Haemagiomas MedDRA version: 12.1 Level: LLT Classification code 10018823 Term: Haemangioma of skin
Conditions
Interventions
Pharmaceutical Form: Syrup
INN or Proposed INN: Propranolol
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2-
Trade Name: DELTACORTENE
Pharmaceutica
Sponsors
ISTITUTO PER L`INFANZIA BURLO GAROFOLO
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed