Nadolol Versus Propranolol in Children With Infantile Hemangiomas

Official Title

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

Summary:

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.

Trial Description

Primary Outcome:

  • 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).
Secondary Outcome:
  • Percent change in IH bulk using VAS at 4, 12, 52 weeks
  • Time and dose to reach the 50%, 75% and 100% tumour shrinkage
  • Inter-rater reliability of the VAS scores
  • Percentage of patients achieving functional correction at Week 4, 12, 24, 52
  • Percent change in the volumetric changes of hemangioma
  • Percentage of patients with residual changes (telangiectasias, discoloration, fibro-fatty changes, anetoderma)
  • Frequency of observed and reported adverse events
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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society