Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pierre Fabre Dermatology
Primary objective The primary objective of this study is to identify the appropriate dose and duration of propranolol treatment and demonstrate its superiority over placebo based on the complete/nearly complete resolution of target IH at W24.
Age
0–0
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Proliferating IH (target hemangioma) requiring systemic therapy anywhere on the body except on the diaper area with largest diameter of at least 1.5 cm
You may not be if
\- The patient presents with one or more of the following medical conditions: Congenital hemangioma; Kasabach-Merritt syndrome; bronchial asthma; bronchospasm; hypoglycaemia (\< 40 mg/dl or at risk); untreated phaeochromocytoma; hypotension (\< 50/30 mmHg); second or third degree heart block; cardiogenic shock; metabolic acidosis; bradycardia (\< 80 bpm); severe peripheral arterial circulatory disturbances; Raynaud's phenomenon; sick sinus syndrome; uncontrolled heart failure or Prinzmetal's angina; documented PHACES syndrome with central nervous system involvement
The patient has previously been treated for IH, including any surgical and/or medical procedures (e.g. laser therapy)
The patient is known to have a hypersensitivity to propranolol and/or any other beta-blockers
One or more of the following types of IH are present:
* Life-threatening IH
* Function-threatening IH (e.g. those causing impairment of vision, respiratory compromise caused by airway lesions, etc.)
* Ulcerated IH (whatever the localisation) with pain and lack of response to simple wound care measures
The patient was born prematurely and has not yet reached his/her term equivalent age (e.g. an infant born 2 months prematurely cannot be included before the age of 2 months)
Clareo Health | Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy
