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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 hemangiomas

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.

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

Page last updated: August 23, 2015

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