Efficacy and safety of topical administration of timolol maleate 0.5% solution in the treatment of Child Proliferative Hemangioma Early Stage Surface. Randomized Controlled Study

Institut de Recerca HSCSP0 sites70 target enrollmentApril 25, 2014

Overview

No summary available.

Registry

who.int

Start Date

April 25, 2014

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Institut de Recerca HSCSP

•\- Informed Consent signed by a parent or guardian of the patient, both for study participation and for taking pictures.
•\- The patient is 10 to 60 days old at the time of inclusion.
•\- The patient should have at least:
•\- A mixed both surface, sized from 0\.3 to 5 cm in any location of the body surface focal or segmental hemangioma.; or
•\- A hemangioma precursor defined as pink macules with white halo in periphery, clinically characteristic of the precursors of hemangiomas in infancy; or
•\- A abortion or minimum defined as angiomas proliferation telangiectatic Hemangioma showing proliferation in \<5% of the surface of the hemangioma
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 70
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range

•\- Patients under 10 and over 60 days old at the time of inclusion.
•\- Patients with indication of systemic therapy (ulcerated hemangiomas in mucosal surfaces, disfiguring)
•\- Patients who are with another treatment modality for hemangiomas (beta blockers, corticosteroids, interferon, cyclophosphamide, vincristine)
•\- Hemangiomas associated syndromes (PHACE, LUMBAR, SACRAL, PELVIS)
•\- Hemangiomas affecting any organ or airway
•\- Hemangiomas affecting any organ or airway
•\- Patients with any underlying disease (bronchial asthma, severe lung disease, sinus bradycardia, atrioventricular block second degree, third degree, overt heart failure or cardiogenic shock).
•\- Patients with congenital defects (patients with a chromosomal syndrome, patients with congenital heart disease (tetralogy of Fallot, transposition of the great arteries, ventricular septal defect, atrial septal defect, persistent ductus arteriosus)
•\- Patients with neoplastic disease (leukemias, sarcomas, neuroblastoma, retinoblastoma, etc.)
•\- Hypersensitivity to the active substance or any of the excipients.