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 个研究点目标入组 70 人开始时间: 2014年4月25日最近更新: 2019年12月10日

适应症

试验速览

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•- 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
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 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.

发起方

Institut de Recerca HSCSP