Back to resultsNadolol for Proliferating Infantile Hemangiomas
Primary Purpose
Infantile Hemangioma
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Nadolol
Sponsored by
About this trial
This is an interventional treatment trial for Infantile Hemangioma focused on measuring infantile hemangioma, nadolol
Eligibility 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
Sites / Locations
- The Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
Intervention Group:
Historical control group
Angiogenesis marker control group
Arm Description
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
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.
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.
Outcomes
Primary Outcome Measures
Proportion of subjects with at least 75% improvement in the extent of the hemangioma
Secondary Outcome Measures
The proportion of subjects with at least 50% improvement in the extent of the hemangiomas
The proportion of subjects with at least 50% improvement in the extent of the hemangiomas
The percentage of patients with >75% improvement in the Nadolol group compared to a historical cohort of patients receiving propranolol.
The percentage of patients with >75% improvement in the Nadolol group compared to a historical cohort of patients receiving propranolol.
The correlation between the changes in the levels of angiogenesis markers and clinical response to treatment.
The correlation between the changes in the levels of angiogenesis markers and clinical response to treatment.
Full Information
NCT ID
NCT01010308
First Posted
November 8, 2009
Last Updated
August 13, 2021
Sponsor
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT01010308
Brief Title
Nadolol for Proliferating Infantile Hemangiomas
Official Title
Nadolol for Proliferating Infantile Hemangiomas: A Prospective Open Label Study With a Historical Control
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Hemangioma
Keywords
infantile hemangioma, nadolol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group:
Arm Type
Experimental
Arm Description
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
Arm Title
Historical control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Angiogenesis marker control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nadolol
Intervention Description
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 Outcome Measure Information:
Title
Proportion of subjects with at least 75% improvement in the extent of the hemangioma
Time Frame
Baseline, 6months
Secondary Outcome Measure Information:
Title
The proportion of subjects with at least 50% improvement in the extent of the hemangiomas
Description
The proportion of subjects with at least 50% improvement in the extent of the hemangiomas
Time Frame
Baseline and 6 months
Title
The percentage of patients with >75% improvement in the Nadolol group compared to a historical cohort of patients receiving propranolol.
Description
The percentage of patients with >75% improvement in the Nadolol group compared to a historical cohort of patients receiving propranolol.
Time Frame
6 months
Title
The correlation between the changes in the levels of angiogenesis markers and clinical response to treatment.
Description
The correlation between the changes in the levels of angiogenesis markers and clinical response to treatment.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Pope, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Nadolol for Proliferating Infantile Hemangiomas
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