Trial Information
A Randomised, Double Blind, Controlled, Multicentre Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo.
Main
Inclusion Criteria:
- only one proliferating Infantile Hemangioma present anywhere on the body except on
the head, the neck, the hands and on the diaper area, with largest diameter diameter
≥ 1cm and ≤ 5 cm.
Main Exclusion Criteria:
- more than one Infantile Hemangioma with largest diameter ≥ 1cm
- medically unstable health status that may interfere with his/her ability to complete
the study
- Infantile Hemangioma requires, according to Investigator's judgment, a systemic
treatment
- the patient has previously been administered treatment for IH or surgical and/or
medical procedures (e.g. laser therapy) have been performed to treat the IH
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Complete/nearly complete resolution of the Infantile Hemangioma at week 12.
Outcome Description:
Complete/nearly complete resolution of the Infantile Hemangioma at week 12 compared to baseline
Outcome Time Frame:
week 12
Safety Issue:
No
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
V00400 GL 2 01 1A
NCT ID:
NCT01512173
Start Date:
January 2012
Completion Date:
May 2013
Related Keywords:
- Infantile Hemangioma
- Propranolol gel
- Hemangioma
- capillary neoplasm
- vascular tissue
- neoplasm by histologic type
- neoplasm
- therapeutic uses
- pharmacologic actions
- adrenergic beta-antagonists
- adrenergic antagonist
- adrenergics agent
- neurotransmitter agent
- molecular mechanism of pharmacological action
- physiological effects of drugs
- Hemangioma
- Hemangioma, Capillary