Nadolol for Proliferating Infantile Hemangiomas - Full Text View

Purpose

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.

Condition	Intervention	Phase
Infantile Hemangioma	Drug: Nadolol	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Nadolol for Proliferating Infantile Hemangiomas: A Prospective Open Label Study With a Historical Control

Resource links provided by NLM:

MedlinePlus related topics: Birthmarks

Drug Information available for: Nadolol

U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

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 ]


Enrollment:	20
Study Start Date:	November 2009
Study Completion Date:	February 2012
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	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.
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.

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


Ages Eligible for Study:	1 Month to 1 Year (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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

Locations


Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada

Sponsors and Collaborators

The Hospital for Sick Children

Investigators


Principal Investigator:	Elena Pope, MD	The Hospital for Sick Children

More Information


Responsible Party:	Elena Pope, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT01010308 History of Changes
Other Study ID Numbers:	1000014079
Study First Received:	November 8, 2009
Last Updated:	August 1, 2013
Health Authority:	Canada: Health Canada

Keywords provided by The Hospital for Sick Children:


infantile hemangioma nadolol

Additional relevant MeSH terms:


Hemangioma Hemangioma, Capillary Port-Wine Stain Neoplasms, Vascular Tissue Neoplasms by Histologic Type Neoplasms Skin Abnormalities Congenital Abnormalities Skin Diseases Nadolol Adrenergic beta-Antagonists	Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents Antihypertensive Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 23, 2016