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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Comparative Study of the Use of Beta Blocker and Oral Corticosteroid in the Treatment of Proliferative and Involuting Cutaneous Infantile Hemangioma

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 t

Detailed Summary:

  1. Introduction Infantile Hemangioma (IH) is infancy's most common vascular tumor of infancy and most frequent benign neoplasm. In 1996 the "International Society for the Study of Vascular Anomalies" has defined the guidelines for the diagnosis and treatment of vascular anomalies. Hemangioma is one of the many vascular tumors that were classified. Clinically, it presents well defined characteristics and a natural history divided into three phases. The proliferative phase represents an initial growth phase through hyperplasia and hypertrophy, followed by a spontaneous regression phase called the involuting phase. The involuted phase represents a final phase with no more biological activity; however, it doesn't necessarily corresponds to the complete tumor disappearance once there is a replacement by fibro-fatty tissue. IH affects one in every 10 to 20 Caucasian infants.There is a predilection for females at a 3:1 to 5:1 proportion, a higher incidence in premature infants, in newborns with low birth weight, in those whose pregnancy presented placentary anomalies and in neonates from mothers with multiple pregnancies. Fifty to sixty percent of IH affect the head and neck area.

    In the proliferative phase the tumor may reach considerable dimensions and depending on its location and proximity to vital structures, it may result in the obstruction or invasion of organs. This would cause a functional problem and even impose a threat to infant's life. There is a variable incidence of local complications such as necrosis, repetitive ulcerations, bleeding and infections, apart from systemic complications such as coagulopathy and high output cardiac failure.

    After involution, IHs may leave scars or contour deformities resulting in deformities and even
    Sponsor: University of Sao Paulo

    Current Primary Outcome: 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 ]

    Original Primary Outcome: Same as current

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

    Original Secondary Outcome: Same as current

    Information By: University of Sao Paulo

    Dates:
    Date Received: February 18, 2010
    Date Started: January 2010
    Date Completion:
    Last Updated: December 1, 2014
    Last Verified: December 2014