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Nadolol for Proliferating Infantile Hemangiomas

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ClinicalTrials.gov Identifier: NCT01010308
Recruitment Status : Completed
First Posted : November 10, 2009
Last Update Posted : August 2, 2013
Sponsor:
Information provided by (Responsible Party):
Elena Pope, The Hospital for Sick Children

Study Description
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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.


Condition or disease Intervention/treatment Phase
Infantile Hemangioma Drug: Nadolol Phase 2

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nadolol for Proliferating Infantile Hemangiomas: A Prospective Open Label Study With a Historical Control
Study Start Date : November 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks
Drug Information available for: Nadolol

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Group:

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

 Drug: Nadolol
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.
No Intervention: Historical control group
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.
No Intervention: Angiogenesis marker control group
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.


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

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

Eligibility Criteria
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Ages Eligible for Study:   1 Month to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010308


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Elena Pope, MD The Hospital for Sick Children
More Information
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Responsible Party: Elena Pope, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01010308     History of Changes
Other Study ID Numbers: 1000014079
First Posted: November 10, 2009    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: August 2013
Keywords provided by Elena Pope, The Hospital for Sick Children:
infantile hemangioma
nadolol
Additional relevant MeSH terms:
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Hemangioma
Hemangioma, Capillary
Port-Wine Stain
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Nadolol
Adrenergic beta-Antagonists
 Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents