Nadolol for Proliferating Infantile Hemangiomas
Information source: The Hospital for Sick Children
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infantile Hemangioma
Intervention: Nadolol (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: The Hospital for Sick Children Official(s) and/or principal investigator(s): Elena Pope, MD, Principal Investigator, Affiliation: The Hospital for Sick Children
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.
Clinical Details
Official title: Nadolol for Proliferating Infantile Hemangiomas: A Prospective Open Label Study With a Historical Control
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Proportion of subjects with at least 75% improvement in the extent of the hemangioma
Secondary outcome: The proportion of subjects with at least 50% improvement in the extent of the hemangiomasThe 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.
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.
Eligibility
Minimum age: 1 Month.
Maximum age: 1 Year.
Gender(s): Both.
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
Locations and Contacts
The Hospital for Sick Children, Toronto, Ontario, Canada
Additional Information
Starting date: November 2009
Last updated: August 1, 2013
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