Nadolol for Proliferating Infantile Hemangiomas

August 13, 2021 updated by: Elena Pope, The Hospital for Sick Children

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 percentage of patients with >75% improvement in the Nadolol group compared to a historical cohort of patients receiving propranolol.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

November 8, 2009

First Submitted That Met QC Criteria

November 9, 2009

First Posted (Estimate)

November 10, 2009

Study Record Updates

Last Update Posted (Actual)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 13, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000014079

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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