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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
74
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.
The Hospital for Sick Children
Toronto, Ontario, Canada
The change in the bulk (size/extent) and color of the infantile hemangioma (IH)at Week 24 compared to baseline using Visual Analog Scale (VAS).
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
Time frame: 24 weeks
Percent change in IH bulk using VAS at 4, 12, 52 weeks
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: 4, 12, 52 weeks
Time and dose to reach the 50%, 75% and 100% tumor shrinkage
Time frame since the baseline and study medication dose, when patient's IH decreased in size by 50%, 75% and 100%.
Time frame: 52 weeks
Inter-rater reliability of the VAS scores
Two raters will assess the changes in IH for each study patient ( each visit). We will compare these results to assess inter-rater reliability.
Time frame: 52 weeks
Percentage of patients achieving functional correction at Week 4, 12, 24, 52
Percentage of patients achieving functional correction at Week 4, 12, 24, 52
Time frame: 4,12,24,52 weeks
Percent change in the volumetric changes of hemangioma
\[(Length + Width)/2\]3 X 0.07
Time frame: 24 and 52 weeks
Percentage of patients with residual changes (telangiectasias, discoloration, fibro-fatty changes, anetoderma)
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Percentage of patients with residual changes
Time frame: 52 weeks
Frequency of observed and reported adverse events
Frequency of observed and reported adverse events
Time frame: 52 weeks