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01072045

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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)
Sao Paulo, Brazil, 05403-900
Sponsors and Collaborators
University of Sao Paulo
University of Sao Paulo General Hospital
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Study Director: Dov C Goldenberg, MD Division of Plastic Surgery - Hospital das Clinicas - University of Sao Paulo School of Medicine
Additional Information:

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Responsible Party: Dov Charles Goldenberg, Professor of Surgery, Division of Plastic Surgery, Haspital dasd Clinicas, University of Sao Paulo, University of Sao Paulo Identifier: NCT01072045    
Other Study ID Numbers: CAPPesq0931/09
First Posted: February 19, 2010    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014
Keywords provided by Dov Charles Goldenberg, University of Sao Paulo:
Proliferative hemangioma
Additional relevant MeSH terms:
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Hemangioma, Capillary
Port-Wine Stain
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents