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Completed

NCT Number: NCT01010308

Nadolol for Proliferating Infantile Hemangiomas

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.

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Key information

Conditions

Infantile Hemangioma Hemangioma Hemangioma, Capillary Neoplasms Neoplasms by Histologic Type Neoplasms, Vascular Tissue

Age range

1 month–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Hospital for Sick Children

Toronto, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nadolol

Drug

Nadolol will be administered orally at home starting at 0.5 mg/kg/day divided into 2 doses. Weekly, if BP and heart rate are acceptable, the dose will be increased by 0.5 mg/kg/day up to 2 mg/kg/day.

Primary outcomes

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

    Time frame: Baseline, 6months

Secondary outcomes

  1. The proportion of subjects with at least 50% improvement in the extent of the hemangiomas

    Time frame: Baseline and 6 months

    The proportion of subjects with at least 50% improvement in the extent of the hemangiomas

  2. The percentage of patients with >75% improvement in the Nadolol group compared to a historical cohort of patients receiving propranolol.

    Time frame: 6 months

    The percentage of patients with >75% improvement in the Nadolol group compared to a historical cohort of patients receiving propranolol.

  3. The correlation between the changes in the levels of angiogenesis markers and clinical response to treatment.

    Time frame: 6 months

    The correlation between the changes in the levels of angiogenesis markers and clinical response to treatment.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Nov 10, 2009
Registry last updated
Aug 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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