Neoplasms

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Diseases and Abnormalities at or Before Birth

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Hemangioma

Hemangioma, Capillary

Port-Wine Stain

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Congenital Abnormalities

Skin Abnormalities

Skin Diseases

Anti-Arrhythmia Agents

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Central Nervous System Depressants

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Propranolol

Benzocaine

Nadolol

Adrenergic beta-Antagonists

Adrenergic Agents

Adrenergic Antagonists

Neurotransmitter Agents

Sympatholytics

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	Link
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

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