None listed
Conditions
Interventions
Group 1 Type of group
Propranolol (1 or 3 mg/kg/day for 3 or 6 months)
Group name:Group 2 Type of group
Treatment with placebo for 6 months
Sponsors
Pierre Fabre Dermatologie,
Eligibility
Inclusion criteria
Inclusion criteria: • Written informed consent (s) are obtained for participation in the study and for the use of patient imaging studies, in compliance with national standards, by the parent (s) (s) of the patient or his / her tutor (s) before performing any study procedure. • The patient has between 35 and 150 days, inclusive, at the time of inclusion and, somewhere in the body except in the diaper area, has a proliferating HI (objective hemangioma) that requires systemic therapy and whose maximum diameter is of at least 1.5 cm.
Exclusion criteria
Exclusion criteria: • The patients health status is unstable from a medical point of view and may affect his chances of completing the study. • The patient has one or more of the following medical conditions: Congenital hemangioma; Kasabach-Merritt syndrome; bronchial asthma; bronchospasm; hypoglycemia (<40 mg / dl or at risk); untreated pheochromocytoma; hypotension (<50/30 mmHg); second or third degree heart block; Cardiogenic shock; metabolic acidosis; bradycardia (<80 Ipm); severe circulatory abnormalities in the peripheral arteries; Raynaud´s phenomenon; sick sinus syndrome; uncontrolled heart failure or Prinzmetal angina; PHACES syndrome confirmed with central nervous system involvement. • The patient previously received at least one of the following prohibited medications: systemic corticosteroids (oral, intravenous or intramuscular), intralesional or topical, imiquimod, vincristine, alpha interferon, propranolol or other beta blockers • The patient received prior treatment for HI, including any surgical and / or medical procedure (for example, laser therapy) • The patient´s mother breastfed the patient while receiving treatment with beta blockers (including propranolol) or breastfed the patient during the 15 days prior to random distribution while receiving treatment with systemic corticosteroids (oral, intravenous or intramuscular), vincristine or interferon alfa • It is known that the patient has hypersensitivity to propranolol and / or some other beta blocker • The patient had an anaphylactic reaction before
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:It will be evaluated on the basis of qualitative, centralized, independent, blind and intra-patient (type 1) evaluations of the photographs of the S24 target HI, compared to the baseline period. Measure:Evolution of the target HI from baseline to week 24. Timepoints:week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Based on the qualitative evaluation carried out by the researcher at the center indicating that the objective HI has been completely resolved in S48. In particular, in case of complete resolution of the objective HI in S48, researchers will be asked to evaluate the level of sequelae Measure:Success / failure of treatment Timepoints:Week 48 ; Outcome name:the first improvement after which there is no worsening) of the objective HI on the basis of the qualitative, centralized, type 2 assessments of the patients visit pairs (85, 88, 812, 816, 820 or 824 compared to the baseline period, 85, 88, 812, 816 or 820, respectively). Measure:The time elapsed until the first sustained improvement Timepoints:During the treatment ; Outcome name:(3-point scale: improvement, stabilization, worsening) among the pairs of patient visits (85, 88, 812, 816, 820 or 824 compared to the baseline period, 85, 88, 812, 816 or 820, respectively ). Measure:Categorical parameters for evaluating the evolution of the objective HI Timepoints:During treatment | — |
Countries
Australia, Canada, Czech Republic, France, Germany, Hungaria, Italy, Lithuania, Mexico, New Zealand, Poland, Romania, Russian Federation, Spain, United States
Contacts
Public ContactRosa Adela Chamorro
ICON CLINICAL RESEARCH PERU S.A.
Outcome results
None listed