Clinical Trial: Nadolol Versus Propranolol in Children With Infantile Hemangiomas

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: The Hospital for Sick Children

Current 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). [ Time Frame: 24 weeks ]

A 100 mm visual analog scale 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percent change in IH bulk using VAS at 4, 12, 52 weeks [ Time Frame: 4, 12, 52 weeks ]
  • Time and dose to reach the 50%, 75% and 100% tumor shrinkage [ Time Frame: 52 weeks ]
  • Inter-rater reliability of the VAS scores [ Time Frame: 52 weeks ]
  • Percentage of patients achieving functional correction at Week 4, 12, 24, 52 [ Time Frame: 52 weeks ]
  • Percent change in the volumetric changes of hemangioma [ Time Frame: 24 and 52 weeks ]
    [(Length + Width)/2]3 X 0.07
  • Percentage of patients with residual changes (telangiectasias, discoloration, fibro-fatty changes, anetoderma) [ Time Frame: 52 weeks ]
  • Frequency of observed and reported adverse events [ Time Frame: 52 weeks ]


Original Secondary Outcome: Same as current

Information By: The Hospital for Sick Children

Dates:
Date Received: July 21, 2015
Date Started: September 2015
Date Completion: December 2017
Last Updated: January 4, 2016
Last Verified: January 2016