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Nadolol for Proliferating Infantile Hemangiomas: A Prospective Open Label Study With a Historical Control


Phase 2
1 Month
1 Year
Open (Enrolling)
Both
Infantile Hemangioma

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Trial Information

Nadolol for Proliferating Infantile Hemangiomas: A Prospective Open Label Study With a Historical Control


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of subjects with at least 75% improvement in the extent of the hemangioma

Outcome Time Frame:

Baseline, 6months

Safety Issue:

No

Principal Investigator

Elena Pope, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Hospital for Sick Children

Authority:

Canada: Health Canada

Study ID:

1000014079

NCT ID:

NCT01010308

Start Date:

November 2009

Completion Date:

February 2012

Related Keywords:

  • Infantile Hemangioma
  • infantile hemangioma
  • nadolol
  • Hemangioma
  • Hemangioma, Capillary

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