Nadolol for Proliferating Infantile Hemangiomas

The Hospital for Sick Children

Status and phase: Completed; Phase 2

Conditions: Infantile Hemangioma

Treatments: Drug: Nadolol

Study type: Interventional

Funder types: Other

Identifiers

NCT01010308

1000014079

Details and patient eligibility

About

The purpose of this study is to explore the efficacy and safety of Nadolol in hemangiomas of infancy.

The secondary objective is to assess the feasibility of conducting a randomized controlled trial comparing nadolol with corticosteroids and propranolol.

Full description

Systemic corticosteroids are currently the most frequent used medication for treatment of problematic infantile hemangiomas (IH's). Since June 2008, systemic propranolol has been an important addition to the therapeutic options for problematic IH, allowing decreased dependence on the systemic corticosteroids. So far, we have found excellent response with propranolol with minimal short-term side effects. Studies, which compared nadolol and propranolol in children with other conditions, suggest that nadolol is safer and more efficacious than propranolol. In addition, it has better dosing schedules and less central nervous system (CNS) penetration, making it suitable even for patients with suspected or proven PHACES syndrome.

Enrollment: 20 patients

Sex: All

Ages: 1 month to 1 year old

Volunteers: No Healthy Volunteers

Inclusion criteria

Intervention Group

• Infants aged 1 month to 1 year of age with head and neck hemangiomas currently causing /or with impending function loss (e.g. vision, airway obstruction, feeding, etc), or hemangiomas currently causing/or with potential for facial disfigurement.

Historical Control Group

• Infants aged 1 month to 1 year of age with head and neck hemangiomas that received treatment with systemic propranolol in the past 2 years

Angiogenesis Marker Control Group

• Infants aged 1 month to 1 year attending dermatology clinic

Exclusion criteria

Intervention Group

• Patients with PHACES syndrome (proven) or suspected PHACES (plaque like hemangioma awaiting imaging).
• Children with history of hypersensitivity to beta blockers
• Children with personal history or family history of a first degree relative with asthma
• Children with known renal impairment
• Children with known cardiac conditions which may predispose to heart blocks
• Personal history of hypoglycemia
• Children on medications that may interact with beta blockers

Historical Control Group:

• No digital photography available documenting IHs progression

Angiogenesis Marker Control Group:

• Children with IH
• Children on beta blocker or systemic corticosteroids

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Intervention Group:

Experimental group

Description:

The patients in this study are infants aged 1 month to 1 year of age with head and neck hemangiomas currently causing /or with impending function loss (e.g. vision, airway obstruction, feeding, etc), or hemangiomas currently causing/or with potential for facial disfigurement Infants aged 1 month to 1 year of age with head and neck hemangiomas that received treatment with systemic propranolol in the past 2 years as a control group

Treatment:

Drug: Nadolol

Historical control group

No Intervention group

Description:

Ten infants (1-12 months of age) treated with propranolol will be identified from a Dermatology Database. Patients will be considered as controls if they were treated with propranolol before 1 year of age and had digital photography documentation of their hemangioma.

Angiogenesis marker control group

No Intervention group

Description:

The angiogenesis marker control group will consist of 6 -10 patients seen in the Dermatology clinic for conditions other than IH and not receiving corticosteroids or beta blockers.