Nadolol for Proliferating Infantile Hemangiomas
This study has been completed.
Information provided by (Responsible Party):
Elena Pope, The Hospital for Sick Children
First received: November 8, 2009
Last updated: August 1, 2013
Last verified: August 2013
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Nadolol for Proliferating Infantile Hemangiomas: A Prospective Open Label Study With a Historical Control
Primary Outcome Measures:
- Proportion of subjects with at least 75% improvement in the extent of the hemangioma [ Time Frame: Baseline, 6months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The proportion of subjects with at least 50% improvement in the extent of the hemangiomas [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
- The percentage of patients with >75% improvement in the Nadolol group compared to a historical cohort of patients receiving propranolol. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- The correlation between the changes in the levels of angiogenesis markers and clinical response to treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2011 (Final data collection date for primary outcome measure)
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
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.
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.
|Ages Eligible for Study:
||1 Month to 1 Year
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010308
|The Hospital for Sick Children
|Toronto, Ontario, Canada |
The Hospital for Sick Children
||Elena Pope, MD
||The Hospital for Sick Children
No publications provided
||Elena Pope, Staff Physician, The Hospital for Sick Children
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 8, 2009
||August 1, 2013
||Canada: Health Canada
Keywords provided by The Hospital for Sick Children:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2015
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs