Neoplasms

All Conditions

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Hemangioma

Hemangioma, Capillary

Port-Wine Stain

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Congenital Abnormalities

Skin Abnormalities

Skin Diseases

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasodilator Agents

All Drugs and Chemicals

Propranolol

Adrenergic beta-Antagonists

Nadolol

Adrenergic Agents

Adrenergic Antagonists

Neurotransmitter Agents

Sympatholytics

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

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.

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.

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.

Elena Pope, MD

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.

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.

Nadolol for Proliferating Infantile Hemangiomas

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

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.

The Hospital for Sick Children

Staff Physician

Central Nervous System Depressants

Other Dietary Supplements

Benzocaine

Tannic Acid

40 study participants will take Nadolol (oral liquid suspension)

40 study paticipants will take Propranolol (oral liquid suspension)

Patients will be administered twice-daily doses of medication as follows: since Day 0- 0.5 mg/kg/day ; since Day 7-1.0 mg/kg/day and since Day 14- 1.5 mg/kg/day. In all subsequent visits the dosage will be adjusted based on the current weight rather than the baseline weight to maintain 1.5 mg/kg/day. Or the dose may be escalated (by 0.5 mg/kg/day at any following study visit) up to 3 mg/kg/day based on the clinical response to maintain the dose that led to at least 75% reduction in the hemangioma size until Week 24, when unblinding happen. At Week 24 paticipants can start weaning by 10% per week or continue with the last dose, depending on the investigator's decision.

S/he will be monitored until Week 52.

Patients will be administered twice-daily doses of medication as follows: since Day 0- 0.5 mg/kg/day ; since Day 7-1.0 mg/kg/day and since Day 14- 1.5 mg/kg/day.

In all subsequent visits the dosage will be adjusted based on the current weight rather than the baseline weight to maintain 1.5 mg/kg/day. Or the dose may be increased by investigator, based on clinical response by 0.5 mg/kg/day at any study visit (up to 3 mg/kg/day divided twice a day) to maintain the dose that lead to at least 75% reduction in the hemangioma size until Week 24, when unblinding happen. At Week 24 paticipants can start weaning by 10% per week or continue with the last dose, depending on the investigator's decision.

S/he will be monitored until Week 52.

Elena Pope, MD, MSc

The purpose of this study is to assess the efficacy and safety of oral propranolol versus nadolol in patients with Infantile Hemangiomas (IH) in a randomized, controlled, double-blinded study.

The study objective is to compare the efficacy and safety of oral propranolol in comparison with oral nadolol in patients with IH. Patients will be randomly assigned to either propranolol or dose equivalent nadolol. The duration of the study will be 24 weeks, however, patient will be monitored for up to 1 year post study enrolment. Both efficacy and safety will be closely monitored and captured.

Nadolol Versus Propranolol in Children With Infantile Hemangiomas

Nadolol Versus Propranolol in Children With Infantile Hemangiomas: a Randomized, Controlled, Double-blinded Trial

A 100 mm visual analog scale (VAS) will be used to quantify changes in the visible bulk (size/extent) and color of the lesion by comparing clinical photographs at 24 weeks versus baseline

A 100 mm visual analog scale (VAS) will be used to quantify changes in the visible bulk (size/extent) of the lesion by comparing clinical photographs at weeks 4, 12, and 52 versus baseline

Time frame since the baseline and study medication dose, when patient's IH decreased in size by 50%, 75% and 100%.

Two raters will assess the changes in IH for each study patient ( each visit). We will compare these results to assess inter-rater reliability.

Percentage of patients achieving functional correction at Week 4, 12, 24, 52

Percentage of patients with residual changes

Frequency of observed and reported adverse events

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nadolol for Proliferating Infantile Hemangiomas	NCT01010308	Infantile Heman...	Nadolol	1 Month - 1 Year	The Hospital for Sick Children
Nadolol Versus Propranolol in Children With Infantile Hemangiomas	NCT02505971	Infantile Heman...	Nadolol Propranolol	1 Month - 6 Months	The Hospital for Sick Children
Nadolol Versus Propranolol in Children With Infantile Hemangiomas	NCT02505971	Infantile Heman...	Nadolol Propranolol	1 Month - 6 Months	The Hospital for Sick Children
Nadolol for Proliferating Infantile Hemangiomas	NCT01010308	Infantile Heman...	Nadolol	1 Month - 1 Year	The Hospital for Sick Children
Nadolol for Proliferating Infantile Hemangiomas	NCT01010308	Infantile Heman...	Nadolol	1 Month - 1 Year	The Hospital for Sick Children

Spots Global Cancer Trial Database for nadolol

Every month we try and update this database with for nadolol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nadolol

Every month we try and update this database with for nadolol cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nadolol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.