Open randomized study on propranolol vs prednisone for haemangioma in patients younger than 18 months of age - Propranolol vs prednisone for haemangiomas

• Conditions: Haemagiomas; MedDRA version: 12.1Level: LLTClassification code 10018823Term: Haemangioma of skin

• Registration Number: EUCTR2009-017241-55-IT
• Lead Sponsor: ISTITUTO PER L`INFANZIA BURLO GAROFOLO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Children younger than 18 months with:
1)haemangiomas located in essential organs (orbits, mouth, airway, genitals)
2)heamengiomas with very fast growth, even in other sides;
3)heamangiomas that cause very important esthetical impairment
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Children with:
1)cardiologic contraindications for propranolol treatment (severe bradycardia, total or advanced atrio-ventricular block; diabetes
2)hypersensitivity to propranolol
3)important family history of syncope or vagal hypertony
4)asthma
5)formal contraindications for steroids treatment (diabetes, hypertension)
6)haemangiomas already in involution phase

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the efficacy and safety of propranolol for haemangiomas treatment compared to current therapy (prednisone), in children younger than 18 months.;Secondary Objective: To asses early and delayed side effects for both treatment;Primary end point(s): More or equal efficacy of propranolol, with less side effects than prednisone for haemangiomas