Nadolol for Proliferating Infantile Hemangiomas

Infantile Hemangioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010308
• Other study ID #: 1000014079
• Status: Completed
• Phase: Phase 2
• Start date: November 2009
• Est. completion date: February 2012

Study information

• Verified date: August 2021
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Hemangioma
• Hemangioma, Capillary
• Infantile Hemangioma
• Port-Wine Stain

Intervention

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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with at least 75% improvement in the extent of the hemangioma		Baseline, 6months
Secondary	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	Baseline and 6 months
Secondary	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.	6 months
Secondary	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.	6 months