Clinical Trial: Nadolol for Proliferating Infantile Hemangiomas

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

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

Brief Summary:

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.


Detailed Summary: 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.
Sponsor: The Hospital for Sick Children

Current Primary Outcome: Proportion of subjects with at least 75% improvement in the extent of the hemangioma [ Time Frame: Baseline, 6months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The proportion of subjects with at least 50% improvement in the extent of the hemangiomas [ Time Frame: Baseline and 6 months ]
  • 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 correlation between the changes in the levels of angiogenesis markers and clinical response to treatment. [ Time Frame: 6 months ]


Original Secondary Outcome: Same as current

Information By: The Hospital for Sick Children

Dates:
Date Received: November 8, 2009
Date Started: November 2009
Date Completion:
Last Updated: August 1, 2013
Last Verified: August 2013